Clinical trial NCT03262701
Conditions: Periodontitis, Chronic
Sponsor: Loma Linda University
Start date: 2018-04-02; Completion date: 2021-02-08
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There have been many adjunctive treatments for the additional clinical benefits to scaling and root planing (SRP) in the treatment of chronic periodontitis. Topical hydrogen peroxide (HP) delivered in a custom fabricated tray has been shown to improve pocket depth (PD) and inflammation. The purpose of this study is to assess the adjunctive treatment outcome of HP gel in custom tray application in individuals with chronic periodontitis receiving SRP. The purpose of this investigator-initiated study is to evaluate and compare the clinical effects of scaling and root planing (SRP) combined with local delivery of 1.7% hydrogen peroxide (HP) gel in customized trays to that of SRP alone.

Detailed description:
Hydrogen peroxide (HP) has been used in for wound debridement and oral rinses in dentistry for a few decades. It is widely available in a bottle of 3% in liquid. The use of hydrogen peroxide in gel type in 1.7% as an adjunct to conventional periodontal therapy has been introduced but there are limited information on the efficacy. The current study is to design to evaluate the adjunctive treatment outcome of hydrogen peroxide gel in custom tray application in individuals with chronic periodontitis receiving non surgical therapy, scaling and root planing(SRP). To test the adjunct effect of HP gel in tray, there will be three parallel arms, one with the gel for the period of 26 week, one with the gel for 13 weeks and control group without the gel.

Arms: arm 1: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks. arm 2: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks. arm 3: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
Interventions: intervention 1: Hydrogen Peroxide Gel, 13 weeks intervention 2: Hydrogen Peroxide Gel, 26 weeks intervention 3: Scaling and Root planing group
Intervention descriptions: intervention 1: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis. intervention 2: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis. intervention 3: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
LOMA LINDA UNIVERSITY 
School of Dentistry 
in conjunction with the 
Faculty of Graduate Studies 
 
 
 
____________________ 
 
 
 
 
Custom Application of Peroxide Gel as Adjunct to Scaling/Root Planning in Treatment of 
Periodontitis 
 
 
by 
 
 
Joseph J. Kim 
 
 
 
____________________ 
 
 
 
 
A Thesis submitted in partial satisfaction of 
the requirements for the degree 
Master of Science in Periodontics 
 
 
____________________ 
 
 
 
 
September 2019 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© 2019 
 
Joseph Kim 
All Rights Reserved 


 
iii 
Each person whose signature appears below certifies that this thesis in his/her opinion is 
adequate, in scope and quality, as a thesis for the degree Master of Science. 
 
 
 
 
 
                                                                                                                            Chairperson 
Yoon Jeong Kim, Associate Professor of Periodontics,   
 
 
 
 
 
 
Erik Sahl, Associate Professor of Periodontics 
 
 
 
 
 
 
Tord Lundgren, Professor of Periodontics 
 
 


 
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ACKNOWLEDGEMENTS 
 
 
 
I would like to thank Loma Linda University and the entire Advanced Specialty 
Education Program in Periodontics, LLUSD, for this opportunity to pursue and earn my 
Master of Science in Periodontics.  
 
A very special ‘Thank You’ to my research guidance committee for their direction 
with this research. I would also like to thank Dr. Oyoyo and Dr. Alqahtani for their help 
with the statistical analysis. 
To my wife, Susan, for her unending love and support. 
 


 
v 
CONTENT 
 
 
Approval Page .................................................................................................................... iii 
 
Acknowledgements ............................................................................................................ iv 
 
List of Figures .................................................................................................................... vi 
 
Abstract ............................................................................................................................ viii 
 
Chapter 
 
1. Introduction ..............................................................................................................1 
 
 
2. Materials and Methods .............................................................................................4 
 
Trial Design .......................................................................................................4 
Screening and Recruitment of Patients ..............................................................4 
Eligibility Criteria ..............................................................................................5 
Exclusion Criteria ..............................................................................................5 
Interventions ......................................................................................................6 
Therapy ..............................................................................................................7 
Treatment ...........................................................................................................7 
Maintenance .......................................................................................................8 
Standardized OHI...............................................................................................8 
Non-Surgical Periodontal Therapy ....................................................................9 
Custom HP Tray Fabrication .............................................................................9 
Custom HP Tray Application...........................................................................10 
Outcomes of Clinical Assessment ...................................................................10 
Clnical Periodontal Parameters ........................................................................10 
Examiner Reproducibility ................................................................................12 
Randomization; Sequence, Allocation, and Implementation ...........................12 
Follow Up Care ................................................................................................13 
Study Schedule.................................................................................................13 
Statistical Analysis ...........................................................................................16 
 
