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

Gingival Recession Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269748
• Other study ID #: 2566P
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: October 17, 2014
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: University of Padova, School of Dental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• 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

Drug:
• Analgesic Therapy
Ibuprofen 600 mg TID

Locations

Country	Name	City	State
Italy	University of Padova	Padova	PD

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova, School of Dental Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days after intervention	No
Secondary	Clinical measurements GH	Gingival recession height (GH)	12 months follow-up	No
Secondary	Clinical measurements PD	Probing depth (PD)	12 months follow-up	No
Secondary	Clinical measurements CAL	clinical attachment level (CAL)	12 months follow-up	No
Secondary	Clinical measurements KTH	height of keratinized tissue (KTH)	12 months follow-up	No