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

Not Applicable

Terminated

• Conditions: Chronic Periodontitis
• Interventions: Procedure: Scaling and root planing with solution; Procedure: Scaling and root planing

• Registration Number: NCT02316652
• Lead Sponsor: University of Nebraska

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01-15
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Primary Completion: 2016-11-22
• Study Completion: 2016-11-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scaling and root planing with solution	Scaling and root planing with solution	Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution
Scaling and root planing sites	Scaling and root planing	Inflamed pocket receiving mechanical instrumentation

Primary Outcome Measures

Name	Time	Method
Probing depths	3 months	Periodontal probing depth (PD)

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	3 months	Measure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest
Bleeding on probing	3 months	Incidence of bleeding during probing
Clinical attachment level	3 months	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

Trial Locations

Locations (1)

UNMC College of Dentistry; 🇺🇸 Lincoln, Nebraska, United States