3. Results ....................................................................................................................17 
 
4. Discussion ..............................................................................................................28 
 
5. Conclusion .............................................................................................................29 
 
References ..........................................................................................................................30 
 


 
vi 
 FIGURES 
 
 
Figures 
Page 
 
1. CONSORT Flow Diagram .....................................................................................15 
2. Mean PD in each group, SRP, HP13, and HP26 ...................................................18 
3. Mean R-Rec in each group, SRP, HP13, and HP26 ..............................................19 
4. Mean RAL in each group, SRP, HP13, and HP26.................................................20 
5. Baseline MQH scores for SRP, HP13, and HP26 ..................................................21 
6. 4-Week MQH scores for SRP, HP13, and HP26 ...................................................22 
7. Re-Evaluation MQH scores for SRP, HP13, and HP26 ........................................23 
8. Final MQH scores for SRP, HP13, and HP26 .......................................................24 
9. Mean BOP in each group, SRP, HP13, and HP26 .................................................25 
10. BOP % in pockets initially <5 mm ........................................................................25 
11. BOP % in pockets initially >5mm .........................................................................26 


 
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ABBREVIATIONS 
 
 
HP 
 
 
 
Hydrogen Peroxide 
HP13  
 
 
13-Week Hydrogen Peroxide Group 
HP26  
 
 
26-Week Hydrogen Peroxide Group 
OHI 
 
 
 
Oral Hygiene Instruction 
SRP 
 
 
 
Scaling and Root Planing 
PD 
 
 
 
Pocket Depth 
R-Rec  
 
 
Relative Recession 
RAL  
 
 
Relative Attachment Level 
BOP 
 
 
 
Bleeding on probing 
MQH   
 
 
Modified Quigley-Hein Plaque Index  


 
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ABSTRACT OF THE THESIS 
 
 
Custom Application of Peroxide Gel as Adjunct to Scaling/Root planning in Treatment of 
Periodontitis 
 
by 
Joseph J. Kim 
Master of Science, Graduate Program in Periodontics 
Loma Linda University, September 2019 
Dr. Yoon Jeong Kim, Chairperson 
 
Aim: This study was aimed to evaluate and compare the clinical effects of scaling and 
root planning (SRP) combined with local delivery of 1.7% HP in customized trays to that 
of SRP alone. 
Materials and Methods: Sixty patients with generalized moderate to chronic severe 
periodontitis will be assigned to three groups treated by SRP plus HP gel with a custom 
prescription tray application. The test groups will receive twice daily 1.7% HP gel in 
custom trays four weeks prior to SRP and will continue to application for up to 3- and 6-
months post-SRP. Baseline data that is collected at the start of the study will be collected 
again at 4, 13, and 26 weeks post-SRP and analyzed for any changes and thus main 
outcome variables will include changes in pocket depth (PD), relative recession (R-Rec), 
relative attachment level (RAL), and changes in bleeding (BOP) using ANCOVA of 
main effects.  
Results: Repeated measure ANOVA showed significant difference in pocket depth 
among all time points in all treatment groups. Mean BOP was significantly reduced in all 
groups between 4-week examination and re-evaluation with mean BOP scores at final 


 
ix 
examination staying similar to levels at re-evaluation for HP13 and HP26 groups. Mean 
BOP scores at final examination group for SRP group was similar to baseline. 
Discussion: The use of adjunctive HP in custom fabricated trays presents with no adverse 
effects. Significant improvement was evident in pocket depth and attachment level in 
both treatment groups between after 4 weeks of using the tray. No significant effect 
found in SRP group between baseline and 4 weeks. After SRP, significant difference was 
seen in all three groups between 4 weeks and 3 months.


