Gingival Recession, Gingival Recession, Localized
Conditions
Keywords
Gingival recession, Free gingival graft, Connective tissue graft
Brief summary
This study wil compare FGG and CTG for recession coverage in the anterior mandibula.
Interventions
PROCEDUREFree gingival graft
A free gingival graft will be carried out for recession treatment.
PROCEDUREConnective tissue graft
The pouch technique with a connective tissue graft will be carried out for recession treatment.
Sponsors
Centre Hospitalier Universitaire de Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA type I and II subjects * Localized Gingival Recessions * Recessions Cairo RT I-II-III * FMPS \< 10% * FMBS\< 10% * \<10 cigs/ day * No contra-indication against oral surgical interventions * Patient is able to give inform consent
Exclusion criteria
* Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests. * ASA type \> II * Current pregnancy or breastfeeding women * Alcoholism or chronically drug abuse * Smokers, ≳ 10 cigarettes per day * Immunocompromised patients * Uncontrolled diabetes * Untreated periodontitis * History of previous periodontal surgery (mucogingival or other) on the teeth to be included * Presence of severe tooth malposition, rotation or significant version of the tooth to be treated * Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digital mean root coverage | Baseline, 3 months, 6 months and up to 10 years after surgery | Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean root coverage | Baseline, 3 months, 6 months and up to 10 years after surgery | defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. The MRC equals to the linear distance (in mm, using a probe) between the mid buccal point of the CEJ and the mid-buccal sulcus at baseline, divided by the distance between the mid buccal point of the CEJ and the mid buccal sulcus. The MRC will be measured as percentage (%) |
| Keratinized tissue height | Baseline, 3 months, 6 months and up to 10 years after surgery | Defined as the linear height of keratinized tissue, measured between the mid-buccal sulcus 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 | Baseline, 3 months, 6 months and up to 10 years after surgery | defined as the linear reduction in recession (in mm using a probe), at the mid buccal aspect, between baseline and the different timepoints. |
| Gingival thickness | Baseline, 3 months, 6 months and up to 10 years after surgery | evaluated at baseline using couloured paperpoints inserted into the sulcus. |
| CAL | Baseline, 3 months, 6 months and up to 10 years after surgery | defined as the change in Clinical Attachement of the gingival margin, measured linearly at the mid-buccal aspect, from the JEC to the bottom of the pocket, at the different timepoints. |
| PPD changes | Baseline, 3 months, 6 months and up to 10 years after surgery | defined as the change in depth of the pocket, measured at the mid-buccal aspect using a probe, between baseline and the different timepoints. It will be measured at the different timepoints. |
| Complete root coverage | Baseline, 3 months, 6 months and up to 10 years after surgery | 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. |
| Root coverage esthetic score | Baseline, 3 months, 6 months and up to 10 years after surgery | Evaluated at the different timepoints according to Cairo et al. (2009). |
| Biological complications reported by the investigators | Baseline, 3 months, 6 months and up to 10 years after surgery | Biological complications reported by the investigators |
| Digital complete root coverage | Baseline, 3 months, 6 months and up to 10 years after surgery | 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, analyzed digitally |
| Digital recession reduction | Baseline, 3 months, 6 months and up to 10 years after surgery | defined as the reduction in recession (in mm², measured digitally), at the mid buccal aspect, between baseline and the different timepoints. It will be measured at the different timepoints. |
| Digital Keratinized Tissue Height | Baseline, 3 months, 6 months and up to 10 years after surgery | Defined as the changes in keratinized tissue surface (surface delimited mesio-distally by the perpendicular projection of a line passing by the contact-point and apico-coronally by the muco-gingival junction and the gingival margin, at the mid-buccal aspect of the tooth. |
| Digital gingival soft tissue profile | Baseline, 3 months, 6 months and up to 10 years after surgery | 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. |
| Dental hypersensitivity | Baseline, 3 months, 6 months and up to 10 years after surgery | Assessed by 10 s air spray applied to the buccal cervical area (yes/no). |
Countries
Belgium
Contacts
Primary ContactFrance Lambert, PhD
Backup ContactIsabelle Laleman, PhD
Outcome results
None listed