Non-closure of Alveoli After Avulsion of Wisdom Teeth

NCT ID: NCT02583997

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-02
• Study Completion Date: 2018-09-30

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

Conditions

Wisdom Tooth Avulsion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Suturing of lower alveoli

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Non suturing of lower alveoli

Intervention Type: PROCEDURE

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

Interventions

Suturing of lower alveoli

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

Intervention Type: PROCEDURE

Non suturing of lower alveoli

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Lapeyrie, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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

Countries

France

References

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.

Reference Type: RESULT

PMID: 35754043 (View on PubMed)

Other Identifiers

2014-A00512-45

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2014/PL-01

Identifier Type: -

Identifier Source: org_study_id