Clinical trial NCT02583997: Non-closure of Alveoli After Avulsion of Wisdom Teeth
Official title: Non-closure of Alveoli After Avulsion of Wisdom Teeth: a Randomized, Open, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wisdom Tooth Avulsion
Keywords: To suture or not to suture....
Tooth extraction
Third molar
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 care (suturing for lower alveoli).

Detailed description: The secondary objectives of this study are to compare the following between the two study arms:

A. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Visual analog scale for pain.
timeFrame: Day 2
Secondary outcomes:
measure: Visual analog scale for pain.
timeFrame: Day 0
measure: Visual analog scale for pain.
timeFrame: Day 31
measure: Operative time
timeFrame: Day 0
measure: Edema
timeFrame: Day 0: post-op.
measure: Edema
timeFrame: Day 2
measure: Edema
timeFrame: Day 31
measure: Trismus
timeFrame: Day 0: post-op.
measure: Trismus
timeFrame: Day 2
measure: Trismus
timeFrame: Day 31
measure: The occurrence of complications
timeFrame: Day 0
measure: For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
timeFrame: Day 0
measure: For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
timeFrame: Day 2
measure: For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
timeFrame: Day 31
measure: The consumption of analgesics
timeFrame: Day 0
measure: The consumption of analgesics
timeFrame: Day 2
measure: The consumption of analgesics
timeFrame: Day 31
measure: The General Oral Health Assessment Index questionnaire
timeFrame: Day 0
measure: The General Oral Health Assessment Index questionnaire
timeFrame: Day 31
Other outcomes:
measure: Age
timeFrame: Baseline (day 0)
measure: Gender
timeFrame: Baseline (day 0)
measure: Body mass index
timeFrame: Baseline (day 0)
measure: Number of cigarettes smoked per day
timeFrame: Day 0
measure: Number of cigarettes smoked per day
timeFrame: Day 2
measure: Number of cigarettes smoked per day
timeFrame: Day 31
measure: Proximity of the M3 nerve for each tooth
timeFrame: Baseline (day 0)
measure: Winter classification for each tooth
timeFrame: Baseline (day 0)
measure: Delay between surgery and the first post-operative measure (e.g. for edema or trismus)
timeFrame: Day 0
measure: Surgical indication (i.e. why the avulsion is being performed).
timeFrame: Baseline (day 0)
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Gui de Chauliac
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Perpignan
country: France
facility: CH de Perpignan - Hôpital Saint Jean
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Philippe Lapeyrie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.