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

Gingival Recession, Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093674
• Other study ID #: SCTG21
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: February 1, 2019

Study information

• Verified date: September 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Generalized

Intervention

Procedure:
• de-epithelized (DE) SCTG
subepithelial connective tissue grafts

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

References & Publications (1)

Zuhr O, Bäumer D, Hürzeler 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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