 
1 
CHAPTER ONE 
INTRODUCTION AND REVIEW OF THE LITERATURE 
 
 
Currently, the primary non-surgical treatment for chronic periodontitis consists of 
supra- and subgingival plaque (biofilm) removal and mechanical debridement to reduce 
the periodontal bacterial load 1-3. This localized, professionally administered therapy, 
commonly referred to as scaling and root planing (SRP), usually results in clinical 
improvement and decreases the progression of the disease 4-6. 
SRP alone has significant limitations since studies showed that it is impossible to 
eliminate subgingival calculus completely and bacteria in dentin tubules 7-10. 
Consequently, viable bacteria that remain after SRP repopulate subgingivally, and 
bacteria constantly introduced into the mouth result in new biofilm formation 11, 12. As a 
result, it is necessary to repeat mechanical debridement at least every three months during 
periodontal maintenance. For these reasons, numerous adjunctive treatments have been 
investigated and many sustained or controlled-release local delivery of antimicrobial or 
chemotherapeutic agents are used in the treatment of periodontitis13. In addition, there are 
several problems and limitations associated with the adjunctive therapies for both patients 
and clinicians, including home care restrictions for brushing and flossing around treated 
sites, unsuitability for shallow pockets (<5mm), biofilm resistance to antibiotics, and etc. 
13, 14. 
Topical hydrogen peroxide (HP) application can circumvent many of the limitations and 
has been shown to reduce plaque and gingival inflammation 15, 16. Aqueous HP at low 
concentrations, which has long been used as a debriding agent and wound cleanser, also 
has an extensive history of topical application with SRP 17-20. Perio Protect® is a treatment 


 
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method combining mechanical and chemical debridement with 1.7% HP gel 21. The HP 
gel is directed into periodontal pockets via a custom tray, as an aid to manage biofilms 
better for patients with gingivitis and periodontitis. The FDA approved ≤3% HP gel as an 
oral debriding agent and an oral wound cleanser. The FDA also cleared the prescription 
tray branded as the Perio Tray® (Perio Protect, St. Louis, MO) as a subgingival delivery 
medical device in 2004 (21 C.F.R. § 872.6870). Customized extensions of the tray 
support the customized seal to direct the gel deep down into the sulcus or periodontal 
pocket and overcome the crevicular fluid flow 22. 
Custom tray application of the HP gel as an adjunct to SRP in the treatment of chronic 
periodontitis has been investigated.  In randomized controlled studies, it was 
demonstrated that significant reduction of probing depth (PD) and bleeding without 
mechanical intervention were seen after two weeks of HP prescription tray regimen 
followed by SRP and the results were maintained for up to six months with the daily use 
of HP prescription trays for 10 weeks 22, 23. The prescription tray delivery of HP gel as an 
adjunctive to SRP was effective before and after full-mouth SRP in reducing PD about 
1mm over SRP alone for six months in chronic periodontitis patients 23, 24. However, 
there is currently no randomized control clinical study evaluating the differences in the 
duration effects of the treatment in chronic periodontitis patients with customized 
delivery of hydrogen peroxide gel. 
The primary objectives of this randomized, controlled, single-blind, parallel clinical study 
are: (1) to examine if the prescription tray delivery of HP gel adjunctive to SRP results in 
a greater clinical improvement than SRP alone over a six-month period; and (2) to 


 
3 
evaluate whether the custom tray delivery of the HP gel can decrease inflammation prior 
to SRP. 
The secondary objective is to compare if there is a difference between the length of 
treatment of adjunctive HP gel (3-months versus 6-months). It is hypothesized that 
adjunctive HP therapy will provide additional clinical benefits in PD reduction, 
attachment gain, and reduction of bleeding on probing (BOP) compared to SRP alone. 
 
Null Hypotheses: 
There is no significant difference between the treatment groups (SRP + HP13 vs. SRP + 
HP26 vs. SRP alone) with regards to reduction in PD.  
There is no significant difference between the treatment groups with regards to 
attachment gain. 
There is no significant difference between the treatment groups with regards to BOP. 
 
 
 
 
 
 
 
 
 


 
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CHAPTER TWO 
MATERIALS AND METHODS 
 
Trial Design 
 
This study is a single-blinded, randomized, controlled, parallel clinical trial. This 
study has been approved by the Institutional Review Board of Loma Linda University. 
This protocol is written in concordance to the CONSORT 2010 statement for improving 
the quality of reports of randomized controlled trials. 
 
Screening and Recruitment of Participants 
 
A study population of sixty qualifying adults was selected by screening from 
patients who were referred to the Graduate Periodontics Clinic at Loma Linda University 
School of Dentistry. All patients received a comprehensive periodontal examination and 
those diagnosed generalized moderate to severe chronic periodontitis 25 showing 
minimum of one site with PD of ≥5 mm and bleeding on probing (BOP) in at least two 
quadrants was considered for subject recruitment.  Patients who met the inclusion and 
exclusion criteria were eligible to participate in the study (see Eligibility and Exclusion 
criteria) and the patients were asked if they were willing to be a subject. Verbal and 
written informed consent were given to the subject outlining the purpose, timeline, as 
well as potential risks and benefits of participation. Once the patient accepted and was 
recruited as a subject they were randomized into groups by a predetermined random 
group assigner (see Randomization: Sequence, Allocation, and Implementation).  
 


