NCT02583997

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

June 2, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

November 21, 2025

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

October 20, 2015

Last Update Submit

November 18, 2025

Conditions

Wisdom Tooth Avulsion

Keywords

To suture or not to suture....Tooth extractionThird molar

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale for pain.

    Surgery is on day 0.

    Day 2

Secondary Outcomes (18)

  • Visual analog scale for pain.

    Day 0

  • Visual analog scale for pain.

    Day 31

  • Operative time

    Day 0

  • Edema

    Day 0: post-op.

  • Edema

    Day 2

  • +13 more secondary outcomes

Other Outcomes (10)

  • Age

    Baseline (day 0)

  • Gender

    Baseline (day 0)

  • Body mass index

    Baseline (day 0)

  • +7 more other outcomes

Study Arms (2)

Routine third molar extraction

ACTIVE COMPARATOR

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

Third molar extraction without suturing

EXPERIMENTAL

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

Interventions

Suturing of lower alveoliPROCEDURE

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

Routine third molar extraction
Non suturing of lower alveoliPROCEDURE

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

Third molar extraction without suturing

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another study
  • The patient has participated in another study in the last 3 months
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU de Montpellier - Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CH de Perpignan - Hôpital Saint Jean

Perpignan, 66046, France

Location

Related Publications (1)

  • 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.

    PMID: 35754043RESULT

Study Officials

  • Philippe Lapeyrie, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 22, 2015

Study Start

June 2, 2016

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 21, 2025

Record last verified: 2018-08

Locations

FR(3)