Loma Linda, California 92354

  • Periodontitis, Chronic

Purpose:

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.


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


NCT ID:

NCT03262701


Primary Contact:

Principal Investigator
Yoon Jeong Kim, DDS
Loma Linda University

Yoon Jeong Kim, DDS
Phone: 909 558 4610
Email: ykim02d2@llu.edu


Backup Contact:

Email: jokim3@llu.edu
Joseph Kim, DDS
Phone: 909 430 1973


Location Contact:

Loma Linda, California 92354
United States

Yoon Jeong Kim, DDS
Phone: 909-558-4610
Email: ykim02d2@llu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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