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Adjunctive Hydrogen Peroxide for Periodontal Therapy (AHP)

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ClinicalTrials.gov Identifier: NCT03262701
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Yoon Jeong Kim, DDS, MS, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Periodontitis, Chronic Drug: Hydrogen Peroxide Gel, 13 weeks Drug: Hydrogen Peroxide Gel, 26 weeks Other: Scaling and Root planing group Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HP13
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: HP26
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

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 Name: SRP group control




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change in clinical attachment level [ Time Frame: Change between baseline and Week 26 ]
    Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.

  2. Change in bleeding on probing [ Time Frame: Change between baseline and Week 26 ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262701


Contacts
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Contact: Yoon Jeong Kim, DDS 909 558 4610 ykim02d2@llu.edu
Contact: Joseph Kim, DDS 909 430 1973 jokim3@llu.edu

Locations
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United States, California
Loma Linda University Health Recruiting
Loma Linda, California, United States, 92354
Contact: Yoon Jeong Kim, DDS    909-558-4610 ext 44610    ykim02d2@llu.edu   
Contact: Joseph Kim, DDS    909 430 1973    jokim3@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Yoon Jeong Kim, DDS Loma Linda University

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Responsible Party: Yoon Jeong Kim, DDS, MS, Associate Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03262701     History of Changes
Other Study ID Numbers: 5180025
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

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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

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents