Status:
TERMINATED
Adjunctive Hydrogen Peroxide for Periodontal Therapy
Lead Sponsor:
Loma Linda University
Conditions:
Periodontitis, Chronic
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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...
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 ty...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03262701
Start Date
April 2 2018
End Date
February 8 2021
Last Update
December 21 2022
Active Locations (1)
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1
Loma Linda University Health
Loma Linda, California, United States, 92354