Clinical trial NCT03262701: Adjunctive Hydrogen Peroxide for Periodontal Therapy
Official title: Custom Tray Application of Peroxide Gel as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis: A 6-Month Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Periodontitis, Chronic
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Volunteers who can read and sign the Research Information and Consent Form
2. Male and female adults, aged ≥18 years.
3. The presence of twenty or more (at least 2 posterior teeth in contact per quadrant, one of which is a molar), natural teeth in a good state of repair with scorable surfaces.
4. Show evidence of chronic periodontitis, minimum of one site with PD ≥5mm and Bleeding on Probing (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 and immunosuppressants, and calcium channel blockers with clinical evidence of drug-influenced gingival enlargement)
2. Immune-compromised state.
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.
6. Physical limitations/restrictions compromising oral hygiene procedures.
7. The presence of significant oral soft tissue pathology and/or lesions associated with ill-fitting appliances or restorations.
8. Tooth mobility associated with advanced periodontal disease (e.g. score of \>2 using Miller Classification).
9. Any temporomandibular joint disorders.
10. Grossly carious, orthodontically banded, and third molars will not be included in the tooth count.
11. The presence of any significantly tipped, crowded, or largely defective restorations.
12. Any extreme adverse events relating to the use of hydrogen peroxide gel (e.g. prolonged

Primary outcomes:
measure: Periodontal Pocket Depth Reduction
timeFrame: Change between baseline and Week 4
measure: Periodontal Pocket Depth Reduction
timeFrame: Change between baseline and Week 13
measure: Periodontal Pocket Depth Reduction
timeFrame: Change between baseline and Week 26
Secondary outcomes:
measure: Change in Clinical Attachment Level
timeFrame: Change between baseline and Week 26
measure: Change in Bleeding on Probing
timeFrame: Change between baseline and Week 26
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University
name: Yoon Jeong Kim, DDS
role: PRINCIPAL_INVESTIGATOR
References: