CAF With or Without CTG for the Treatment of Single Maxillary Gingival Recession With NCCL

Study Overview
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Brief Summary
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This studies evaluate the efficacy of the coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of single maxillary recession associated to non carious cervical lesion (NCCL).

Official Title
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Coronally Advanced Flap (CAF) and Composite Restoration of the Enamel With or Without Connective Tissue Graft (CTG) for the Treatment of Single Maxillary Gingival Recession With Non-carious Cervical Lesion (NCCL). A Randomized Controlled Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: CAF
* Procedure: CAF + CTG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years No systemic diseases or pregnancy. Self-reported smoking ≤ 10 cigarettes/day. Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 10% (measured at four sites per tooth). Presence of single RT1 buccal gingival recessions ≥ 2 mm of depth located in the anterior area of the upper jaw (central and lateral incisors, canine, first and second pre-molars, first molar) and associated with aesthetic complains and or dental sensitivity. Presence of NCCL associated with recession No history of mucogingival or periodontal surgery at experimental sites. Exclusion Criteria: Prosthetic crown at experimental teeth. Gingival recessions presenting minimal amount (< 1mm) of apico-coronal keratinized tissue (KT) extension apical to recession area.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAF<br>After the restoration of the enamel patients were treated with a CAF | Procedure: CAF<br>* After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession<br>|
| Experimental: CAF + CTG<br>After the restoration of the enamel patients were treated with a CAF + CTG | Procedure: CAF + CTG<br>* After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised. Then a connective tissue graft was harvested from the palate and sutured over the exposed root. Finally the flap was coronally advanced and sutured to cover the recession<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession Reduction | Difference between gingival recession at 12 months and baseline, measured with a periodontal probe. | At 12 months | 
| Complete Root Coverage (CRC) | Absence or presence of gingival recession at 12 months follow-up. | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root coverage Esthetic Score (RES) | Overall esthetic score from 0 to 10 evaluated by the blinded examiner. Higher values represent a better outcome. (Pini-Prato et al. 2011) | At 12 months | 
| Gingival Thickness (GT) | Gingival thickness in mm, measured with an endodontic file and a digital caliper. | Baseline - 12 months | 
| Keratinized Tissue (KT) | Width of the keratinized gingiva measured in mm from the gingival margin to the muco-gingival-junction using a periodontal probe | Baseline - 6 and 12 months | 
| KTgain | Gain of Keratinized Tissue measured as the difference between KT at 12 months and KT baseline | At 12 months | 
| Gingival Recesión (REC) | The distance between the reconstructed cementum enamel junction and the gingival margin measured in mm with a periodontal probe | Baseline - 6 and 12 months | 
| Root sensitivity | Toot sensitivity reported by the patient present or absent | Baseline - 6 and 12 months | 
| SensVAS | Toot sensitivity reported by the patient on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome. | Baseline - 6 and 12 months | 
| SurTime | Surgical Time in minutes from the end of anesthesia to the sutures | At surgery | 
| Anti-infammTab | Number of tablets of anti-inflammatory drug taken in the first week post-operatively by the patients. | 1 week post-surgery | 
| DiscVAS | Post Operative Discomfort reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome. | 1 week post-surgery | 
| AesthVAS | Aesthetic overall satisfaction reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent better outcomes. | At 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival recession, Non-carious cervical lesion, Connective tissue graft