Wisdom Tooth AvulsionAlvéCareNCT02583997
Non-closure of Alveoli After Avulsion of Wisdom Teeth
A study testing Suturing of lower alveoli and Non suturing of lower alveoli in people with Wisdom Tooth Avulsion, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The main objective of this study is to evaluate postoperative pain (measured by visual analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a similar group of patients undergoing standard… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Wisdom Tooth Avulsion
- What is being tested?
- Suturing of lower alveoli and Non suturing of lower alveoli
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Jun 2016to 30 Sep 2018
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient was correctly informed about the implementation of the study, its objectives, constraints and patient rights
- The patient gave his/her free and informed signed consent
- For patients under 18 years of age, the patient's parents (or legal guardian) must have given their free and informed signed consent
- The patient must be affiliated with or the recipient of a health insurance program
- The patient is available for 31 days of follow-up
- The patient is a candidate for avulsion of all 4 wisdom teeth under general anesthesia
Who cannot join
- The patient is participating in another study
- The patient has participated in another study in the last 3 months
- The patient is in an exclusion period is determined by a previous study
- The patient is an adult under guardianship
- The patient is under judicial protection
- The patient refuses to sign the consent
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- It is impossible to correctly inform the patient
- For patients under 18 years of age, his/her parents (or legal guardian) refuse to sign the consent
- The patient is pregnant, breastfeeding or parturient
- The patient has a contra-indication (or an incompatible combination therapy) for a treatment in this study
- The patient is taking antiplatelet agents
- The patient is taking anticoagulants
- The patient has a coagulation disorder
- The patient suffers from immunosuppression
- The patient's wisdom teeth are in a normal, functional, healthy position
- Other orofacial surgical procedures are planned during the study period
- Active pericoronitis
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CH de Perpignan - Hôpital Saint Jean
Perpignan, 66046
About this study
Official title: Non-closure of Alveoli After Avulsion of Wisdom Teeth: a Randomized, Open, Multicenter Trial
The main objective of this study is to evaluate postoperative pain (measured by visual analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a similar group of patients undergoing standard care (suturing for lower alveoli).
Read the detailed description
The secondary objectives of this study are to compare the following between the two study arms:
- Pain at day 31 B. Operative time C. Edema D. Trismus E. The occurrence of complications F. Alveolar flap healing G. The impact of smoking on the occurrence of complications H. The consumption of analgesics and use of local pain remedies I. Impact on quality of life
- Conditions
- Wisdom Tooth Avulsion
- Being tested
- Suturing of lower alveoli, Non suturing of lower alveoli
- Keywords
- To suture or not to suture...., Tooth extraction, Third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing of lower alveoliProcedure or surgery
After extraction of wisdom teeth, the lower alveoli are sutured closed.
Non suturing of lower alveoliProcedure or surgery
After extraction of wisdom teeth, no alveoli are sutured closed.
| Study group | Role | What they receive |
|---|---|---|
| Routine third molar extraction | Active comparator | Patients randomized to this arm will have all four wisdom teeth removed according to usual, standard care (i.e. with suturing of the lower alveoli).
Intervention: Suturing of lower alveoli Receives: Procedure: Suturing of lower alveoli |
| Third molar extraction without suturing | Experimental | Patients randomized to this arm will have all four wisdom teeth removed according to usual, standard care, except that the resulting alveoli will not be sutured.
Intervention: Non suturing of lower alveoli Receives: Procedure: Non suturing of lower alveoli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale for pain.
Surgery is on day 0.
Measured: Day 2
Secondary outcomes (18)
Visual analog scale for pain.
Measured: Day 0
Visual analog scale for pain.
Measured: Day 31
Operative time
From time of first incision to moment when sterile fields are removed.
Measured: Day 0
Edema
((D-Dbaseline)/Dbaseline)*100
Where D =[(the distance from the lobe of the left ear to the left labial commissure)+(the distance from the lobe of the right ear to the right labial commissure)]/2. D is measured in mm. D evaluates edema.
The Dbaseline measure is made just before surgery.
Measured: Day 0: post-op.
Edema
((D-Dbaseline)/Dbaseline)*100
Where D =[(the distance from the lobe of the left ear to the left labial commissure)+(the distance from the lobe of the right ear to the right labial commissure)]/2. D is measured in mm. D evaluates edema.
The Dbaseline measure is made just before surgery.
Measured: Day 2
Edema
((D-Dbaseline)/Dbaseline)*100
Where D =[(the distance from the lobe of the left ear to the left labial commissure)+(the distance from the lobe of the right ear to the right labial commissure)]/2. D is measured in mm. D evaluates edema.
The Dbaseline measure is made just before surgery.
Measured: Day 31
Trismus
((T-Tbaseline)/Tbaseline)*100
Where T = A measure of maximum mouth opening in mm ; T evaluates trismus.
The Tbaseline measure is made just before surgery.
Measured: Day 0: post-op.
Trismus
((T-Tbaseline)/Tbaseline)*100
Where T = A measure of maximum mouth opening in mm ; T evaluates trismus.
The Tbaseline measure is made just before surgery.
Measured: Day 2
Trismus
((T-Tbaseline)/Tbaseline)*100
Where T = A measure of maximum mouth opening in mm ; T evaluates trismus.
The Tbaseline measure is made just before surgery.
