The Effects of Non -Surgical Periodontal Therapy on Glycemic Control and Periodontal Health in Diabetic Patients With Periodontitis (Randomized Controlled Clinical Trial)
Phase: PHASE4
Conditions: Chronic Periodontitis, Generalized
Sponsor: Taibah University

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The Effects of Non –Surgical Periodontal Therapy on Glycemic 
Control and Periodontal Health in Diabetic Patients with 
Periodontitis (Randomized Controlled Clinical Trial) 
 
NCT03783845 
Document Date: December,11,2018 
 
Research Protocol 
 
Principal investigators’ name 
(including position, affiliation, ID 
and contact details) 
Yasser Mohamed El makaky 
Associated professor, Taibah University, KSA 
Assistant professor ,Tanta University, Egypt 
ymkaky@taibahu.edu.sa 
yassermakaky@yahoo.com 
0547048493 
Co-investigators name(s) 
(including position, affiliation, ID 
and contact details) 
None 
Supervisor(s) name  
(if applicable) 
(including position, affiliation, ID 
and contact information) 
None 
Proposed School/ Discipline 
Taibah University 
Tanta University 
 
1. Project/ research title 
The Effects of Non –Surgical Periodontal Therapy on Glycemic Control and Periodontal 
Health in Diabetic Patients with Periodontitis (Randomized Controlled Clinical Trial) 
 

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2. Project/ Research Summary 
 
The aim of the present study is to monitor the clinical outcomes and the metabolic 
response of non-surgical periodontal therapy in patients with chronic periodontitis and 
uncontrolled type 2 diabetes. 
Regarding clinical and metabolic parameters at baseline, no differences will be displayed 
between two groups. However, at 3-months follow-up period the patients within a test 
group  will demonstrate better clinical outcomes than patients in a control group 
 
 
3. Project/ Research details 
 
3.1. 
Introductory background 
 
The relationship between chronic periodontitis and diabetes has been the aim of the 
most intensive research [1]. Many studies suggested the concept of a two-way 
relationship between both diseases [2]. Type 2 diabetic( T2DM) patients show a higher 
extent, severity, and prevalence of chronic periodontitis than healthy subjects [3]. 
Accordingly, T2DM is considered a risk factor for chronic periodontitis [4]. Simpson et al 
.,(2010) observed that the deterioration of glycemic control attributed to chronic 
periodontitis over time[5]. Periodontal therapy can decrease local inflammation, the 
systemic entry of pro-inflammatory molecules and bacterial by-products such as 
lipopolysaccharides [2]. Simpson et al .,(2015) reported that many researches have 
studied the relationship between glycemic control and periodontal therapy (non-surgical 
modality) in the diabetic population and have demonstrated contradictory findings[6]. 
Several clinical trials recommended that more studies are necessary to clarify this link 
([7]; [5]; [8]. Therefore, the aim of this clinical trial is to study the influence of non-surgical 
periodontal therapy on the glycemic level among T2DM patients with chronic 
periodontitis. 

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3.2. 
Research questions 
Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic 
patients with chronic periodontitis? 
Null hypothesis is the non-surgical periodontal therapy doesn’t improve glycemic 
control in type 2 diabetic patients with chronic periodontitis 
 
3.3. 
Aims/Objectives of the project 
The objective of the current clinical study is to evaluate the clinical and the metabolic 
effects of non-surgical periodontal therapy in patients with chronic periodontitis and 
uncontrolled type 2 diabetes. 
 
3.4. 
Significant/Contribution to the discipline 
In the present three- month controlled clinical study, an important aspect is a creation of 
an optimal non-surgical periodontal therapy (NSPT) (consist of OHI, SRP, combination 
of antibiotics, and antiseptics), versus no active therapy in control group, to enhance the 
probability of detection any impact of periodontal therapy on the HbA1C level. In the field, 
this maximization is unique because previous clinical trials either provided potentially 
effective periodontal therapy for control groups such as study of Engebretson et al., 
(2013) who stressed on oral hygiene instructions for control patients[9] or provided sub-
optimal periodontal therapy such as study by Gay et al., (2014) who studied the impact 
of periodontal treatment composed of OHI and SRP alone[10]. 
In diabetic patients the data on the influence of periodontal treatment on metabolic 
control are contradictory. Some publications have reported that NSPT may improve 

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metabolic control [11], [5], [12], [13], [14]. However, in these patients, other studies 
cannot demonstrate significant improvement of glycemic control[7], [15], [16], [17], [6]. 
 
