Non-closure of Alveoli After Avulsion of Wisdom Teeth

Not Applicable

Completed

• Conditions: Wisdom Tooth Avulsion
• Interventions: Procedure: Non suturing of lower alveoli; Procedure: Suturing of lower alveoli

• Registration Number: NCT02583997
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Study Start: 2016-06-02
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Third molar extraction without suturing	Non suturing of lower alveoli	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
Routine third molar extraction	Suturing of lower alveoli	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

Primary Outcome Measures

Name	Time	Method
Visual analog scale for pain.	Day 2	Surgery is on day 0.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

CHRU de Montpellier - Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

CH de Perpignan - Hôpital Saint Jean; 🇫🇷 Perpignan, France