Measured: Day 31
The occurrence of complications
The occurrence of at least one complication among the following with at least one of the 4 teeth:
- Hemorrhage: occurrence of continuous or intermittent bleeding from the socket immediately after extraction of the wisdom tooth or later on
- Infection: occurrence of purulent discharge, a collection of pus or cellulitis at the surgical site
- Dry alveolitis: presence of an empty socket with a whitish, atonal bone, giving off a foul odor and very sensitive
- Suppurative alveolitis: presence of granulomatous tissue, bleeding and pus in the socket. The latter are accompanied by pain, trismus, low-grade fever, and regional lymphadenopathy.
Measured: Day 0
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Measured: Day 0
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Measured: Day 2
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Measured: Day 31
The consumption of analgesics
Measured: Day 0
The consumption of analgesics
Measured: Day 2
The consumption of analgesics
Measured: Day 31
The General Oral Health Assessment Index questionnaire
Measured: Day 0
The General Oral Health Assessment Index questionnaire
Measured: Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start2 Jun 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wisdom Tooth AvulsionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Lapeyrie, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583997
- Sponsor's protocol ID
- LOCAL/2014/PL-01
- Other IDs
- 2014-A00512-45
- Acronym
- AlvéCare
- Status last verified
- Aug 2018
- First submitted
- 20 Oct 2015
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Takadoum S, Douilly G, de Boutray M, Kabani S, Maladiere E, Demattei C, Lapeyrie P. Sutureless socket technique after removal of third molars: a multicentric, open, randomized controlled trial. BMC Oral Health. 2022 Jun 26;22(1):256. doi: 10.1186/s12903-022-02287-y.
PubMed 35754043
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-closure of Alveoli After Avulsion of Wisdom Teeth: a Randomized, Open, Multicenter Trial
- ClinicalTrials.gov ID
- NCT02583997
- Acronym / sponsor ID
- AlvéCare / LOCAL/2014/PL-01
- Conditions
- Wisdom Tooth Avulsion
- Keywords
- To suture or not to suture...., Tooth extraction, Third molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 22 Oct 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 main objective of this study is to evaluate postoperative pain (measured by visual analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a similar group of patients undergoing standard care (suturing for lower alveoli).
Detailed description
The secondary objectives of this study are to compare the following between the two study arms:
- Pain at day 31 B. Operative time C. Edema D. Trismus E. The occurrence of complications F. Alveolar flap healing G. The impact of smoking on the occurrence of complications H. The consumption of analgesics and use of local pain remedies I. Impact on quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine third molar extraction | Active comparator | Procedure: Suturing of lower alveoliPatients randomized to this arm will have all four wisdom teeth removed according to usual, standard care (i.e. with suturing of the lower alveoli). Intervention: Suturing of lower alveoli |
| Third molar extraction without suturing | Experimental | Procedure: Non suturing of lower alveoliPatients randomized to this arm will have all four wisdom teeth removed according to usual, standard care, except that the resulting alveoli will not be sutured. Intervention: Non suturing of lower alveoli |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The patient was correctly informed about the implementation of the study, its objectives, constraints and patient rights
- The patient gave his/her free and informed signed consent
- For patients under 18 years of age, the patient's parents (or legal guardian) must have given their free and informed signed consent
- The patient must be affiliated with or the recipient of a health insurance program
- The patient is available for 31 days of follow-up
Key exclusion criteria (17 listed)
- The patient is participating in another study
- The patient has participated in another study in the last 3 months
- The patient is in an exclusion period is determined by a previous study
- The patient is an adult under guardianship
- The patient is under judicial protection
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 |
|---|---|---|
| Suturing of lower alveoliAfter extraction of wisdom teeth, the lower alveoli are sutured closed. | Procedure or surgery | Routine third molar extraction |
| Non suturing of lower alveoliAfter extraction of wisdom teeth, no alveoli are sutured closed. | Procedure or surgery | Third molar extraction without suturing |
Primary outcome
Visual analog scale for pain.
Time frame: Day 2
Surgery is on day 0.
18 secondary outcomes
Visual analog scale for pain.
Time frame: Day 0
Visual analog scale for pain.
Time frame: Day 31
Operative time
Time frame: Day 0
Edema
Time frame: Day 0: post-op.
Edema
Time frame: Day 2
Edema
Time frame: Day 31
Trismus
Time frame: Day 0: post-op.
Trismus
Time frame: Day 2
Trismus
Time frame: Day 31
The occurrence of complications
Time frame: Day 0
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Time frame: Day 0
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Time frame: Day 2
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Time frame: Day 31
The consumption of analgesics
Time frame: Day 0
The consumption of analgesics
Time frame: Day 2
The consumption of analgesics
Time frame: Day 31
The General Oral Health Assessment Index questionnaire
Time frame: Day 0
The General Oral Health Assessment Index questionnaire
Time frame: Day 31
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 21 Nov 2025.
- Results publication: PubMed 35754043Takadoum S, Douilly G, de Boutray M, Kabani S, Maladiere E, Demattei C, Lapeyrie P. Sutureless socket technique after removal of third molars: a multicentric, open, randomized controlled trial. BMC Oral Health. 2022 Jun 26;22(1):256. doi: 10.1186/s12903-022-02287-y.
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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.
Philippe Lapeyrie, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suturing of lower alveoli and Non suturing of lower alveoli in people with Wisdom Tooth Avulsion, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
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 6 inclusion and 17 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Visual analog scale for pain. (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583997, which also lists 1 linked publication.
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 21 Nov 2025.