Adjunctive Hydrogen Peroxide for Periodontal Therapy

NCT03262701 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 5180025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Chronic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Clinical Attachment Level

  Change between baseline and Week 26

• Change in Bleeding on Probing

  Change between baseline and Week 26

Study Arms (3)

Hydrogen Peroxide gel for 13weeks

EXPERIMENTAL

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

Hydrogen Peroxide gel for 26weeks

EXPERIMENTAL

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

Scaling and Root Planing

OTHER

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

Interventions

Hydrogen Peroxide Gel, 13 weeks 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.

Also known as: Perio Protect®, 1.7% hydrogen peroxide gel

Hydrogen Peroxide gel for 13weeks

Hydrogen Peroxide Gel, 26 weeks 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.

Also known as: Perio Protect®, 1.7% hydrogen peroxide gel

Hydrogen Peroxide gel for 26weeks

Scaling and Root planing group 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

Also known as: SRP group control

Scaling and Root Planing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers who can read and sign the Research Information and Consent Form
• Male and female adults, aged ≥18 years.
• 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.
• 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.
• 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.
• 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.
• Willing to refrain from using mouth rinses and tooth whitening products for the duration of the study.

You may not qualify if:

• 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)
• Immune-compromised state.
• Any current heavy smoking habits (\>10 cigarettes/day)
• Any medical condition or history requiring prophylactic antibiotic coverage prior to dental treatment.
• Females who are lactating or pregnant (as determined by medical history) or planning to become pregnant for the duration of the study.
• Physical limitations/restrictions compromising oral hygiene procedures.
• The presence of significant oral soft tissue pathology and/or lesions associated with ill-fitting appliances or restorations.
• Tooth mobility associated with advanced periodontal disease (e.g. score of \>2 using Miller Classification).
• Any temporomandibular joint disorders.
• Grossly carious, orthodontically banded, and third molars will not be included in the tooth count.
• The presence of any significantly tipped, crowded, or largely defective restorations.
• Any extreme adverse events relating to the use of hydrogen peroxide gel (e.g. prolonged

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Limitations and Caveats

Due to COVID lockdown, the enrollment and study discontinued abruptly.

Results Point of Contact

• Title: Yoon Jeong Kim
• Organization: Loma Linda University School of Dentistry

yjkim02d2@llu.edu

(909) 558-4610

Study Officials

• Yoon Jeong Kim, DDS

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 25, 2017
• Study Start: April 2, 2018
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Locations

US (1)