An interventional study of de-epithelized (DE) SCTG in Gingival Recession, Generalized, sponsored by University of Sao Paulo. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-18.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
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:
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 21 is below the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Clinical periodontal parameters
Procedure: de-epithelized (DE) SCTG
Laser Doppler Flowmetry evaluation
Procedure: de-epithelized (DE) SCTG
Pain and discomfort/ Esthetics
Procedure: de-epithelized (DE) SCTG
subepithelial connective tissue grafts
Also known as: double blade scalpel (DBS) SCTG
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
Time frame: 6 months
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
Time frame: 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;
Time frame: 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;
Time frame: 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;
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
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).
Time frame: 14 days
No study locations are listed for this record.
Plan to share: No
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University of Sao Paulo