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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
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
University of Padova
Padova, PD, Italy
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.
Time frame: 3 days after intervention
Clinical measurements GH
Gingival recession height (GH)
Time frame: 12 months follow-up
Clinical measurements PD
Probing depth (PD)
Time frame: 12 months follow-up
Clinical measurements CAL
clinical attachment level (CAL)
Time frame: 12 months follow-up
Clinical measurements KTH
height of keratinized tissue (KTH)
Time frame: 12 months follow-up
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