Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatments scaling and root planing, scaling and root planing with solution
Sponsor University of Nebraska
Start date October 2013
End date May 2015
Trial size 33 participants
Trial identifier NCT02316652, 636-13-FB

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(No Intervention)
Healthy sites with no inflammation; observational only
(Placebo Comparator)
Inflamed pocket receiving mechanical instrumentation
scaling and root planing
Mechanical instrumentation
(Active Comparator)
Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution
scaling and root planing with solution
Mechanical instrumentation with sodium hypochlorite disinfective solution

Primary Outcomes

Measure
Probing depths
time frame: 3 months

Secondary Outcomes

Measure
Bleeding on probing
time frame: 3 months
Clinical attachment level
time frame: 3 months
Inflammatory markers
time frame: 3 months

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title Using Chemical Pocket Disinfection as an Adjunct to Non-surgical Maintenance Therapy of Inflamed Periodontal Pockets
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Nebraska.