Effect of Disinfective Solution as an Adjunct to Maintenance Therapy of Inflamed Periodontal Pockets
Primary Purpose
Chronic Periodontitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scaling and root planing
Scaling and root planing with solution
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
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
Sites / Locations
- UNMC College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Placebo Comparator
Active Comparator
Arm Label
Healthy sites
Scaling and root planing sites
Scaling and root planing with solution
Arm Description
Healthy sites with no inflammation; observational only
Inflamed pocket receiving mechanical instrumentation
Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution
Outcomes
Primary Outcome Measures
Probing depths
Periodontal probing depth (PD)
Secondary Outcome Measures
Bleeding on probing
Incidence of bleeding during probing
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
Inflammatory markers
Measure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest
Full Information
NCT ID
NCT02316652
First Posted
December 8, 2014
Last Updated
August 22, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT02316652
Brief Title
Effect of Disinfective Solution as an Adjunct to Maintenance Therapy of Inflamed Periodontal Pockets
Official Title
Using Chemical Pocket Disinfection as an Adjunct to Non-surgical Maintenance Therapy of Inflamed Periodontal Pockets
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Study stopped and was not completed
Study Start Date
January 15, 2014 (Actual)
Primary Completion Date
November 22, 2016 (Actual)
Study Completion Date
November 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy sites
Arm Type
No Intervention
Arm Description
Healthy sites with no inflammation; observational only
Arm Title
Scaling and root planing sites
Arm Type
Placebo Comparator
Arm Description
Inflamed pocket receiving mechanical instrumentation
Arm Title
Scaling and root planing with solution
Arm Type
Active Comparator
Arm Description
Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Mechanical instrumentation
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing with solution
Intervention Description
Mechanical instrumentation with sodium hypochlorite disinfective solution
Primary Outcome Measure Information:
Title
Probing depths
Description
Periodontal probing depth (PD)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Bleeding on probing
Description
Incidence of bleeding during probing
Time Frame
3 months
Title
Clinical attachment level
Description
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
Time Frame
3 months
Title
Inflammatory markers
Description
Measure interleukin-1 beta and interleukin 1 receptor antagonist levels in gingival crevicular fluid from sites of interest
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Kaldahl, DDS
Organizational Affiliation
UNMC College of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
UNMC College of Dentistry
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Disinfective Solution as an Adjunct to Maintenance Therapy of Inflamed Periodontal Pockets
We'll reach out to this number within 24 hrs