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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Wisdom Tooth Avulsion

Treatments: Procedure: Suturing of lower alveoli; Procedure: Non suturing of lower alveoli

Study type: Interventional

Funder types: Other

Identifiers

NCT02583997

2014-A00512-45 (Other Identifier)

LOCAL/2014/PL-01

Details and patient eligibility

About

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).

Full 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

Enrollment: 100 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Routine third molar extraction

Active Comparator group

Description:

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

Treatment:

Procedure: Suturing of lower alveoli

Third molar extraction without suturing

Experimental group

Description:

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

Treatment:

Procedure: Non suturing of lower alveoli