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

NCT02316652 | Terminated

• 1 other identifier: 0636-13-FB
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Probing depths

  Periodontal probing depth (PD)

  3 months

Secondary Outcomes (3)

• Bleeding on probing

  3 months

• Clinical attachment level

  3 months

• Inflammatory markers

  3 months

Study Arms (3)

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

Scaling and root planing PROCEDURE

Mechanical instrumentation

Scaling and root planing sites

Scaling and root planing with solution PROCEDURE

Mechanical instrumentation with sodium hypochlorite disinfective solution

Scaling and root planing with solution

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontal maintenance patients, have at least one pocket greater than or equal to 5 mm with bleeding on probing

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

UNMC College of Dentistry

Lincoln, Nebraska, 68583, United States

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Solutions

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Pharmaceutical Preparations

Study Officials

• Wayne Kaldahl, DDS

  UNMC College of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 15, 2014
• Study Start: January 15, 2014
• Primary Completion: November 22, 2016
• Study Completion: November 22, 2016
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

US (1)