Effect of Disinfective Solution as an Adjunct to Maintena... | NCT02316652

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

NCT02316652

Sponsor

University of Nebraska

Status

Terminated

Last Update Posted

Aug 24, 2023Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Chronic Periodontitis

Interventions

Scaling and root planing
Scaling and root planing with solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study stopped and was not completed

Expanded Access Info

Start Date

Jan 15, 2014Actual

Primary Completion Date

Nov 22, 2016Actual

Completion Date

Nov 22, 2016Actual

First Submitted Date

Dec 8, 2014

First Submission Date that Met QC Criteria

Dec 10, 2014

First Posted Date

Dec 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2023

Last Update Posted Date

Aug 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy sites	No Intervention	Healthy sites with no inflammation; observational only
Scaling and root planing sites	Placebo Comparator	Inflamed pocket receiving mechanical instrumentation	Procedure: Scaling and root planing
Scaling and root planing with solution	Active Comparator	Inflamed pocket receiving mechanical instrumentation with sodium hypochlorite solution	Procedure: Scaling and root planing with solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Scaling and root planing	Procedure	Mechanical instrumentation	Scaling and root planing sites

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Bleeding on probing	Incidence of bleeding during probing	3 months
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wayne Kaldahl, DDS	UNMC College of Dentistry	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNMC College of Dentistry		Lincoln	Nebraska	68583	United States

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014080	Tooth Exfoliation
D016745	Root Planing
D012996	Solutions

Ancestor Terms

ID	Term
D009063	Dental Physiological Phenomena
D055688	Digestive System and Oral Physiological Phenomena
D012534	Dental Scaling
D003777	Dental Prophylaxis

Browse Leaves

Not provided

Browse Branches

Not provided