Alveolar OsteitisPhase 4NCT02382809
Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction
A Phase 4 study testing DC071 in people with Alveolar Osteitis, run by Pierre Fabre Medicament at 18 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- DC071
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Mar 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 13Show fewer
- 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
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
France10 sites
Study site
Bordeaux
Study site
Brest
Study site
Dijon
Study site
Le Petit-Quevilly
Study site
Lyon
Study site
Metz
Study site
Pierre-Bénite
Study site
Saint-Maixent-l'École
Study site
Strasbourg
Study site
Toulouse
Latvia4 sites
Study site
Daugavpils
Study site
Liepāja
Study site
Riga
Study site
Valmiera
About this study
Official title: Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care 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.
- Conditions
- Alveolar Osteitis
- Being tested
- DC071, Placebo
- Keywords
- Alveolar osteitis, Third molar, Dry socket, Mouthwash, third molar extraction
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC071Drug
Mouthwash, twice daily
PlaceboDrug
Mouthwash, twice daily
| Study group | Role | What they receive |
|---|---|---|
| DC071 (0.2% chlorhexidine digluconate) | Experimental | Not described Receives: Drug: DC071 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar OsteitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Françoise TONNER, Study director, Pierre Fabre Medicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382809
- Sponsor's protocol ID
- DC0071 BB 4 05
- Other IDs
- 2014-004682-24, 2014
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction
- ClinicalTrials.gov ID
- NCT02382809
- Acronym / sponsor ID
- DC0071 BB 4 05
- Conditions
- Alveolar Osteitis
- Keywords
- Alveolar osteitis, Third molar, Dry socket, Mouthwash, third molar extraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DC071 (0.2% chlorhexidine digluconate) | Experimental | Drug: DC071 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC071Mouthwash, twice daily | Drug | DC071 (0.2% chlorhexidine digluconate) |
| PlaceboMouthwash, twice daily | Drug | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
Related trials for Alveolar Osteitis
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Not yet recruiting
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
Alveolar Osteitis
Not yet recruiting
Effectiveness of Telephonic and Digital Postoperative Follow-up Communication Strategies on Patient Compliance, Clinical Recovery, and Quality of Life After Dental Extraction
Tooth Extraction, Postoperative Care
RecruitingObservational study
PERIodontal Disease, Microbiota and Miscarriage
Miscarriage, Parodontitis
Active, not recruitingEarly Phase 1
Ozone Oil-based Gel and CHX Gel After Lower Third Molar Removal
Pain, Dry Socket
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise TONNER study director
Pierre Fabre Medicament
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DC071 in people with Alveolar Osteitis, run by Pierre Fabre Medicament at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Latvia, Lithuania, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of an alveolar osteitis (time frame: Within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.