Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG

Study Overview
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Brief Summary
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This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral RT 1 multiple gingival recessions after 6 months postoperatively. 21 patients with 84 sites were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelized (DE) SCTG. Periodontal clinical parameters and aesthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and aesthetics were assessed with Visual Analogue Scale (VAS) after 7 days and 6 months, respectively. Gingival blood flows were analyzed by Laser Doppler flowmetry (FLD) at baseline and 2, 7 and 14 days postoperatively.

Detailed Description
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Clinical parameters and patient-centered outcomes Periodontal clinical examination was performed by a blind and calibrated examiner (intra-class correlation coefficient = 0.72) using a North Carolina periodontal probe (PCPUNC-Hu-Friedy®). Periodontal parameters were evaluated at baseline and after 6 months postoperatively and included: Recession depth (RD) - Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth; Recession width (RW) - Distance between interproximal gingival margins of GR with periodontal probe positioned at CEJ; Probing depth (PD) - Distance in millimeters from the gingival margin to the bottom of the gingival sulcus; Clinical attachment level (CAL) - Distance in millimeters from the CEJ to the bottom of the gingival sulcus; Keratinized tissue width (KTW) - Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth; Keratinized tissue thickness (KTT): determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper. The index proposed by Zucchelli & DeSanctis (2000) was used to calculate percentage of root coverage (%RC), as follows: RRC=(100.(RD baseline-RD 6 months))/(RD baseline) Patient centered outcomes and professional assessment were evaluated with visual analog scales (VAS). VAS was administered verbally to the patients to assess aesthetics and postoperative pain/discomfort. Patients were asked to make a mark in a scale between 0 (not satisfied or extreme pain) and 10 (very satisfied or no pain). Pain and discomfort were recorded after 7 days and patient´s aesthetic evaluation after 6 months. An experienced periodontist (intra-class correlation coefficient = 0.95) evaluated aesthetic outcome after 6 months. The Laser Doppler flowmetry (LDF) technique (VMS-LDF2 DUAL CHANNEL- Laser Doppler Blood Flow and Temperature Monitor (Moor instruments- process number-FAPESP 2012/13331-2) was used to evaluate blood flow on the recipient sites. LDF is equipped with a laser diode that emits in the infrared spectrum range (Maximum power - 2.5mW, wavelenghts 785nm±10nm). Measurements with LDF were performed with two probes for 1 minute and 30 seconds. These measurements were recorded three times for each site with intervals of one minute.

Official Title
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Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Double Blade Scalpel (DBS) and De-epithelized (DE) SCTG Associated With Coronally Advanced Flap (CAF): a Split-mouth Randomized Clinical Trial

Conditions
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Gingival Recession, Generalized

Intervention / Treatment
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* Procedure: de-epithelized (DE) SCTG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systemically healthy patients between 18 and 70 years clinical diagnosis of bilateral multiple gingival recessions, recession type (RT) 1 (Cairo et al. 2011) with at least one gingival recession ≥ 2 mm on each side, including canines and premolars. Exclusion Criteria: abnormal teeth position smokers, pregnant or nursing women parafunctional habits plaque and bleeding indexes (Ainamo & Bay, 1975) above 20% previous periodontal surgeries on selected sites.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Sequential Assignment
Interventional Model Description: Split mouth
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical evaluation<br>Clinical periodontal parameters | Procedure: de-epithelized (DE) SCTG<br>* subepithelial connective tissue grafts<br>* Other names: double blade scalpel (DBS) SCTG;|
| Experimental: Laser Doppler Flowmetry<br>Laser Doppler Flowmetry evaluation | Procedure: de-epithelized (DE) SCTG<br>* subepithelial connective tissue grafts<br>* Other names: double blade scalpel (DBS) SCTG;|
| Experimental: Patient centered outcomes<br>Pain and discomfort/ Esthetics | Procedure: de-epithelized (DE) SCTG<br>* subepithelial connective tissue grafts<br>* Other names: double blade scalpel (DBS) SCTG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of root coverage based on Recession depth at baseline and after 6 months | Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation on: Recession width (RW) comparing baseline measurements to 6 months. | Recession width (RW) - Distance im milimeters between interproximal gingival margins of GR with periodontal probe positioned at CEJ | 6 months | 
| Variation on: Probing depth (PD) comparing baseline measurements to 6 months. | Distance in millimeters from the gingival margin to the bottom of the gingival sulcus; | 6 months | 
| Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months. | Distance in millimeters from the CEJ to the bottom of the gingival sulcus; | 6 months | 
| Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months. | Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth; | 6 months | 
| Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months. | Determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper (determined in mm). | 6 months | 
| Pain and discomfort- Patient centered outcomes | Pain and discomfort assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (extreme pain) and 10 (no pain) | 7 days | 
| Esthetics-Patient centered outcomes | Esthetics assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (not satisfied) and 10 (very satisfied) | 6 months | 
| Esthetics-Periodontist evaluation | Esthetics assessed using Visual Analog Scale: an experienced periodontist make a mark in a scale between 0 (not satisfied) and 10 (very satisfied) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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connective tissue, randomized controlled trial, gingival recession, patient outcome assessment