Periodontitis, Chronic
Conditions
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.
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 type in 1.7% as an adjunct to conventional periodontal therapy has been introduced but there are limited information on the efficacy. The current study is to design to evaluate the adjunctive treatment outcome of hydrogen peroxide gel in custom tray application in individuals with chronic periodontitis receiving non surgical therapy, scaling and root planing(SRP). To test the adjunct effect of HP gel in tray, there will be three parallel arms, one with the gel for the period of 26 week, one with the gel for 13 weeks and control group without the gel.
Interventions
DRUGHydrogen 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.
DRUGHydrogen 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.
OTHERScaling 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
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Pocket Depth Reduction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level | 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. |
| Change in Bleeding on Probing | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydrogen Peroxide Gel for 13weeks 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.
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. | 14 |
| Hydrogen Peroxide Gel for 26weeks 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.
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. | 17 |
| 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.
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 | 8 |
| Total | 39 |
Baseline characteristics
| Characteristic | Hydrogen Peroxide Gel for 13weeks | Hydrogen Peroxide Gel for 26weeks | Scaling and Root Planing | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 6 Participants | 33 Participants |
| Age, Continuous | 48.3 years STANDARD_DEVIATION 13.5 | 54.5 years STANDARD_DEVIATION 15.4 | 57.1 years STANDARD_DEVIATION 15.7 | 52.7 years STANDARD_DEVIATION 14.8 |
| Bleeding On Probing | 57.1 percent STANDARD_DEVIATION 37.2 | 66.9 percent STANDARD_DEVIATION 11.9 | 35.2 percent STANDARD_DEVIATION 16.8 | 53.1 percent STANDARD_DEVIATION 22.9 |
| Pocket Depth | 4.11 millimeters STANDARD_DEVIATION 1.43 | 3.41 millimeters STANDARD_DEVIATION 1.16 | 3.82 millimeters STANDARD_DEVIATION 1.29 | 3.78 millimeters STANDARD_DEVIATION 1.29 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 14 Participants | 17 Participants | 8 Participants | 39 Participants |
| Relative Attachment Level | 6.97 millimeters STANDARD_DEVIATION 1.29 | 7.11 millimeters STANDARD_DEVIATION 0.83 | 6.75 millimeters STANDARD_DEVIATION 0.16 | 6.94 millimeters STANDARD_DEVIATION 0.76 |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 4 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 4 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 17 | 0 / 8 |
| other Total, other adverse events | 0 / 14 | 0 / 17 | 0 / 8 |
| serious Total, serious adverse events | 0 / 14 | 0 / 17 | 0 / 8 |
Outcome results
Primary
Periodontal Pocket Depth Reduction
Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
Time frame: Change between baseline and Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrogen Peroxide Gel for 13weeks | Periodontal Pocket Depth Reduction | -0.05 millimeters | Standard Deviation 0.16 |
| Hydrogen Peroxide Gel for 26weeks | Periodontal Pocket Depth Reduction | -0.16 millimeters | Standard Deviation 0.05 |
| Scaling and Root Planing | Periodontal Pocket Depth Reduction | 0.05 millimeters | Standard Deviation 0.09 |
Primary
Periodontal Pocket Depth Reduction
Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
Time frame: Change between baseline and Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrogen Peroxide Gel for 13weeks | Periodontal Pocket Depth Reduction | -0.69 millimeters | Standard Deviation 0.31 |
| Hydrogen Peroxide Gel for 26weeks | Periodontal Pocket Depth Reduction | -0.54 millimeters | Standard Deviation 0.33 |
| Scaling and Root Planing | Periodontal Pocket Depth Reduction | -0.34 millimeters | Standard Deviation 0.09 |
Primary
Periodontal Pocket Depth Reduction
Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
Time frame: Change between baseline and Week 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrogen Peroxide Gel for 13weeks | Periodontal Pocket Depth Reduction | -0.70 millimeters | Standard Deviation 0.33 |
| Hydrogen Peroxide Gel for 26weeks | Periodontal Pocket Depth Reduction | -0.49 millimeters | Standard Deviation 0.21 |
| Scaling and Root Planing | Periodontal Pocket Depth Reduction | -0.30 millimeters | Standard Deviation 0.14 |
Secondary
Change in Bleeding on Probing
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.
Time frame: Change between baseline and Week 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrogen Peroxide Gel for 13weeks | Change in Bleeding on Probing | -24.1 percent | Standard Deviation 23.2 |
| Hydrogen Peroxide Gel for 26weeks | Change in Bleeding on Probing | -34.2 percent | Standard Deviation 5.95 |
| Scaling and Root Planing | Change in Bleeding on Probing | -14.2 percent | Standard Deviation 10 |
Secondary
Change in Clinical Attachment Level
Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.
Time frame: Change between baseline and Week 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrogen Peroxide Gel for 13weeks | Change in Clinical Attachment Level | -0.25 millimeters | Standard Deviation 0.65 |
| Hydrogen Peroxide Gel for 26weeks | Change in Clinical Attachment Level | -0.42 millimeters | Standard Deviation 0.13 |
| Scaling and Root Planing | Change in Clinical Attachment Level | -0.23 millimeters | Standard Deviation 0.16 |