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

Primary Purpose

Wisdom Tooth Avulsion

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Suturing of lower alveoli
Non suturing of lower alveoli
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wisdom Tooth Avulsion focused on measuring To suture or not to suture...., Tooth extraction, Third molar

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHRU de Montpellier - Hôpital Gui de Chauliac
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • CH de Perpignan - Hôpital Saint Jean

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine third molar extraction

Third molar extraction without suturing

Arm 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

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

Outcomes

Primary Outcome Measures

Visual analog scale for pain.
Surgery is on day 0.

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2015
Last Updated
August 2, 2018
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02583997
Brief Title
Non-closure of Alveoli After Avulsion of Wisdom Teeth
Acronym
AlvéCare
Official Title
Non-closure of Alveoli After Avulsion of Wisdom Teeth: a Randomized, Open, Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wisdom Tooth Avulsion
Keywords
To suture or not to suture...., Tooth extraction, Third molar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine third molar extraction
Arm Type
Active Comparator
Arm 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
Arm Title
Third molar extraction without suturing
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Suturing of lower alveoli
Intervention Description
After extraction of wisdom teeth, the lower alveoli are sutured closed.
Intervention Type
Procedure
Intervention Name(s)
Non suturing of lower alveoli
Intervention Description
After extraction of wisdom teeth, no alveoli are sutured closed.
Primary Outcome Measure Information:
Title
Visual analog scale for pain.
Description
Surgery is on day 0.
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Visual analog scale for pain.
Time Frame
Day 0
Title
Visual analog scale for pain.
Time Frame
Day 31
Title
Operative time
Description
From time of first incision to moment when sterile fields are removed.
Time Frame
Day 0
Title
Edema
Description
((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.
Time Frame
Day 0: post-op.
Title
Edema
Description
((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.
Time Frame
Day 2
Title
Edema
Description
((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.
Time Frame
Day 31
Title
Trismus
Description
((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.
Time Frame
Day 0: post-op.
Title
Trismus
Description
((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.
Time Frame
Day 2
Title
Trismus
Description
((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.
Time Frame
Day 31
Title
The occurrence of complications
Description
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.
Time Frame
Day 0
Title
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Time Frame
Day 0
Title
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Time Frame
Day 2
Title
For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).
Time Frame
Day 31
Title
The consumption of analgesics
Time Frame
Day 0
Title
The consumption of analgesics
Time Frame
Day 2
Title
The consumption of analgesics
Time Frame
Day 31
Title
The General Oral Health Assessment Index questionnaire
Time Frame
Day 0
Title
The General Oral Health Assessment Index questionnaire
Time Frame
Day 31
Other Pre-specified Outcome Measures:
Title
Age
Time Frame
Baseline (day 0)
Title
Gender
Time Frame
Baseline (day 0)
Title
Body mass index
Time Frame
Baseline (day 0)
Title
Number of cigarettes smoked per day
Time Frame
Day 0
Title
Number of cigarettes smoked per day
Time Frame
Day 2
Title
Number of cigarettes smoked per day
Time Frame
Day 31
Title
Proximity of the M3 nerve for each tooth
Time Frame
Baseline (day 0)
Title
Winter classification for each tooth
Time Frame
Baseline (day 0)
Title
Delay between surgery and the first post-operative measure (e.g. for edema or trismus)
Time Frame
Day 0
Title
Surgical indication (i.e. why the avulsion is being performed).
Time Frame
Baseline (day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Lapeyrie, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Montpellier - Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
CH de Perpignan - Hôpital Saint Jean
City
Perpignan
ZIP/Postal Code
66046
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35754043
Citation
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.
Results Reference
derived

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Non-closure of Alveoli After Avulsion of Wisdom Teeth

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