Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery

January 8, 2020 updated by: Erik Mauland, University of Oslo

Clinical Performance of Two 0.2% Chlorhexidine Mouth Rinses After Periodontal Surgery. A Blinded, Intra-individual Cross-over Clinical Trial

Chlorhexidine is the gold standard of dental plaque prevention. Recent research have demonstrated that 0.2% Chlorhexidine solutions are more effective than 0.12% and 0.06% Chlorhexidine solutions. Several 0.2% solutions are available on the market. This study aimed to compare effectiveness of two commercially available 0.2% chlorhexidine mouthwashes. Patients, that after initial periodontal therapy, had a need for two periodontal surgeries, will be invited to join. After one surgical session, the patient will receive one 0.2% chlorhexidine solution, and after the next surgical session the patient will receive the other 0.2% chlorhexidine solution. Plaque and gingivitis will be recorded, as well as side effects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Periodontitis, stage III and IV

Exclusion Criteria:

Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorhexidine 0.2% mouthwash control
Chlorhexidine 0.2%, Corsodyl Intervention rinsing 60 sec twice daily
Drug: Chlorhexidine 0.2%, Corsodyl
Comparison of Corsodyl and Curasept
Experimental: Chlorhexidine 0.2% mouthwash with an Anti Discoloring System
Chlorhexidine 0.2%, Curasept Intervention rinsing 60 sec twice daily
Drug: Chlorhexidine 0.2%, Curasept
Chlorhexidine 0.2% mouthwash with an Anti Discoloring System (ADS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: 14 days intervention period
Dental Plaque
14 days intervention period
Gingival Index
Time Frame: 14 days intervention period
Gingivitis
14 days intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Investigators

  • Study Chair: Anne Merete Aass, Professor, University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/121314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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