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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02382809

Enrollment

414

Registered

2015-03-09

Start date

2015-03-31

Completion date

2016-02-29

Last updated

2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Osteitis

Keywords

Alveolar osteitis, Third molar, Dry socket, Mouthwash, third molar extraction

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.

Interventions

DRUGDC071

Mouthwash, twice daily

DRUGPlacebo

Mouthwash, twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of an alveolar osteitis	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.

Countries

Estonia, France, Latvia, Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026