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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00512-45 | Other Identifier | ANSM |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suturing of lower alveoli | Procedure | After extraction of wisdom teeth, the lower alveoli are sutured closed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale for pain. | Surgery is on day 0. | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale for pain. | Day 0 | |
| Visual analog scale for pain. | Day 31 | |
| Operative time |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Baseline (day 0) | |
| Gender | Baseline (day 0) | |
| Body mass index |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Lapeyrie, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier - Hôpital Gui de Chauliac | Montpellier | 34295 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35754043 | Result | 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. |
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| Non suturing of lower alveoli | Procedure | After extraction of wisdom teeth, no alveoli are sutured closed. |
|
From time of first incision to moment when sterile fields are removed.
| Day 0 |
| 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. |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| The occurrence of complications | The occurrence of at least one complication among the following with at least one of the 4 teeth:
| Day 0 |
| For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth). | Day 0 |
| For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth). | Day 2 |
| For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth). | Day 31 |
| The consumption of analgesics | Day 0 |
| The consumption of analgesics | Day 2 |
| The consumption of analgesics | Day 31 |
| The General Oral Health Assessment Index questionnaire | Day 0 |
| The General Oral Health Assessment Index questionnaire | Day 31 |
| Baseline (day 0) |
| Number of cigarettes smoked per day | Day 0 |
| Number of cigarettes smoked per day | Day 2 |
| Number of cigarettes smoked per day | Day 31 |
| Proximity of the M3 nerve for each tooth | Baseline (day 0) |
| Winter classification for each tooth | Baseline (day 0) |
| Delay between surgery and the first post-operative measure (e.g. for edema or trismus) | Day 0 |
| Surgical indication (i.e. why the avulsion is being performed). | Baseline (day 0) |
| Nîmes |
| 30029 |
| France |
| CH de Perpignan - Hôpital Saint Jean | Perpignan | 66046 | France |