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

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT04093674
Collaborator
(none)
21
Enrollment
3
Arms
48
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: de-epithelized (DE) SCTG
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Split mouthSplit mouth
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clinical evaluation

Clinical periodontal parameters

Procedure: de-epithelized (DE) SCTG
subepithelial connective tissue grafts
Other Names:
  • double blade scalpel (DBS) SCTG

    		•
    Experimental: Laser Doppler Flowmetry

    Laser Doppler Flowmetry evaluation

    Procedure: de-epithelized (DE) SCTG
    subepithelial connective tissue grafts
    Other Names:
  • double blade scalpel (DBS) SCTG

    		•
    Experimental: Patient centered outcomes

    Pain and discomfort/ Esthetics

    Procedure: de-epithelized (DE) SCTG
    subepithelial connective tissue grafts
    Other Names:
  • double blade scalpel (DBS) SCTG

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Secondary Outcome Measures

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

    1. Laser doppler flowmetry [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    • Principal Investigator: Mariana S Ragghianti Zangrando, Professor, Bauru School of Dentistry-University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mariana Ragghianti Zangrando, Assistent Professor, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT04093674
    Other Study ID Numbers:
    • SCTG21
    First Posted:
    Sep 18, 2019
    Last Update Posted:
    Sep 18, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mariana Ragghianti Zangrando, Assistent Professor, University of Sao Paulo
    connective tissue
    randomized controlled trial
    gingival recession
    patient outcome assessment
    Additional relevant MeSH terms:
    Gingival Recession

    Study Results

    No Results Posted as of Sep 18, 2019