Morbidity and Coverage Outcome With Connective Tissue Graft Used With Coronally Advanced Flap and Tunneling Technique

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Tunnel technique with subepithelial connective tissue; Procedure: Coronally advanced flap; Drug: Analgesic Therapy

• Registration Number: NCT02269748
• Lead Sponsor: University of Padova, School of Dental Medicine

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-10
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-17
• Last Update Submitted: 2014-10-17
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Root coverage with Tunnel (TT)	Analgesic Therapy	The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface
Coronally advanced flap (CAF+SeCTG)	Analgesic Therapy	The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface
Root coverage with Tunnel (TT)	Tunnel technique with subepithelial connective tissue	The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface
Coronally advanced flap (CAF+SeCTG)	Coronally advanced flap	The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface

Primary Outcome Measures

Name	Time	Method
Patient morbidity	3 days after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Clinical measurements GH	12 months follow-up	Gingival recession height (GH)
Clinical measurements KTH	12 months follow-up	height of keratinized tissue (KTH)
Clinical measurements PD	12 months follow-up	Probing depth (PD)
Clinical measurements CAL	12 months follow-up	clinical attachment level (CAL)

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, PD, Italy