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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-15

Study Completion Date

2016-11-22

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.

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Healthy sites

Healthy sites with no inflammation; observational only

Group Type NO_INTERVENTION

No interventions assigned to this group

Scaling and root planing sites

Inflamed pocket receiving mechanical instrumentation

Group Type PLACEBO_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

Mechanical instrumentation

Scaling and root planing with solution

Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution

Group Type ACTIVE_COMPARATOR

Scaling and root planing with solution

Intervention Type PROCEDURE

Mechanical instrumentation with sodium hypochlorite disinfective solution

Interventions

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Scaling and root planing

Mechanical instrumentation

Intervention Type PROCEDURE

Scaling and root planing with solution

Mechanical instrumentation with sodium hypochlorite disinfective solution

Intervention Type PROCEDURE

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes