Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG
Condition: Gingival Recession, Generalized
MeSH terms: Gingival Recession
Study type: Interventional

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.
    

Intervention name(s): de-epithelized (DE) SCTG
Intervention type(s): Procedure
Intervention description(s): subepithelial connective tissue grafts
Other intervention name(s): double blade scalpel (DBS) SCTG
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Split mouth
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: connective tissue; randomized controlled trial; gingival recession; patient outcome assessment