 
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Eligibility Criteria 
1) 
Volunteers who can read and sign the Research Information and Consent Form 
2) 
Male and female adults, aged ≥18 years. 
3) 
Presence of twenty or more (at least 2 posterior teeth in contact per quadrant, one 
of which is a molar), natural teeth in good state of repair with scorable surfaces.  
4) 
Show evidence of chronic periodontitis, minimum of one site with PD ≥5mm and 
BOP in at least two quadrants and no mechanical debridement for six months prior to the 
start of the study. 
5) 
Agree to comply with the conditions and schedule of the study, i.e., willing to use 
the assigned products (see Treatment Phase and Standardize Oral Hygiene Instruction) 
according to instructions and be available for appointments. 
6) 
Agree not to have a dental prophylaxis, professional whitening treatment, or any 
other elective, non-emergency dental procedure (other than those provided) at any time 
during the study. 
7) 
Willing to refrain from using mouth rinses and tooth whitening products for the 
duration of the study. 
 
Exclusion Criteria 
1) 
Any systemic conditions or medication intake that can alter periodontal status 
(e.g. uncontrolled diabetes (with <3-month recent HbA1c of >8.5%), anti-seizure 
medication, immunosuppressant, and calcium channel blockers with clinical sign of 
gingival overgrowth. 
2) 
Immune-compromised state. 


 
6 
3) 
Any current heavy smoking habits (>10 cigarettes/day) 
4) 
Any medical condition or history requiring prophylactic antibiotic coverage prior 
to dental treatment. 
5) 
Females who are lactating or pregnant (as determined by medical history) or 
planning to become pregnant for the duration of the study. 
7) 
Physical limitations/restrictions compromising oral hygiene procedures. 
8) 
The presence of significant oral soft tissue pathology and/or lesions associated 
with ill-fitting appliances or restorations. 
9) 
Tooth mobility associated with advanced periodontal disease (e.g. score of >2 
using Miller Classification). 
10) 
Any temporomandibular joint disorders. 
11) 
Grossly carious, orthodontically banded, and third molars will not be included in 
the tooth count. 
12)  
Presence of any significantly tipped, crowded, or largely defective restorations. 
13) 
Any extreme adverse events relating to the use of HP gel (e.g. prolonged tooth 
hypersensitivity or aberrant soft tissue/mucosal reaction) 
All participants were screened and evaluated at Loma Linda University School of 
Dentistry Graduate Periodontics Department. There are three groups of 20 patients, two 
therapy test groups and the control group.  
 
Interventions 
The overall study was divided into three phases consisting of: 1) a therapy phase, 2) a 
treatment phase, and 3) a maintenance phase. 


 
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Therapy Phase 
The therapy phase consisted of establishing baseline periodontal parameters and 
implementation of standardized oral hygiene instructions. All subjects were given verbal 
and visual instructions and demonstrated whether or not they can perform adequate oral 
hygiene with repeated instructional sessions throughout the study (see Fig. 1). Oral 
hygiene instructions (OHI) included use of plaque disclosing agent and proper use of 
indicated oral hygiene aids.  The remaining areas of disclosed plaque assessed the quality 
of oral hygiene. Subjects in the two therapy test groups were given their customized 
prescription tray along with supervised instructions during their first try-in. The therapy 
consisted of initiation of 1.7% HP gel delivered in these customized trays (Perio Protect 
Tray, Perio Protect, LLC, St. Louis, MO, USA) four weeks prior to non-surgical 
periodontal treatment, SRP, at week 0. Subjects were instructed to deliver the gel 2-times 
daily for 15 minutes. These subjects also received calendar journals and will be asked to 
log entries of when they have used their trays. 
 
Treatment Phase 
The treatment phase began with non-surgical periodontal treatment. The two therapy test 
groups will have used their customized application HP gel for four weeks prior to the 
start of treatment. Non-surgical periodontal treatment consisted of 1-, or 2-visit SRP 
using ultrasonic and hand instrumentation with local anesthesia. Surfaces were to be 
deemed clean and debrided when subgingival deposits cannot be tactilely detected and 
the root surface feels smooth to the operator. Re-evaluation of SRP was done 8 weeks 
after the last session of SRP, at week 13. One therapy test group stopped using the HP 


 
8 
therapy at the re-evaluation visit (HP13). Whereas the other test therapy group received 
impressions for a new customized tray to continue application of HP therapy for an 
additional 13 weeks (HP26) to the termination of the study. 
 