 
3.5. 
Theoretical framework and methods/approach 
Methodology (The methodology, design, and materials, sample and sampling technique, description 
of study tools to be used). 
 
A prospective, randomized controlled clinical trial will be conducted on two parallel 
groups with three months follow-up period. A convenient sample of 44 patients aged 40-
70 will be recruited. 
Test group (patients will give immediate periodontal therapy) 
Control group (patients will give delayed periodontal therapy) 
The subjects with uncontrolled type 2 diabetes (HbA1c from 7% to 9%) will be selected 
from attendants of Internal Medicine Outpatients Clinic, Tanta University Hospital and 
will be referred to Periodontology Department, Tanta University. 
Closed envelopes technique will be used for random allocation of the study participants 
that identify to which group the subjects will be enrolled, using 1:1 allocation ratio. All 
patients will sign informed consent  
 
Inclusion criteria 
- 
Diagnosis of diabetes type 2 for more than five years 
- 
Type 2 diabetes with HbA1c  level from 7% to 9% at the last medical evaluation 
- 
Age from 40 to 70 years 
- 
No change of diabetes treatment over the previous three months 
- 
Diagnosis with chronic periodontitis  
- 
Minimum  sixth permanent  teeth excluding third molars 
- 
Clinical attachment level (CAL) and pocket depth (PD) ≥4 mm in more than thirty 
percent of the sites 
Exclusion criteria 
- 
Pregnancy 
- 
Alcoholism and smoking 
- 
Presence of any systemic disorders other than hypertension and diabetes 

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- 
Diabetic major complications 
- 
Antimicrobial therapies in the last 6 months  
- 
Periodontal therapies in the last 6 months  
- 
Allergy to metronidazole and amoxicillin  
Intervention protocol 
Periodontal therapy will include scaling and root planing (SRP), combination of systemic 
antibiotics[metronidazole 400 mg three times daily for two weeks and amoxicillin 500mg 
three times daily for two weeks ] and  oral hygiene instructions (OHI). Full-mouth SRP 
will be performed by the same specialist for all patients in a test group using ultrasonic 
apparatus and Gracey curettes in a single two-hour session. Local anesthesia will be 
applied when needed. SRP will be associated with subgingival irrigation by chlorhexidine 
0.12% mouthwash. Immediately, after SRP, the administration of antibiotics combination 
will be started and patients will receive a free dental care products necessary for 
periodontal maintenance during a follow-up period (three months). For the patients within 
a control group delayed periodontal therapy will be performed using the same 
procedures that will be applied for the patients in a test group exactly after the end of 
follow up period (three months) because of ethical reasons. Therefore, within the control 
group, no periodontal therapies will be done during the follow-up. 
Clinical and metabolic follow-up 
A complete medical history, socio-demographic data, and information regarding daily 
dental care will be collected for all patients. Charting for the full-mouth periodontium 
using a periodontal probe will be performed by the same specialist. This includes PD, 
CAL, bleeding on probing and the visible dental plaque. The periodontal evaluation will 
be done at baseline and at three months. Blood will take from a peripheral vein to monitor 
HbA1c using high-performance liquid chromatography at baseline and at three months 
post-treatment. 
 
 
Data analysis (The proposed method of data analysis) 

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Data will be coded, collected and analyzed using the SPSS software under Mac OS Majave 
Version 10.14. Descriptive statistics will be done using mean and standard deviations, followed 
by inferential statistics using the Fisher’s exact test, Chi-Square test, student t- test and paired t-
test. Significance was adopted at p<0.05 which will be used as a cutoff point to control for alpha 
error.  
 
