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Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction

Primary Purpose

Alveolar Osteitis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
DC071
Placebo
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alveolar Osteitis focused on measuring Alveolar osteitis, Third molar, Dry socket, Mouthwash, third molar extraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female over 18 years old
  • Subject needing to undergo extraction of one impacted mandibular third molar
  • For woman of childbearing potential and woman in post menopausal period under hormonal substitution treatment, she must accept to plan the extraction of the impacted mandibular third molar only during the last week of the menstrual cycle.
  • Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation)

Exclusion Criteria:

  • Existence or history of parotid gland disorders
  • Acute or history of recent acute pericoronitis at any tooth
  • Extraction of more than 1 third molar in the same surgical procedure
  • Subject at high risk of bacterial endocarditis (prosthetic heart valve, history of bacterial endocarditis, congenital cyanogenic heart disease)
  • Coagulation or haemostatic disorder or use of anticoagulants
  • Hypersensitivity to chlorhexidine or any of the excipients;
  • Hypersensitivity to any anesthetic agent;
  • Hypersensitivity to corticosteroids, analgesics including opioid drugs used for post-surgery pain relief
  • Intake of systemic vasodilator or vasoconstrictor
  • Intake of systemic or local (in the mouth) antibiotics within 7 days before Day 1 and/or any pre- or post-operative antibiotic prophylaxis planned to be prescribed during the study;
  • Use of any antiseptic mouthwash within 7 days before Day -1
  • Regular heavy smokers (more than 20 cigarettes per day)
  • Is pregnant or in post-partum period or a nursing mother

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DC071 (0.2% chlorhexidine digluconate)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of an alveolar osteitis
The primary Outcome measure will be evaluated based on the absence/presence of an alveolar osteitis within 7 days after the extraction of the third molar.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2015
Last Updated
March 8, 2016
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT02382809
Brief Title
Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction
Official Title
Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction and to evaluate the safety and local tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Osteitis
Keywords
Alveolar osteitis, Third molar, Dry socket, Mouthwash, third molar extraction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DC071 (0.2% chlorhexidine digluconate)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DC071
Intervention Description
Mouthwash, twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Mouthwash, twice daily
Primary Outcome Measure Information:
Title
Occurrence of an alveolar osteitis
Description
The primary Outcome measure will be evaluated based on the absence/presence of an alveolar osteitis within 7 days after the extraction of the third molar.
Time Frame
Within 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female over 18 years old Subject needing to undergo extraction of one impacted mandibular third molar For woman of childbearing potential and woman in post menopausal period under hormonal substitution treatment, she must accept to plan the extraction of the impacted mandibular third molar only during the last week of the menstrual cycle. Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation) Exclusion Criteria: Existence or history of parotid gland disorders Acute or history of recent acute pericoronitis at any tooth Extraction of more than 1 third molar in the same surgical procedure Subject at high risk of bacterial endocarditis (prosthetic heart valve, history of bacterial endocarditis, congenital cyanogenic heart disease) Coagulation or haemostatic disorder or use of anticoagulants Hypersensitivity to chlorhexidine or any of the excipients; Hypersensitivity to any anesthetic agent; Hypersensitivity to corticosteroids, analgesics including opioid drugs used for post-surgery pain relief Intake of systemic vasodilator or vasoconstrictor Intake of systemic or local (in the mouth) antibiotics within 7 days before Day 1 and/or any pre- or post-operative antibiotic prophylaxis planned to be prescribed during the study; Use of any antiseptic mouthwash within 7 days before Day -1 Regular heavy smokers (more than 20 cigarettes per day) Is pregnant or in post-partum period or a nursing mother
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise TONNER
Organizational Affiliation
Pierre Fabre Medicament
Official's Role
Study Director
Facility Information:
City
Tallinn
Country
Estonia
City
Bordeaux
Country
France
City
Brest
Country
France
City
Dijon
Country
France
City
Lyon
Country
France
City
Metz
Country
France
City
Petit quevilly
Country
France
City
Pierre Benite
Country
France
City
Saint Maixent l'Ecole
Country
France
City
Strasbourg
Country
France
City
Toulouse
Country
France
City
Dauga Vpils
Country
Latvia
City
Liepaja
Country
Latvia
City
Riga
Country
Latvia
City
Valmiera
Country
Latvia
City
Kaunas
Country
Lithuania
City
Klaipeda
Country
Lithuania
City
Vilnius
Country
Lithuania

12. IPD Sharing Statement

Learn more about this trial

Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction

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