Clinical trial NCT02269748: Morbidity and Coverage Outcome With Connective Tissue Graft Used With Coronally Advanced Flap and Tunneling Technique
Official title: Patient Morbidity and Root Coverage Outcome After Subepithelial Connective Tissue Graft Used in Combination With Coronally Advanced Flap and Tunneling Technique: a Comparative Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: University of Padova, School of Dental Medicine
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Single Miller's Class I or Class II recession defects 2 to 4 mm range of recession height will be included presence of identifiable cemento enamel junction (CEJ) presence of a root abrasion, but with an identifiable CEJ, will be accepted; periodontally and systemically healthy no contraindications for periodontal surgery no taking medications known to interfere with periodontal tissue health or healing no periodontal surgery on the involved sites.

Exclusion Criteria:

Subjects smoking more than 10 cigarettes a day will be excluded. Recession defects associated with caries or restoration as well as teeth with evidence of a pulpal pathology will not be included.

Molar teeth will also be excluded.

Primary outcomes:
measure: Patient morbidity
timeFrame: 3 days after intervention
Secondary outcomes:
measure: Clinical measurements GH
timeFrame: 12 months follow-up
measure: Clinical measurements PD
timeFrame: 12 months follow-up
measure: Clinical measurements CAL
timeFrame: 12 months follow-up
measure: Clinical measurements KTH
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
state: PD
Study officials:
References: