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

University of Nebraska

Status: Terminated

Conditions: Chronic Periodontitis

Treatments: Procedure: Scaling and root planing with solution; Procedure: Scaling and root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT02316652

0636-13-FB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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33 participants in 3 patient groups, including a placebo group

Healthy sites

No Intervention group

Description:

Healthy sites with no inflammation; observational only

Scaling and root planing sites

Placebo Comparator group

Description:

Inflamed pocket receiving mechanical instrumentation

Treatment:

Procedure: Scaling and root planing

Scaling and root planing with solution

Active Comparator group

Description:

Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution

Treatment:

Procedure: Scaling and root planing with solution