Wisdom Tooth Avulsion Clinical Trial
— AlvéCareOfficial title:
Non-closure of Alveoli After Avulsion of Wisdom Teeth: a Randomized, Open, Multicenter Trial
| Verified date | August 2018 |
| Source | Centre Hospitalier Universitaire de Nimes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | July 26, 2018 |
| Est. primary completion date | July 26, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 14 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU de Montpellier - Hôpital Gui de Chauliac | Montpellier | |
| France | CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 9 | |
| France | CH de Perpignan - Hôpital Saint Jean | Perpignan |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Age | Baseline (day 0) | ||
| Other | Gender | Baseline (day 0) | ||
| Other | Body mass index | Baseline (day 0) | ||
| Other | Number of cigarettes smoked per day | Day 0 | ||
| Other | Number of cigarettes smoked per day | Day 2 | ||
| Other | Number of cigarettes smoked per day | Day 31 | ||
| Other | Proximity of the M3 nerve for each tooth | Baseline (day 0) | ||
| Other | Winter classification for each tooth | Baseline (day 0) | ||
| Other | Delay between surgery and the first post-operative measure (e.g. for edema or trismus) | Day 0 | ||
| Other | Surgical indication (i.e. why the avulsion is being performed). | Baseline (day 0) | ||
| Primary | Visual analog scale for pain. | Surgery is on day 0. | Day 2 | |
| Secondary | Visual analog scale for pain. | Day 0 | ||
| Secondary | Visual analog scale for pain. | Day 31 | ||
| Secondary | Operative time | From time of first incision to moment when sterile fields are removed. | Day 0 | |
| Secondary | 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. |
Day 0: post-op. | |
| Secondary | 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. |
Day 2 | |
| Secondary | 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. |
Day 31 | |
| Secondary | 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. |
Day 0: post-op. | |
| Secondary | 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. |
Day 2 | |
| Secondary | 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. |
Day 31 | |
| Secondary | 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. |
Day 0 | |
| Secondary | For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth). | Day 0 | ||
| Secondary | For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth). | Day 2 | ||
| Secondary | For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth). | Day 31 | ||
| Secondary | The consumption of analgesics | Day 0 | ||
| Secondary | The consumption of analgesics | Day 2 | ||
| Secondary | The consumption of analgesics | Day 31 | ||
| Secondary | The General Oral Health Assessment Index questionnaire | Day 0 | ||
| Secondary | The General Oral Health Assessment Index questionnaire | Day 31 |