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

Not Applicable

Completed

• Conditions: Gingival Recession, Generalized
• Interventions: Procedure: de-epithelized (DE) SCTG

• Registration Number: NCT04093674
• Lead Sponsor: University of Sao Paulo

Brief 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.

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2017-02-01
• Study Completion: 2019-02-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-16
• Last Update Submitted: 2019-09-16
• Study First Posted: 2019-09-18
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Laser Doppler Flowmetry	de-epithelized (DE) SCTG	Laser Doppler Flowmetry evaluation
Patient centered outcomes	de-epithelized (DE) SCTG	Pain and discomfort/ Esthetics
Clinical evaluation	de-epithelized (DE) SCTG	Clinical periodontal parameters

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Variation on: Recession width (RW) comparing baseline measurements to 6 months.	6 months	Recession width (RW) - Distance im milimeters between interproximal gingival margins of GR with periodontal probe positioned at CEJ
Pain and discomfort- Patient centered outcomes	7 days	Pain and discomfort assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (extreme pain) and 10 (no pain)
Esthetics-Periodontist evaluation	6 months	Esthetics assessed using Visual Analog Scale: an experienced periodontist make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)
Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.	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).
Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.	6 months	Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
Esthetics-Patient centered outcomes	6 months	Esthetics assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)
Variation on: Probing depth (PD) comparing baseline measurements to 6 months.	6 months	Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.	6 months	Distance in millimeters from the CEJ to the bottom of the gingival sulcus;