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OpenTrials
Completed

NCT Number: NCT04093674

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • Recession depth (RD) - Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth;
  • Recession width (RW) - Distance between interproximal gingival margins of GR with periodontal probe positioned at CEJ;
  • Probing depth (PD) - Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
  • Clinical attachment level (CAL) - Distance in millimeters from the CEJ to the bottom of the gingival sulcus;
  • Keratinized tissue width (KTW) - Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

de-epithelized (DE) SCTG

Procedure

subepithelial connective tissue grafts

Other names: double blade scalpel (DBS) SCTG

Primary outcomes

  1. Percentage of root coverage based on Recession depth at baseline and after 6 months

    Time frame: 6 months

    Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth

Secondary outcomes

  1. Variation on: Recession width (RW) comparing baseline measurements to 6 months.

    Time frame: 6 months

    Recession width (RW) - Distance im milimeters between interproximal gingival margins of GR with periodontal probe positioned at CEJ

  2. Variation on: Probing depth (PD) comparing baseline measurements to 6 months.

    Time frame: 6 months

    Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;

  3. Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.

    Time frame: 6 months

    Distance in millimeters from the CEJ to the bottom of the gingival sulcus;

  4. Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.

    Time frame: 6 months

    Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;

  5. Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.

    Time frame: 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. Pain and discomfort- Patient centered outcomes

    Time frame: 7 days

    Pain and discomfort assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (extreme pain) and 10 (no pain)

  7. Esthetics-Patient centered outcomes

    Time frame: 6 months

    Esthetics assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)

  8. Esthetics-Periodontist evaluation

    Time frame: 6 months

    Esthetics assessed using Visual Analog Scale: an experienced periodontist make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)

Other outcomes

  1. Laser doppler flowmetry

    Time frame: 14 days

    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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Sep 18, 2019
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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