NCT02382809

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

Geographic Reach
4 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

March 3, 2015

Last Update Submit

March 8, 2016

Conditions

Alveolar Osteitis

Keywords

Alveolar osteitisThird molarDry socketMouthwashthird molar extraction

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 7 days

Study Arms (2)

DC071 (0.2% chlorhexidine digluconate)

EXPERIMENTAL
Drug: DC071

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DC071DRUG

Mouthwash, twice daily

DC071 (0.2% chlorhexidine digluconate)
PlaceboDRUG

Mouthwash, twice daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Tallinn, Estonia

Location

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Brest, France

Location

Unknown Facility

Dijon, France

Location

Unknown Facility

Le Petit-Quevilly, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Metz, France

Location

Unknown Facility

Pierre-Bénite, France

Location

Unknown Facility

Saint-Maixent-l'École, France

Location

Unknown Facility

Strasbourg, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Daugavpils, Latvia

Location

Unknown Facility

Liepāja, Latvia

Location

Unknown Facility

Riga, Latvia

Location

Unknown Facility

Valmiera, Latvia

Location

Unknown Facility

Kaunas, Lithuania

Location

Unknown Facility

Klaipėda, Lithuania

Location

Unknown Facility

Vilnius, Lithuania

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Françoise TONNER

    Pierre Fabre Medicament

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 9, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

LI(3)FR(10)LA(4)ES(1)