Maintenance Phase 
All subjects were recalled 4 weeks after re-evaluation of SRP was done for periodontal 
maintenance and again 3 months later for their final maintenance. In the HP26 group, 
subjects continued to use twice-daily HP gel for 15 minutes until the termination of the 
study, at week 26. Measurements for all subjects, correspondingly, were taken at week 
26. Patients enrolled in the study were maintained with 3-month maintenance intervals 
for the duration of the study (See section Follow Up Care). 
 
Standardized OHI 
Subjects were instructed to brush twice daily (morning and evening) with a dentifrice 
(Crest® Cavity Protection Toothpaste, Procter & Gamble Co., Cincinnati, OH, USA) and 
an adult, single end-tapered bristle toothbrush (Nimbus®Microfine®, Nimbus Dental, 
Los Altos CA). Patients will also perform interdental cleaning with aids including 
standard dental floss, threaded floss (Superfloss®, Oral-B®, Proctor & Gamble, 
Cincinnati OH), and interproximal brushes (Proxabrush®, TePe® USA, Anaheim CA) of 
varying sizes depending on embrasure sizes of the patient. Proper technique for each 
cleaning aid were demonstrated and reiterated at each appointment. Oral hygiene aids 
were dispensed to the patient four weeks prior to initiation of SRP. Patients have agreed 


 
9 
to refrain from the use of any prescription or over-the-counter mouth rinses and tooth 
whitening products. 
 
Non-Surgical Periodontal Therapy 
All subjects received SRP by periodontal residents, either in their 2nd or 3rd year of 
specialty training, without time restriction. SRP was conducted with local anesthesia 
using ultrasonic instruments (Cavitron®, Dentsply® International, York PA) devices and 
hand instruments (Gracey Curettes, Hu-Friedy®, Chicago IL). Supra- and subgingival 
surfaces were determined “clean” when the surfaces felt smooth with the use of a 
periodontal explorer (11/12 After-Five™ Explorer, Hu-Friedy®, Chicago IL). 
Supragingival surfaces were polished with a rubber cup and polish paste. 
 
Custom HP Tray Fabrication 
For subjects enrolled and assigned to the two test therapy groups, impressions of both 
maxillary and mandibular arches were made using polyvinyl siloxane (PVS) (Exafast™ 
NDS, GC America, Alsip IL) on stock plastic impression trays. Heavy viscosity vinyl 
polysiloxane (VPS) (Splash! ®, DenMat®, Lompoc CA) was used to first capture the 
dental arch and tooth surfaces then the resulting impression trays were impregnated with 
low viscosity PVS (Exafast™ injection). The impressions was sent to an FDA-registered 
dental laboratory for fabrication of custom, ethylene-vinyl copolymer trays (Perio-
Trays®).  
For subjects assigned to HP26, a second impression was taken at the re-evaluation 
appointment (Visit 5, Week 13) with the same methods as previously described. Once the 


 
10 
new tray was received from the dental laboratory, the patient was recalled and given the 
new custom tray along with any refills of HP gel. 
 
Custom HP Tray Application 
The principal investigator supervised first use of trays and HP gel and, if needed, 
adjustment were made to trays so that it seated completely and comfortably in the 
subject’s mouth while maintaining an adequate seal. Each subject applied a thin ribbon of 
gel throughout tooth indentations to provide a dosage of ~0.75 gram in each tray using a 
mass scale. Treatment frequency will be fixed throughout the study duration:  
Start of Treatment (Visit 2, Week 0) to 8-weeks following SRP (Visit 5, Week 13): two 
treatments per day, 15 minutes each 
Subjects in the treatment groups documented tooth brushing and the gel tray applications 
in calendar journals for the entire duration of the study. Subject compliance was 
estimated throughout the study by reviewing diaries and by massing gel tubes at each 
visit. Patients were instructed to bring in their treatment tubes to each visit. 
 
Outcomes of Clinical Assessment 
The following clinical assessments were performed throughout the study by the same 
examiner who was blinded to the treatment rendered to the subjects.  
 
