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| Name | Class |
|---|---|
| 26K Center for Clinical Research | UNKNOWN |
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The goal of this study is to evaluate how effective a gum grafting procedure is in treating gum recession that affects several teeth. Gum recession happens when the gum tissue pulls away from the tooth, exposing the roots. The study will look at how the treatment improves gum health, appearance, and function.
A total of 32 patients will take part in the study. All patients will be treated with a modified coronally advanced tunnel. For half of them of contiguous graft will be used, for the other half a segmented graft.
Data collected will include medical history, dental and aesthetic information, clinical measurements, and a digital scan of the mouth.
The study will include the following steps:
Before the procedure: You will have a clinical and X-ray examination to determine how much your gums have receded. A digital impression of your teeth will also be taken.
Surgical procedure: You will receive a gum graft to cover the exposed roots. This involves moving gum tissue, often taken from the roof of your mouth, to the affected areas.
After the procedure: You will have several follow-up visits over a few months to check your healing and the results of the treatment.
Study timeline:
The surgery will be done once. Follow-up visits will take place 1, 3, 6, and 12 months after the surgery. The total duration of the study is about 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective/Segmented graft | Experimental | In this group a segmented CTG will be used |
|
| Continuous graft | Active Comparator | In this group a continuous CTG will be used |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective/Segmented graft | Procedure | In this group a segmented CTG will be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| Digital complete root coverage | defined as the presence/absence of complete coverage of the recession at the mid-buccal aspect. It will be evaluated by taking the CEJ as a reference line, at the different timepoints, analysed digitally using the digital impression | 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Root Coverage | defined as the presence/absence of complete coverage of the recession at the mid-buccal aspect. It will be evaluated by taking the CEJ as a reference line, at the different timepoints. | 3, 6 and 12 months |
| Mean Root Coverage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Liège | Recruiting | Liège | Liège | 4000 | Belgium |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Continuous graft | Procedure | In this group a continuous CTG will be used |
|
defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a refer-ence. It equals to difference of the linear distance (in mm, using probe) between the mid-buccal point of the CEJ and the mid-buccal margin at baseline and different timepoints, divided by the distance between the mid buccal point of the CEJ and the mid buccal margin at baseline. The MRC will be measured as percentage (%).
| 3, 6 and 12 months |
| Keratinized Tissue Height | Defined as the linear height of keratinized tissue, measured between the mid-buccal gingival mar-gin of the treated tooth and the muco-gingival junction (in mm using a probe). It will be measured at baseline and at the different timepoints. | 3, 6 and 12 months |
| Recession reduction | defined as the linear reduction in recession (in mm using a probe), at the mid buccal aspect, be-tween baseline and the different timepoints. It will be measured at the different timepoints. | 3, 6 and 12 months |
| Dental hypersensitivity | Assessed by 10 s air spray applied to the buccal cervical area (yes/no). | 3, 6 and 12 months |
| Root-coverage Esthetic Score | Evaluated at the different timepoints according to Cairo et al. (2009). | 3, 6 and 12 months |
| Digital mean root coverage | Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a refer-ence. Measured by dividing the mean surface (in mm²) of the root covered by the procedure by the mean surface (in mm²) of root exposed at baseline. Measured digitally at 3-6 months and 1 year after surgery. [(Initial Exposed Root Surface(mm2) - Post-operative exposed root surface(mm2)) / Initial Exposed Root Surface(mm2)] x 100%. | 3, 6 and 12 months |
| Digital recession reduction | defined as the reduction in recession (in mm², measured digitally), at the mid-buccal aspect, be-tween baseline and the different timepoints. It will be measured at the different timepoints. | 3, 6 and 12 months |
| Digital Gingival soft tissues profile | Defined as the change in gingival soft tissue thickness between baseline and the different timepoints, measured at the mid buccal aspect, between baseline and the different timepoints tak-ing CEJ as reference. | 3, 6 and 12 months |
| Volumetric Changes | evaluated as 3D changes in the volume of gingival tissue between different timepoints, measured using the digital impression. | 3, 6 and 12 months |
| Patient Reported Outcome Measures | Self-perceived pain: Reported on a 100mm VAS scale ranging from 0 (no pain at all) to 100 (worst pain possible). Number, nature and frequency of medication: Patients will be asked to report every take of medica-tion (substance, posology, and time of the day). Swelling: Reported on a 100 mm VAS scale ranging from 0 (no swelling at all) to 100 (worst swelling possible). T Bleeding: Reported on a 100 mm VAS scale ranging from 0 (no bleeding at all) to 100 (worst bleed-ing possible). Discomfort during surgery: Reported on a 100 mm VAS scale ranging from 0 (no discomfort at all) to 100 (a lot of discomfort). Self-perceived hypersensitivity Aesthetic outcome (self-evaluation): Reported on a 100 mm VAS scale ranging from 0 (no not satis-fied at all) to 100 (best outcome they could imagine). Report other adverse effects/ complications | 1, 2, 3, 4, 5, 6, 7, 14 days and 3, 6, 12 months |
| 26K Center for clinical research | Not yet recruiting | Paris | 75116 | France |
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| D055093 |
| Periodontal Atrophy |