Non-closure of Alveoli After Avulsion of Wisdom Teeth

Centre Hospitalier Universitaire de Nīmes100 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Wisdom Tooth Avulsion

Interventions

Suturing of lower alveoliPROCEDURE

After extraction of wisdom teeth, the lower alveoli are sutured closed.

Non suturing of lower alveoliPROCEDURE

After extraction of wisdom teeth, no alveoli are sutured closed.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Locations (3)

CHRU de Montpellier - Hôpital Gui de Chauliac

Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

CH de Perpignan - Hôpital Saint Jean

Perpignan, France

Outcomes

Primary Outcomes

Visual analog scale for pain.

Surgery is on day 0.

Time frame: Day 2

Secondary Outcomes

Visual analog scale for pain.

Time frame: Day 0

Visual analog scale for pain.

Time frame: Day 31

Operative time

From time of first incision to moment when sterile fields are removed.

Time frame: 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.

Time frame: Day 0: post-op.

Edema

Time frame: Day 2

Edema

Time frame: 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.

Data from ClinicalTrials.gov

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