Clinical Periodontal Parameters 
When collecting data, the examiner was blinded to treatment groups. Using the same 
PVS (Exafast™ NDS, GC America, Alsip IL) impressions to fabricate stone models 


 
11 
(Microstone, Whipmix Corp., Louisville, KY) a customized stent was fabricated using a 
positive pressure thermoplastic mold device (Biostar® Scan/Biostar® V, Great Lakes 
Orthodontics, New York). This 1-mm thick, semi-rigid stent was used as reference26 for 
the linear measurements using a periodontal probe (15 UNC Color-Coded Probe, Hu-
Friedy, Chicago IL). All the measurement will be at 1 mm increments. Clinical parameter 
measurements was taken at six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-
lingual, mid-lingual, and disto-lingual) of each tooth. Relative gingival recession (R-
REC) was measured from a margin of the stent to the most coronal height of the gingival 
margin. PD was measured as the distance from the gingival margin to the depth of the 
pocket. The probe was held flat against the tooth near the gingival margin and inserted 
into the periodontal pocket in a path that is parallel to the long axis of the tooth and 
advanced using light pressure until slight resistance is felt. Relative attachment level 
(RAL) was measured from a margin of the stent to the bottom of the pocket. 
Bleeding on probing (BOP) was measured with sites that show any bleeding within 30 
seconds of probing and was recorded as a percentage. 
Oral hygiene level was measured by using the Modified Quigley-Hein Plaque Index 
(MQH) 27 with disclosing solution that measures plaque on all teeth except 3rd molars at 4 
surfaces on the buccal and lingual surfaces where: 
 
Score 0 has no plaque 
 
Score 1 has separate flecks of plaque along the cervical margin of the tooth 
 
Score 2 has a ≤1 mm band of plaque at the cervical margin of the tooth 
 
Score 3 has a band of plaque >1 mm but <⅓ of the crown of the tooth 
 
Score 4 has plaque that is covering ≥⅓ but <⅔ of the crown of the tooth. 


 
12 
 
Score 5 has plaque covering ≥⅔ of the crown of the tooth 
Full mouth series of periapical and bitewing radiographs was captured for all patients for 
standard periodontal diagnostic procedure as a part of the comprehensive periodontal 
evaluation. Radiographs of patients that were referred other clinics taken within a year of 
the comprehensive periodontal evaluation was used. 
 
Examiner Reproducibility 
 
Collection of clinical periodontal parameters was repeated in 6 patients for inter-
examiner reproducibility.  This was accomplished by randomly recalling some subjects 
for a second exam during the same session, as scheduling permits. Scoring at least one 
other subject before doing the repeat exam minimized the likelihood of the examiner 
recalling individual scores. Interclass/inter-examiner correlation (ICC) of overall 
variability was calculated and represented as an ICC score (SPSS, IBM Corporation, 
Armonk New York U.S.). 
 
Randomization; Sequence, Allocation, and Implementation 
 
Subjects were assigned randomized identification (ID) numbers during enrollment 
(Visit 1), which will be recorded on all Case Report Forms (CRF) and the Product 
Accountability Log. Immediately following the preliminary clinical parameter recording 
the investigators randomly allocated subjects in a group using a predetermined random 
group assigner (SAS, SAS Institute, Cary NC) based upon subjects’ ID numbers. Each 
subject received non-surgical periodontal therapy (SRP) as indicated in areas with 
increased probing depths.  


 
13 
Follow Up Care 
 
Patients enrolled in the study will be monitored for any changes in their periodontal 
status. If deterioration of periodontal conditions is noted (i.e. PD deepening and losing 
RAL >1.5mm with or without bleeding on probing), re-treatment of sites was 
recommended to the patient. Any sites requiring re-treatment, either non-surgical or 
surgical intervention will be excluded in final study data and will be treated as indicated.  
 
Study Schedule 
A study schedule summary follows for HP group arms: 
 
 
Visit 1: Screening, recruitment, randomization and periodontal consultation was 
completed. PVS impressions were taken for fabrication of both prescription trays and 
customized stents created for clinical measurements if patient accepts and were recruited 
as subjects.  
 
Visit 2, Week 0: Data collected for clinical measurements with custom stents for 
RAL, PD and R-rec (Baseline). Delivery of prescription tray and first supervised 
instructions and placement of the gel for the treatment groups. OHI.  
 
Visit 3, Week 4: 4 weeks after the delivery of the tray and the gel; data collection 
of periodontal parameters with stent, 2 quadrants of SRP, reinforcement of OHI. Inquire 
if subjects had any adverse events with the use of hydrogen peroxide gel  
 
Visit 4, Week 5: No more than 1-week elapsed time since visit 4; SRP of 2 
remaining quadrants, reinforcement of OHI.  


 
14 
 
Visit 5, Week 13: Periodontal re-evaluation 8 weeks after last quadrant of SRP; 
data collection of periodontal parameters with stent, SRP on residual sites with detectable 
calculus, termination of peroxide use in HP13. For subjects enrolled in HP26 , new 
impressions were made for new prescription tray. 
 