3.6. 
References  
1. 
Monsarrat, P., et al., Clinical research activity in periodontal medicine: a systematic mapping of 
trial registers. Journal of clinical periodontology, 2016. 43(5): p. 390-400. 
2. 
Taylor, J.J., P.M. Preshaw, and E. Lalla, A review of the evidence for pathogenic mechanisms 
that may link periodontitis and diabetes. Journal of Periodontology, 2013. 84(4-s): p. S113-
S134. 
3. 
Chávarry, N.G.M., et al., The relationship between diabetes mellitus and destructive periodontal 
disease: a meta-analysis. Oral health & preventive dentistry, 2009. 7(2). 
4. 
Jimenez, M., et al., Type 2 diabetes mellitus and 20 year incidence of periodontitis and tooth 
loss. Diabetes research and clinical practice, 2012. 98(3): p. 494-500. 
5. 
Simpson, T.C., et al., Treatment of periodontal disease for glycaemic control in people with 
diabetes. Australian Dental Journal, 2010. 55(4): p. 472-474. 
6. 
Simpson, T.C., et al., Treatment of periodontal disease for glycaemic control in people with 
diabetes mellitus. Cochrane Database of Systematic Reviews, 2015(11). 
7. 
Janket, S.-J., et al., Does periodontal treatment improve glycemic control in diabetic patients? A 
meta-analysis of intervention studies. Journal of dental research, 2005. 84(12): p. 1154-1159. 
8. 
Teshome, A. and A. Yitayeh, The effect of periodontal therapy on glycemic control and fasting 
plasma glucose level in type 2 diabetic patients: systematic review and meta-analysis. BMC oral 
health, 2017. 17(1): p. 31. 
9. 
Engebretson, S.P., et al., The effect of nonsurgical periodontal therapy on hemoglobin A1c levels 
in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. Jama, 
2013. 310(23): p. 2523-2532. 
10. 
Gay, I.C., et al., The effect of periodontal therapy on glycaemic control in a H ispanic population 
with type 2 diabetes: a randomized controlled trial. Journal of clinical periodontology, 2014. 
41(7): p. 673-680. 
11. 
Madden, T.E., et al., Alterations in HbA1c following minimal or enhanced non-surgical, non-
antibiotic treatment of gingivitis or mild periodontitis in type 2 diabetic patients: a pilot trial. J 
Contemp Dent Pract, 2008. 9(5): p. 9-16. 
12. 
Teeuw, W.J., V.E. Gerdes, and B.G. Loos, Effect of periodontal treatment on glycemic control of 
diabetic patients: a systematic review and meta-analysis. Diabetes care, 2010. 33(2): p. 421-
427. 

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13. 
Koromantzos, P.A., et al., A randomized, controlled trial on the effect of non‐surgical 
periodontal therapy in patients with type 2 diabetes. Part I: effect on periodontal status and 
glycaemic control. Journal of clinical periodontology, 2011. 38(2): p. 142-147. 
14. 
Sgolastra, F., et al., Effectiveness of periodontal treatment to improve metabolic control in 
patients with chronic periodontitis and type 2 diabetes: a meta‐analysis of randomized clinical 
trials. Journal of periodontology, 2013. 84(7): p. 958-973. 
15. 
Jones, J.A., et al., Does periodontal care improve glycemic control? The department of veterans 
affairs dental diabetes study. Journal of clinical periodontology, 2007. 34(1): p. 46-52. 
16. 
Correa, F.O., et al., Effect of periodontal treatment on metabolic control, systemic inflammation 
and cytokines in patients with type 2 diabetes. Journal of clinical periodontology, 2010. 37(1): p. 
53-58. 
17. 
Santos, V., et al., Partial‐and full‐mouth scaling and root planing in type 2 diabetic subjects: a 
12‐mo follow‐up of clinical parameters and levels of cytokines and osteoclastogenesis‐related 
factors. Journal of periodontal research, 2012. 47(1): p. 45-54. 
 
 
3.7. Project/ research management 
This section includes a discussion on  
Ethical consideration  
(if applicable) 
(include 
confidential/ 
sensitive 
information 
or 
intellectual 
property 
information) 
This study will be submitted for review to Taibah 
University College of Dentistry Research Ethics 
Committee (TUCDREC). 
 
In the case of requesting a 
waiver of documentation 
of consent form; Please 
justify. 
No waiving of documentation of informed consent form 
will be requested, a copy of the consent form is 
attached with this application 
Potential Risk or problems 
& safety consideration 
There is no risk to the patients and all collocated data 
will be anonymous. 

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Benefits of participating in 
the study 
All patients in both groups will be received non-surgical 
periodontal therapy that will improve their periodontal 
status. 
The present study will support or contradict previous 
studies which have reported the relations between the 
periodontal therapy and the glycemic control. 
 
Project plan 
(including 
other 
required 
administrative 
approvals, 
fieldwork 
information, 
facilities, timeframe, cost & 
budget 
justification, 
resources, health & safety 
considerations) 
The follow-up period in this study will be 3 months 
 
 

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