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

NCT ID: NCT04093674

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2019-02-01

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.

Conditions

Gingival Recession, Generalized

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Clinical evaluation

Clinical periodontal parameters

Group Type: EXPERIMENTAL

de-epithelized (DE) SCTG

Intervention Type: PROCEDURE

subepithelial connective tissue grafts

Laser Doppler Flowmetry

Laser Doppler Flowmetry evaluation

Group Type: EXPERIMENTAL

de-epithelized (DE) SCTG

Intervention Type: PROCEDURE

subepithelial connective tissue grafts

Patient centered outcomes

Pain and discomfort/ Esthetics

Group Type: EXPERIMENTAL

de-epithelized (DE) SCTG

Intervention Type: PROCEDURE

subepithelial connective tissue grafts

Interventions

de-epithelized (DE) SCTG

subepithelial connective tissue grafts

Intervention Type: PROCEDURE

Other Intervention Names

double blade scalpel (DBS) SCTG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mariana Ragghianti Zangrando

Assistent Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana S Ragghianti Zangrando, Professor

Role: PRINCIPAL_INVESTIGATOR

Bauru School of Dentistry-University of Sao Paulo

References

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.

Reference Type: BACKGROUND

PMID: 24640997 (View on PubMed)

Other Identifiers

SCTG21

Identifier Type: -

Identifier Source: org_study_id