Adjunctive Hydrogen Peroxide for Periodontal Therapy
Condition: Periodontitis, Chronic
MeSH terms: Periodontitis; Chronic Periodontitis
Intervention: Hydrogen Peroxide Gel, 13 weeks; Hydrogen Peroxide Gel, 26 weeks; Scaling and Root planing group
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.; 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.; 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
Intervention MeSH terms: Hydrogen Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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 Bleeding
             on Probing (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