Effect of Disinfective Solution as an Adjunct to Maintenance Therapy of Inflamed Periodontal Pockets

Study Overview
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Brief Summary
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This study will determine whether the supplemental use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation.

Detailed Description
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The purpose of this study is to determine whether the adjunctive use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation, as indicated by presence of pro- and anti-inflammatory cytokines, compared to scaling and root planing alone. The chemical pocket disinfection therapy consists of delivering a sodium hypochlorite solution followed by a neutralizing citric acid solution to the test site. Pro-inflammatory interleukin-1 beta and anti-inflammatory interleukin-1 receptor antagonist will be measured from the gingival crevicular fluid sampled from sites of interest.

Official Title
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Using Chemical Pocket Disinfection as an Adjunct to Non-surgical Maintenance Therapy of Inflamed Periodontal Pockets

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Scaling and root planing
* Procedure: Scaling and root planing with solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Periodontal maintenance patients, have at least one pocket greater than or equal to 5 mm with bleeding on probing Exclusion Criteria: Uncontrolled diabetics Regular users of nonsteroidal antiinflammatory drugs Individuals on anti-coagulants Individuals that have used antibiotics in the previous 3 months or require prophylactic antibiotic coverage Pregnant individuals

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Healthy sites<br>Healthy sites with no inflammation; observational only | |
| Placebo Comparator: Scaling and root planing sites<br>Inflamed pocket receiving mechanical instrumentation | Procedure: Scaling and root planing<br>* Mechanical instrumentation<br>|
| Active Comparator: Scaling and root planing with solution<br>Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution | Procedure: Scaling and root planing with solution<br>* Mechanical instrumentation with sodium hypochlorite disinfective solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depths | Periodontal probing depth (PD) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing | Incidence of bleeding during probing | 3 months | 
| Clinical attachment level | Clinical attachment level is calculated by adding gingival recession to probing depth; measures the connective tissue and epithelial attachment level relative to the cementoenamel junction | 3 months | 
| Inflammatory markers | Measure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest | 3 months |