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OpenTrials
Completed

NCT Number: NCT02382809

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tallinn, Estonia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DC071

Drug

Mouthwash, twice daily

Placebo

Drug

Mouthwash, twice daily

Primary outcomes

  1. Occurrence of an alveolar osteitis

    Time frame: Within 7 days

    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.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2015
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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