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NCT Number: NCT02583997

Non-closure of Alveoli After Avulsion of Wisdom Teeth

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).

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Key information

Conditions

Wisdom Tooth Avulsion

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Montpellier - Hôpital Gui de Chauliac, Montpellier, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suturing of lower alveoli

Procedure

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

Non suturing of lower alveoli

Procedure

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

Primary outcomes

  1. Visual analog scale for pain.

    Time frame: Day 2

    Surgery is on day 0.

Secondary outcomes

  1. Visual analog scale for pain.

    Time frame: Day 0

  2. Visual analog scale for pain.

    Time frame: Day 31

  3. Operative time

    Time frame: Day 0

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

  4. Edema

    Time frame: Day 0: post-op.

    ((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.

  5. Edema

    Time frame: Day 2

    ((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.

  6. Edema

    Time frame: 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.

  7. Trismus

    Time frame: Day 0: post-op.

    ((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.

  8. Trismus

    Time frame: Day 2

    ((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.

  9. Trismus

    Time frame: 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.

  10. The occurrence of complications

    Time frame: 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.

  11. For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).

    Time frame: Day 0

  12. For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).

    Time frame: Day 2

  13. For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).

    Time frame: Day 31

  14. The consumption of analgesics

    Time frame: Day 0

  15. The consumption of analgesics

    Time frame: Day 2

  16. The consumption of analgesics

    Time frame: Day 31

  17. The General Oral Health Assessment Index questionnaire

    Time frame: Day 0

  18. The General Oral Health Assessment Index questionnaire

    Time frame: Day 31

Other outcomes

  1. Age

    Time frame: Baseline (day 0)

  2. Gender

    Time frame: Baseline (day 0)

  3. Body mass index

    Time frame: Baseline (day 0)

  4. Number of cigarettes smoked per day

    Time frame: Day 0

  5. Number of cigarettes smoked per day

    Time frame: Day 2

  6. Number of cigarettes smoked per day

    Time frame: Day 31

  7. Proximity of the M3 nerve for each tooth

    Time frame: Baseline (day 0)

  8. Winter classification for each tooth

    Time frame: Baseline (day 0)

  9. Delay between surgery and the first post-operative measure (e.g. for edema or trismus)

    Time frame: Day 0

  10. Surgical indication (i.e. why the avulsion is being performed).

    Time frame: Baseline (day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Non-closure of Alveoli After Avulsion of Wisdom Teeth: a Randomized, Open, Multicenter Trial

Acronym: AlvéCare

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2015
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.