Periodontitis, ChronicPhase 4AHPNCT03262701
Adjunctive Hydrogen Peroxide for Periodontal Therapy
A Phase 4 study testing Hydrogen Peroxide Gel, 13 weeks, Hydrogen Peroxide Gel, 26 weeks and Scaling and Root planing group in people with Periodontitis, Chronic, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Chronic
- What is being tested?
- Hydrogen Peroxide Gel, 13 weeks, Hydrogen Peroxide Gel, 26 weeks and Scaling and Root planing group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 8 Feb 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92354
About this study
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
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.
Read the 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.
- Conditions
- Periodontitis, Chronic
- Being tested
- Hydrogen Peroxide Gel, 13 weeks, Hydrogen Peroxide Gel, 26 weeks, Scaling and Root planing group
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen Peroxide Gel, 13 weeksDrug
Also called Perio Protect®, 1.7% hydrogen peroxide gel
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, 26 weeksDrug
Also called Perio Protect®, 1.7% hydrogen peroxide gel
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 groupOther
Also called SRP group control
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Scaling and Root planing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change between baseline and Week 26
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change between baseline and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start2 Apr 2018
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Periodontitis, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoon Jeong Kim, DDS, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262701
- Sponsor's protocol ID
- 5180025
- Acronym
- AHP
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2017
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03262701
- Acronym / sponsor ID
- AHP / 5180025
- Conditions
- Periodontitis, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 21 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrogen Peroxide gel for 13weeks | Experimental | Drug: Hydrogen Peroxide Gel, 13 weeksSubjects 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. |
| Hydrogen Peroxide gel for 26weeks | Experimental | Drug: Hydrogen Peroxide Gel, 26 weeksSubjects 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. |
| Scaling and Root Planing | Other | Other: Scaling and Root planing groupSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen Peroxide Gel, 13 weeksAlso: Perio Protect®, 1.7% hydrogen peroxide gel13 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. | Drug | Hydrogen Peroxide gel for 13weeks |
| Hydrogen Peroxide Gel, 26 weeksAlso: Perio Protect®, 1.7% hydrogen peroxide gel26 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. | Drug | Hydrogen Peroxide gel for 26weeks |
| Scaling and Root planing groupAlso: SRP group controlSubjects 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 | Scaling and Root Planing |
Primary outcome
Periodontal Pocket Depth Reduction
Time frame: Change between baseline and Week 4
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
Time frame: Change between baseline and Week 13
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
Time frame: Change between baseline and Week 26
Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
2 secondary outcomes
Change in Clinical Attachment Level
Time frame: Change between baseline and Week 26
Change in Bleeding on Probing
Time frame: Change between baseline and Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon Jeong Kim, DDS principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrogen Peroxide Gel, 13 weeks, Hydrogen Peroxide Gel, 26 weeks and Scaling and Root planing group in people with Periodontitis, Chronic, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Pocket Depth Reduction (time frame: Change between baseline and Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.