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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: Scaling and root planing; Procedure: Scaling and root planing with solution

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68583
      • UNMC College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy sites; Healthy sites with no inflammation; observational only
Placebo Comparator: Scaling and root planing sites; Inflamed pocket receiving mechanical instrumentation	Procedure: Scaling and root planing; Mechanical instrumentation
Active Comparator: Scaling and root planing with solution; Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution	Procedure: Scaling and root planing with solution; Mechanical instrumentation with sodium hypochlorite disinfective solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depths	Periodontal probing depth (PD)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Inflammatory markers	Measure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest	3 months
Bleeding on probing	Incidence of bleeding during probing	3 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Study Director: Wayne Kaldahl, DDS, UNMC College of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2014
• Primary Completion (Actual): November 22, 2016
• Study Completion (Actual): November 22, 2016

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimated): December 15, 2014

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Chronic Disease; Periodontitis; Chronic Periodontitis; Periodontal Pocket
• Other Study ID Numbers: 0636-13-FB