Morbidity and Coverage Outcome With Connective Tissue Graft Used With Coronally Advanced Flap and Tunneling Technique
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of this randomized-controlled clinical trial is to compare the patient morbidity and
      root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with
      a coronally advanced flap (CAF) and tunnel technique (TT).

      The primary objective of the study is to demonstrate the superiority in terms of the
      post-operative course and pain of the CAF+SeCTG when compared to the TT.
    

Detailed description: 
      The aim of this randomized-controlled clinical trial is to compare the patient morbidity and
      root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with
      a coronally advanced flap (CAF) and tunnel technique (TT).

      The study will be designed as a single-centre, randomized, clinical trial on the treatment of
      single gingival recessions. The study assessed two different treatment modalities: the tunnel
      technique with subepithelial connective tissue graft (TT), compared to the coronally advanced
      flap with subepithelial connective tissue graft (CAF+SeCTG) in terms of clinical outcomes,
      and post operative morbidity.

      50 patients with one gingival recession each will be treated. Evaluation of patient morbidity
      will be performed 3 days and 1 week after the surgery. Clinical outcomes will be evaluated 12
      months post operatively. Clinical outcomes included percentage of root coverage (RC) and
      complete root coverage (CRC) will be recorded. Patient morbidity will be evaluated with
      questionnaires.

      Clinical measurements (1 week before surgery and at the 12 months follow-up)

        -  Gingival recession height (GH)

        -  Probing depth (PD)

        -  Clinical attachment level (CAL)

        -  Height of keratinized tissue (KTH)

      Patient morbidity

        -  Quantity of analgesics taken during the first week post-surgery.

        -  Patients' post operative discomfort, bleeding, stress and inability to chew was
           evaluated with a questionnaire given to patients 3 days following surgery.

      Kolmogorov-Smirnov test will be used to analyze distribution of continuous variables.
      Continuous variables are expressed as means ± standard deviation (SD) and compared at
      baseline by the U Mann-Whitney test. This test will be also used to compare mean changes post
      vs. baseline measurements. The Wilcoxon test will be used to compare post vs. baseline
      measurements. Spearman correlation will be used to evaluate associations.

      Level of significance was set at 0.05. The SPSS v. 20 software (SPSS Inc., Chicago, IL, USA)
      will be used for all analyses.
    

Intervention name(s): Tunnel technique with subepithelial connective tissue; Coronally advanced flap; Analgesic Therapy
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): After harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site.; After harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally; Ibuprofen 600 mg TID
Other intervention name(s): root coverage procedure with tunnel technique; Coronally advanced flap with sub epithelial connective tissue graft
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment