Clinical trial NCT04093674: Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession, Generalized
Keywords: connective tissue
randomized controlled trial
gingival recession
patient outcome assessment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Split mouth
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of root coverage based on Recession depth at baseline and after 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Variation on: Recession width (RW) comparing baseline measurements to 6 months.
timeFrame: 6 months
measure: Variation on: Probing depth (PD) comparing baseline measurements to 6 months.
timeFrame: 6 months
measure: Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.
timeFrame: 6 months
measure: Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.
timeFrame: 6 months
measure: Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.
timeFrame: 6 months
measure: Pain and discomfort- Patient centered outcomes
timeFrame: 7 days
measure: Esthetics-Patient centered outcomes
timeFrame: 6 months
measure: Esthetics-Periodontist evaluation
timeFrame: 6 months
Other outcomes:
measure: Laser doppler flowmetry
timeFrame: 14 days
Locations:
Study officials:
affiliation: Bauru School of Dentistry-University of Sao Paulo
name: Mariana S Ragghianti Zangrando, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.