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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession, Generalized
• Intervention / Treatment: Procedure: de-epithelized (DE) SCTG

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser doppler flowmetry	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).	14 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Mariana S Ragghianti Zangrando, Professor, Bauru School of Dentistry-University of Sao Paulo

Publications and helpful links

General Publications

• Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2015
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (ACTUAL): September 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: randomized controlled trial; gingival recession; connective tissue; patient outcome assessment
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: SCTG21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No