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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04093674
Enrollment
21
Registered
2019-09-18
Start date
2015-02-01
Completion date
2019-02-01
Last updated
2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession, Generalized

Keywords

connective tissue, randomized controlled trial, gingival recession, patient outcome assessment

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.

Interventions

PROCEDUREde-epithelized (DE) SCTG

subepithelial connective tissue grafts

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Split mouth

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of root coverage based on Recession depth at baseline and after 6 months6 monthsDistance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth

Secondary

MeasureTime frameDescription
Variation on: Recession width (RW) comparing baseline measurements to 6 months.6 monthsRecession width (RW) - Distance im milimeters between interproximal gingival margins of GR with periodontal probe positioned at CEJ
Variation on: Probing depth (PD) comparing baseline measurements to 6 months.6 monthsDistance 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 monthsDistance in millimeters from the CEJ to the bottom of the gingival sulcus;
Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.6 monthsDistance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
Pain and discomfort- Patient centered outcomes7 daysPain and discomfort assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (extreme pain) and 10 (no pain)
Esthetics-Patient centered outcomes6 monthsEsthetics assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)
Esthetics-Periodontist evaluation6 monthsEsthetics 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 monthsDetermined 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).

Other

MeasureTime frameDescription
Laser doppler flowmetry14 daysThe 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026