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Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223076
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Erik Mauland, University of Oslo

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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Periodontitis Dental Plaque Drug: Chlorhexidine 0.2%, Corsodyl Drug: Chlorhexidine 0.2%, Curasept Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Intra individual cross-over, double intervention
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Performance of Two 0.2% Chlorhexidine Mouth Rinses After Periodontal Surgery. A Blinded, Intra-individual Cross-over Clinical Trial
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 30, 2020


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)




Primary Outcome Measures :
  1. Plaque index [ Time Frame: 14 days intervention period ]
    Dental Plaque

  2. Gingival Index [ Time Frame: 14 days intervention period ]
    Gingivitis



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Periodontitis, stage III and IV

Exclusion Criteria:

Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223076


Contacts
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Contact: Erik Mauland, DDS 004747636914 erik.mauland@hotmail.com
Contact: Hans Preus, Professor h.r.preus@odont.uio.no

Locations
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Norway
Erik Mauland Recruiting
Oslo, Norway, 0574
Contact: Erik Mauland    47636914    erik.mauland@hotmail.com   
Sponsors and Collaborators
University of Oslo
Investigators
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Study Chair: Anne Merete Aass, Professor University of Oslo

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Responsible Party: Erik Mauland, DDS, University of Oslo
ClinicalTrials.gov Identifier: NCT04223076    
Other Study ID Numbers: 2020/121314
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Keywords provided by Erik Mauland, University of Oslo:
Periodontal Index
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Dental Plaque
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents