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CompletedNCT02382809Updated Mar 9, 2016

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

A Phase 4 interventional study of DC071 and Placebo in Alveolar Osteitis, sponsored by Pierre Fabre Medicament. Completed at 18 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-09.

Sponsored by Pierre Fabre Medicament (part of Pierre Fabre) · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
414
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alveolar Osteitis

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Keywords

  • Alveolar osteitis
  • Third molar
  • Dry socket
  • Mouthwash
  • third molar extraction
03

In context

Dry Socket

41 studies on the registry are indexed under Dry Socket; 10 are open to participants now.

This study's enrollment of 414 is above the median of 60 across 36 interventional studies indexed under Dry Socket.

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Lead sponsor

Pierre Fabre Medicament is the lead sponsor of 73 studies on the registry; 6 are open to participants now.

Browse Pierre Fabre Medicament studies →All Pierre Fabre studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
414 participants (actual)

Study arms

  • Experimental
    DC071 (0.2% chlorhexidine digluconate)

    Drug: DC071

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugDC071

    Mouthwash, twice daily

  • DrugPlacebo

    Mouthwash, twice daily

06

What researchers measure

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.

    Time frame: Within 7 days

07

Study locations

18 sites
  • Tallinn, Estonia
  • Bordeaux, France
  • Brest, France
  • Dijon, France
  • Le Petit-Quevilly, France
  • Lyon, France
  • Metz, France
  • Pierre-Bénite, France
  • Saint-Maixent-l'École, France
  • Strasbourg, France
  • Toulouse, France
  • Daugavpils, Latvia
  • Liepāja, Latvia
  • Riga, Latvia
  • Valmiera, Latvia
  • Kaunas, Lithuania
  • Klaipėda, Lithuania
  • Vilnius, Lithuania
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2015, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2015
First posted
Mar 9, 2015
Start
Mar 2015
Primary completionActual
Feb 2016
CompletionActual
Feb 2016
Last update
Mar 9, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02382809
Lead sponsor
Pierre Fabre Medicament
Responsible party
Sponsor
First posted
Mar 9, 2015
Start date
Mar 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Mar 9, 2016

Study contacts

Françoise TONNER
study director · Pierre Fabre Medicament
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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