Back to results

Adjunctive Hydrogen Peroxide for Periodontal Therapy (AHP)

Primary Purpose

Periodontitis, Chronic

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Hydrogen Peroxide Gel, 13 weeks

Hydrogen Peroxide Gel, 26 weeks

Scaling and Root planing group

About this trial

This is an interventional treatment trial for Periodontitis, Chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Loma Linda University Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Hydrogen Peroxide gel for 13weeks

Hydrogen Peroxide gel for 26weeks

Scaling and Root Planing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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 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.

Full Information

NCT ID

NCT03262701

First Posted

August 22, 2017

Last Updated

November 29, 2022

Sponsor

Loma Linda University

1. Study Identification

Unique Protocol Identification Number

NCT03262701

Brief Title

Adjunctive Hydrogen Peroxide for Periodontal Therapy

Acronym

AHP

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

COVID

Study Start Date

April 2, 2018 (Actual)

Primary Completion Date

February 8, 2021 (Actual)

Study Completion Date

February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrogen Peroxide gel for 13weeks

Arm Type

Experimental

Arm Description

Arm Title

Hydrogen Peroxide gel for 26weeks

Arm Type

Experimental

Arm Description

Arm Title

Scaling and Root Planing

Arm Type

Other

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Hydrogen Peroxide Gel, 13 weeks

Other Intervention Name(s)

Perio Protect®, 1.7% hydrogen peroxide gel

Intervention Description

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

Intervention Name(s)

Hydrogen Peroxide Gel, 26 weeks

Other Intervention Name(s)

Perio Protect®, 1.7% hydrogen peroxide gel

Intervention Description

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

Other

Intervention Name(s)

Scaling and Root planing group

Other Intervention Name(s)

SRP group control

Intervention Description

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

Primary Outcome Measure Information:

Title

Periodontal Pocket Depth Reduction

Description

Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.

Time Frame

Change between baseline and Week 4

Title

Periodontal Pocket Depth Reduction

Description

Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.

Time Frame

Change between baseline and Week 13

Title

Periodontal Pocket Depth Reduction

Description

Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.

Time Frame

Change between baseline and Week 26

Secondary Outcome Measure Information:

Title

Change in Clinical Attachment Level

Description

Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.

Time Frame

Change between baseline and Week 26

Title

Change in Bleeding on Probing

Description

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.

Time Frame

Change between baseline and Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoon Jeong Kim, DDS

Organizational Affiliation

Loma Linda University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loma Linda University Health

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Adjunctive Hydrogen Peroxide for Periodontal Therapy

We'll reach out to this number within 24 hrs