NCT04093674

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

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: 1. Recession depth (RD) - Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth; 2. Recession width (RW) - Distance between interproximal gingival margins of GR with periodontal probe positioned at CEJ; 3. Probing depth (PD) - Distance in millimeters from the gingival margin to the bottom of the gingival sulcus; 4. Clinical attachment level (CAL) - Distance in millimeters from the CEJ to the bottom of the gingival sulcus; 5. Keratinized tissue width (KTW) - Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth; 6. 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.

Conditions

• Gingival Recession, Generalized

Interventions

Type	Name	Description
PROCEDURE	de-epithelized (DE) SCTG	subepithelial connective tissue grafts

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2019-02-01
• First posted: 2019-09-18
• Last updated: 2019-09-18