Morbidity and Coverage Outcome With Connective Tissue Graft Used With Coronally Advanced Flap and Tunneling Technique
NCT ID: NCT02269748
Last Updated: 2014-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2012-04-30
2014-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Root coverage with Tunnel (TT)
The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface
Tunnel technique with subepithelial connective tissue
After harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site.
Analgesic Therapy
Ibuprofen 600 mg TID
Coronally advanced flap (CAF+SeCTG)
The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface
Coronally advanced flap
After harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally
Analgesic Therapy
Ibuprofen 600 mg TID
Interventions
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Tunnel technique with subepithelial connective tissue
After harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site.
Coronally advanced flap
After harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally
Analgesic Therapy
Ibuprofen 600 mg TID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Molar teeth will also be excluded.
18 Years
45 Years
ALL
Yes
Sponsors
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University of Padova, School of Dental Medicine
OTHER
Responsible Party
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Luca Gobbato
Clinical Faculty Department of Periodontology
Locations
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University of Padova
Padua, PD, Italy
Countries
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Other Identifiers
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2566P
Identifier Type: -
Identifier Source: org_study_id
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