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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02316652
• Other study ID #: 0636-13-FB
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2014
• Est. completion date: November 22, 2016

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: November 22, 2016
• Est. primary completion date: November 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontal Pocket
• Periodontitis

Intervention

Procedure:
• Scaling and root planing
Mechanical instrumentation
• Scaling and root planing with solution
Mechanical instrumentation with sodium hypochlorite disinfective solution

Locations

Country	Name	City	State
United States	UNMC College of Dentistry	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depths	Periodontal probing depth (PD)	3 months
Secondary	Bleeding on probing	Incidence of bleeding during probing	3 months
Secondary	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
Secondary	Inflammatory markers	Measure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest	3 months