Adjunctive Hydrogen Peroxide for Periodontal Therapy



Status:Recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 80
Updated:4/17/2018
Start Date:April 2, 2018
End Date:June 2019
Contact:Yoon Jeong Kim, DDS
Email:ykim02d2@llu.edu
Phone:909 558 4610

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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.


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
We found this trial at
1
site
Loma Linda, California 92354
Phone: 909-558-4610
?
mi
from
Loma Linda, CA
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