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Adjunctive Hydrogen Peroxide for Periodontal Therapy

NCT ID: NCT03262701

Last Updated: 2022-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2021-02-08

Brief Summary

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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

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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.

Conditions

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Periodontitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Hydrogen Peroxide Gel, 13 weeks

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Hydrogen Peroxide Gel, 26 weeks

Intervention Type DRUG

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.

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.

Group Type OTHER

Scaling and Root planing group

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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Perio Protect® 1.7% hydrogen peroxide gel Perio Protect® 1.7% hydrogen peroxide gel SRP group control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoon Jeong Kim, DDS

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

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Loma Linda University Health

Loma Linda, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5180025

Identifier Type: -

Identifier Source: org_study_id