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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02269748
Other study ID # 2566P
Secondary ID
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


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
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