(Visit 6, Week 14 [HP26 only]): New prescription tray delivery 
 
Visit 6, Week 17: Periodontal maintenance, reinforcement of OHI. 
 
Visit 7, Week 26: Data collection of periodontal parameters with stent (final 
exam), periodontal maintenance, reinforcement of OHI. 
 
A study schedule summary follows for SRP arm: 
 
Visit 1: Screening, recruitment, and randomization. Data collection of periodontal 
parameters by residents and verified by attending periodontists. PVS impressions will be 
taken for fabricating of customized stents for clinical measurements if patient accept and 
are recruited as subjects.  
 
Visit 2, Week 0: Clinical measurements with stents (Baseline).  
 
Visit 3, Week 4: SRP and OHI 
 
Visit 3, Week 5: Remaining quadrants of SRP, reinforcement of OHI  
 
Visit 4, Week 13: Periodontal re-evaluation 8 weeks after last quadrant of SRP; 
data collection of periodontal parameters with stent, SRP on residual sites with detectable 
calculus, reinforcement of OHI  
 
Visit 5, Week 17: Periodontal maintenance, reinforcement of OHI  
 
Visit 6, Week 26: Data collection of periodontal parameters with stent, 
periodontal maintenance, reinforcement of OHI. 


 
15 
 
 
Figure 1. CONSORT Flow Diagram 
 
 


 
16 
Statistical Analysis 
 
The primary outcome variables are PD reduction, RAL gain, and reduction in BOP. PD data 
was computed to provide a mean score per mouth. Secondary efficacy variables were BOP, 
and MQH.  BOP was computed to provide a mean score per mouth for each clinical 
assessment and were analyzed using repeated measures (ANOVA). Outcome variable data 
analysis consisted of between-treatment and within-treatment (longitudinal) comparisons of 
PD and CAL at all examination time points using parametric procedures. Between-treatment 
and within-treatment comparisons employed baseline data and analysis of covariance 
(ANCOVA) for follow-up data. All comparisons were performed using two-sided 
hypothesis tests, and employed a 0.05 level of significance.  
 
 
 
   
 


 
17 
CHAPTER THREE 
RESULTS 
 
 
There were total 15 subjects who completed the 6-month trial. There were 10 
males with an mean age of 55.6 years and 8 males with an mean age of 51.1 years. There 
was a total of 3 patients in SRP group, 3 patients in HP13 group, and 9 patients in HP26 
group. The mean pocket depth (PD) shown in figure 1 at baseline for SRP group was 3.88 
 0.06 mm (std. error), 4.11  0.06 mm for HP13, and 3.83  0.04 mm for HP26. At the 
4-week examination, PD for SRP group decreased to 3.67  0.06 mm, 4.06  0.06 mm 
with HP13, and 3.55  0.04 mm for HP26. At the re-evaluation examination, PD for SRP 
group was 3.30  0.06mm, 3.43  0.06 mm for HP13, and 3.14  0.04 mm for HP26. The 
final examination, PD were 3.43  0.06 for SRP, 3.40  0.06 mm for HP 13, and 3.23  
0.04 mm for HP26. Repeated measure ANOVA showed significant difference in pocket 
depth among all time points in all treatment groups. In SRP group, no significant 
difference between baseline and 4 weeks in pocket depth and relative attachment level. 


 
18 
Figure 2. Mean PD in each group, SRP, HP13, and HP26. 
 
 
 
 
 
Figure 2 shows the mean relative recession over time. The mean relative recession at 
baseline was 3.28  0.06 mm for SRP, 2.87  0.06mm for HP13, and 3.21  0.03 mm for 
HP13. At 4-weeks, it was 3.35  0.06 mm for SRP, 3.23  0.05 mm for HP13, and 3.15  
0.03 mm for HP26. At re-evaluation it was 3.33  0.06 mm for SRP, 3.27  0.05 mm for 
HP13, and 3.29  0.03 mm for HP26. 


 
19 
Figure 3. Mean R-Rec in each group, SRP, HP13, and HP26. 
 
 
 
 
Figure 3 shows the mean relative attachment level. The mean RAL at baseline 
was 7.16  0.08 mm for SRP, 6.97  0.07 mm for HP13, and 7.04  0.04 mm for HP26. 
At 4-weeks, the RAL was 7.02  0.08 mm for SRP, 7.29  0.07 mm for HP13, and 6.69  
0.05 mm for HP26. At re-evaluation the RAL was 6.63  0.08 mm for SRP, 6.15  0.07 
mm for HP13, and 6.39  0.04 mm for HP26. At the final exam RAL was 6.79  0.08 
mm for SRP, 6.71  0.07 mm for HP13, and 6.53  0.04 mm for HP26. 


