Non-closure of Alveoli After Avulsion of Wisdom Teeth (AlvéCare)

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).

Study Overview

• Status: Completed
• Conditions: Wisdom Tooth Avulsion
• Intervention / Treatment: Procedure: Suturing of lower alveoli; Procedure: Non suturing of 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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Gui de Chauliac
  • Nîmes Cedex 9, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • Perpignan, France, 66046
    • CH de Perpignan - Hôpital Saint Jean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine third molar extraction; 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	Procedure: Suturing of lower alveoli; After extraction of wisdom teeth, the lower alveoli are sutured closed.
Experimental: Third molar extraction without suturing; 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	Procedure: Non suturing of lower alveoli; After extraction of wisdom teeth, no alveoli are sutured closed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale for pain.	Surgery is on day 0.	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale for pain.		Day 0
Visual analog scale for pain.		Day 31
Operative time	From time of first incision to moment when sterile fields are removed.	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.	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.	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.	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.	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.	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.	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.	Day 0
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).		Day 0
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).		Day 2
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).		Day 31
The consumption of analgesics		Day 0
The consumption of analgesics		Day 2
The consumption of analgesics		Day 31
The General Oral Health Assessment Index questionnaire		Day 0
The General Oral Health Assessment Index questionnaire		Day 31

Other Outcome Measures

Outcome Measure	Time Frame
Age	Baseline (day 0)
Body mass index	Baseline (day 0)
Gender	Baseline (day 0)
Number of cigarettes smoked per day	Day 0
Number of cigarettes smoked per day	Day 2
Number of cigarettes smoked per day	Day 31
Proximity of the M3 nerve for each tooth	Baseline (day 0)
Winter classification for each tooth	Baseline (day 0)
Delay between surgery and the first post-operative measure (e.g. for edema or trismus)	Day 0
Surgical indication (i.e. why the avulsion is being performed).	Baseline (day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Philippe Lapeyrie, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2016
• Primary Completion (Actual): July 26, 2018
• Study Completion (Actual): July 26, 2018

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Third molar; Tooth extraction; To suture or not to suture....
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Fractures, Avulsion; Tooth Avulsion
• Other Study ID Numbers: LOCAL/2014/PL-01; 2014-A00512-45 (Other Identifier: RCB number)