Gum Recession
Conditions
Keywords
Gum recession, Recession treatment, Tunnel technique, Connective tissue graft, Gingival recession
Brief summary
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.
Interventions
PROCEDURESelective/Segmented graft
In this group a segmented CTG will be used
PROCEDUREContinuous graft
In this group a continuous CTG will be used
Sponsors
Centre Hospitalier Universitaire de Liege
26K Center for Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ASA I or ASA II * Good periodontal health * Able to undergo oral surgery * Must be 18 years old and older * No smoking * At least two teeth in the same sector in the maxilla and the right and left mandible (except in the mandibular incisive sector), of which at least 2 are contiguous, with vestibular gingival recessions of type RT 1 of 1-5mm (Cairo et al. 2011) * An identifiable or restorable cemento-enamel junction (CEJ), with or without the presence of a non-carious cervical lesion (Pini-Prato et al. 2010) * Plaque index (O'Leary 1972) and bleeding index (Ainamo et al. 1975) scores of less than 20% * Able to give informed consent and have signed the consent forms
Exclusion criteria
* Teeth showing recession associated with a carious lesion, restoration or cervical prosthesis involving CEJ * Teeth with recession depth \>5mm * Molars with recessions will be treated but will not be taken into account for the measurements * Teeth with recession that have already undergone periodontal surgery * Presence of severe tooth malposition, rotation or significant version of the tooth * Smoker and ex-smoker * Patient suffering from a disease affecting the periodontium * Patient with clinical signs of active periodontitis * Known pregnancy in progress or breastfeeding * Contraindication to surgery * Conditions or circumstances which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability * Patients deprived of their liberty or under legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digital complete root coverage | 3, 6 and 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Root Coverage | 3, 6 and 12 months | 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 (%). |
| Keratinized Tissue Height | 3, 6 and 12 months | 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. |
| Recession reduction | 3, 6 and 12 months | 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. |
| Dental hypersensitivity | 3, 6 and 12 months | Assessed by 10 s air spray applied to the buccal cervical area (yes/no). |
| Root-coverage Esthetic Score | 3, 6 and 12 months | Evaluated at the different timepoints according to Cairo et al. (2009). |
| Digital mean root coverage | 3, 6 and 12 months | 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%. |
| Digital recession reduction | 3, 6 and 12 months | 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. |
| Digital Gingival soft tissues profile | 3, 6 and 12 months | 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. |
| Volumetric Changes | 3, 6 and 12 months | evaluated as 3D changes in the volume of gingival tissue between different timepoints, measured using the digital impression. |
| Complete Root Coverage | 3, 6 and 12 months | 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. |
| Patient Reported Outcome Measures | 1, 2, 3, 4, 5, 6, 7, 14 days and 3, 6, 12 months | 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 |
Countries
Belgium, France
Outcome results
None listed