Back to resultsClinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery
Primary Purpose
Periodontal Diseases, Periodontitis, Dental Plaque
Status
Unknown status
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Chlorhexidine 0.2%, Corsodyl
Chlorhexidine 0.2%, Curasept
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontal Index
Eligibility Criteria
Inclusion Criteria:
Periodontitis, stage III and IV
Exclusion Criteria:
Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension
Sites / Locations
- Erik MaulandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Chlorhexidine 0.2% mouthwash control
Chlorhexidine 0.2% mouthwash with an Anti Discoloring System
Arm Description
Chlorhexidine 0.2%, Corsodyl Intervention rinsing 60 sec twice daily
Chlorhexidine 0.2%, Curasept Intervention rinsing 60 sec twice daily
Outcomes
Primary Outcome Measures
Plaque index
Dental Plaque
Gingival Index
Gingivitis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04223076
Brief Title
Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery
Official Title
Clinical Performance of Two 0.2% Chlorhexidine Mouth Rinses After Periodontal Surgery. A Blinded, Intra-individual Cross-over Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontitis, Dental Plaque
Keywords
Periodontal Index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Intra individual cross-over, double intervention
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine 0.2% mouthwash control
Arm Type
Experimental
Arm Description
Chlorhexidine 0.2%, Corsodyl Intervention rinsing 60 sec twice daily
Arm Title
Chlorhexidine 0.2% mouthwash with an Anti Discoloring System
Arm Type
Experimental
Arm Description
Chlorhexidine 0.2%, Curasept Intervention rinsing 60 sec twice daily
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine 0.2%, Corsodyl
Intervention Description
Comparison of Corsodyl and Curasept
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine 0.2%, Curasept
Intervention Description
Chlorhexidine 0.2% mouthwash with an Anti Discoloring System (ADS)
Primary Outcome Measure Information:
Title
Plaque index
Description
Dental Plaque
Time Frame
14 days intervention period
Title
Gingival Index
Description
Gingivitis
Time Frame
14 days intervention period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Periodontitis, stage III and IV
Exclusion Criteria:
Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erik Mauland, DDS
Phone
004747636914
Email
erik.mauland@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Preus, Professor
Email
h.r.preus@odont.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Merete Aass, Professor
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
Erik Mauland
City
Oslo
ZIP/Postal Code
0574
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Mauland
Phone
47636914
Email
erik.mauland@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery
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