 
20 
 
Figure 4. Mean RAL in each group, SRP, HP13, and HP26. 
 
 
 
Figures 4, 5, 6, and 7 show baseline, 4-week, re-evaluation, and final MQH 
plaque scores. Plaque scores varied throughout the four timepoints with no obvious 
differences between groups. 
 
 
 


 
21 
A)
 
B)
 
C)
 
Figure 5. Baseline MQH scores for A) SRP, B) HP13, and C) HP26 


 
22 
A)
 
B)
 
C)
 
Figure 6. 4-Week MQH scores for A) SRP, B) HP13, and C) HP26. 


 
23 
A)
 
B)
 
C)
 
Figure 7. Re-Evaluation MQH scores for A) SRP, B) HP13, and C) HP26. 


 
24 
A)
 
B)
 
C)
 
Figure 8. Final MQH scores for A) SRP, B) HP13, and C) HP26. 
 


 
25 
 
 
Figure 9. Mean BOP in each group, SRP, HP13, and HP26 
 
 
 
Figure 10. BOP % in pockets initially <5 mm 


 
26 
 
Figure 11. BOP % in pockets initially 5mm 
 
 
Figure 8 shows mean BOP. Baseline mean BOP was 45% for SRP, 57% for 
HP13, and 63.1% for HP26. At 4-weeks, mean BOP was 45% for SRP, 60% for HP13, 
and 44% for HP26. At re-evaluation, mean BOP was 37% for SRP, 30% for HP13, and 
27% for HP26. Final mean BOP scores were 44% for SRP, 33% for HP13, and 28% for 
HP13. Mean BOP was significantly reduced in all groups between 4-week examination 
and re-evaluation with mean BOP scores at final examination staying similar to levels at 
re-evaluation for HP13 and HP26 groups. Mean BOP scores at final examination group 
for SRP group was similar to baseline.  
Figure 9 shows BOP % in pockets initially <5mm. At baseline, 24% of pockets 
<5mm were BOP for SRP, 47% for HP13, and 52% for HP26. At 4-week examination 
BOP % were 29% for SRP, 44% for HP13, and 35% for HP26. At re-evaluation, BOP % 


 
27 
was 27% for SRP, 21% for HP13, and 22% for HP26. At the final exam, BOP % was 
33% for SRP, 26% for HP13, and 22% for HP26. 
Figure 10 shows BOP % in pockets initially 5mm. At baseline, BOP % was 92% 
for SRP, 81% for HP13, and 91% for HP26. At 4-week examination, BOP % was 91% 
for SRP, 93% for HP13, and 83% for HP26. Re-evaluation BOP % was 91% for SRP, 
78% for HP13, and 75% for HP26. At final examination, BOP % was 88% for SRP, 79% 
for HP13, and 78% for HP26. 
 
 


 
28 
CHAPTER FOUR 
DISCUSSION 
 
 
This randomized, examiner-blind, parallel-design, clinical trial compared the 
effectiveness of SRP to daily treatment with 1.7% hydrogen peroxide using prescription, 
custom-fabricated dental trays as an adjunct to SRP. The results of this study demonstrate 
that the peroxide/prescription tray treatment regimen in combination with SRP is 
statistically significant in terms of reduction of BoP  
 
In contrast to prior studies (Putt 2012, 2013 Journal of Clinical Dentistry), this 
study did not provide evidence to show that the use of peroxide/prescription tray regimen 
prior to SRP would reduce pocket depths without mechanical intervention. According to 
Putt 2012, the mean difference between test and control group after two weeks of 4-times 
daily use hydrogen peroxide was 0.44 mm in sites >5mm. The difference between test 
and control groups for all sites was 0.18mm. The difference that was seen between our 
study was that the subjects were instructed to use twice daily hydrogen peroxide, 
therefore the total “contact time” of peroxide is effective half. 
 
 
The amount of marginal tissue recession over time did not demonstrate an 
increase of soft tissue recession over time with the use of the prescription trays indicated 
that the physical seal along the gingival margin does not induce or propagate recession. 
 
 
 


 
29 
CHAPTER FIVE 
CONCLUSION 
 
 
In conclusion, the use of adjunctive HP in custom fabricated trays presents with 
no adverse effects. Significant improvement was evident in pocket depth and attachment 
level in both treatment groups between after 4 weeks of using the tray. No significant 
effect found in SRP group between baseline and 4 weeks. After SRP, significant 
difference was seen in all three groups between 4 weeks and 3 months.  
 


 
30 
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