Adjunctive Hydrogen Peroxide for Periodontal Therapy (AHP)

Custom Tray Application of Peroxide Gel as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis: A 6-Month Randomized Trial

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.

Study Overview

• Status: Terminated
• Conditions: Periodontitis, Chronic
• Intervention / Treatment: Drug: Hydrogen Peroxide Gel, 13 weeks; Drug: Hydrogen Peroxide Gel, 26 weeks; Other: Scaling and Root planing group

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrogen Peroxide gel for 13weeks; 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.	Drug: Hydrogen Peroxide Gel, 13 weeks; 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.; Other Names: Perio Protect®; 1.7% hydrogen peroxide gel
Experimental: Hydrogen Peroxide gel for 26weeks; 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.	Drug: Hydrogen Peroxide Gel, 26 weeks; 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.; Other Names: Perio Protect®; 1.7% hydrogen peroxide gel
Other: Scaling and Root Planing; 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.	Other: Scaling and Root planing group; 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; Other Names: SRP group control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal Pocket Depth Reduction	Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.	Change between baseline and Week 4
Periodontal Pocket Depth Reduction	Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.	Change between baseline and Week 13
Periodontal Pocket Depth Reduction	Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.	Change between baseline and Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Attachment Level	Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.	Change between baseline and Week 26
Change in Bleeding on Probing	Change in bleeding on probing measured by the presence of bleeding upon probing a periodontal pocket using a periodontal probe within 30 seconds measured in percentage.	Change between baseline and Week 26

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Yoon Jeong Kim, DDS, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): February 8, 2021

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: 5180025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No