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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tunnel technique with subepithelial connective tissue
Coronally advanced flap
Analgesic Therapy
Sponsored by
University of Padova, School of Dental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Root coverage with Tunnel (TT)

Coronally advanced flap (CAF+SeCTG)

Arm Description

The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface

The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical measurements GH
Gingival recession height (GH)
Clinical measurements PD
Probing depth (PD)
Clinical measurements CAL
clinical attachment level (CAL)
Clinical measurements KTH
height of keratinized tissue (KTH)

Full Information

First Posted
October 15, 2014
Last Updated
October 17, 2014
Sponsor
University of Padova, School of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02269748
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova, School of Dental Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Root coverage with Tunnel (TT)
Arm Type
Experimental
Arm Description
The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface
Arm Title
Coronally advanced flap (CAF+SeCTG)
Arm Type
Active Comparator
Arm Description
The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface
Intervention Type
Procedure
Intervention Name(s)
Tunnel technique with subepithelial connective tissue
Other Intervention Name(s)
root coverage procedure with tunnel technique
Intervention Description
After harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site.
Intervention Type
Procedure
Intervention Name(s)
Coronally advanced flap
Other Intervention Name(s)
Coronally advanced flap with sub epithelial connective tissue graft
Intervention Description
After harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally
Intervention Type
Drug
Intervention Name(s)
Analgesic Therapy
Intervention Description
Ibuprofen 600 mg TID
Primary Outcome Measure Information:
Title
Patient morbidity
Description
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.
Time Frame
3 days after intervention
Secondary Outcome Measure Information:
Title
Clinical measurements GH
Description
Gingival recession height (GH)
Time Frame
12 months follow-up
Title
Clinical measurements PD
Description
Probing depth (PD)
Time Frame
12 months follow-up
Title
Clinical measurements CAL
Description
clinical attachment level (CAL)
Time Frame
12 months follow-up
Title
Clinical measurements KTH
Description
height of keratinized tissue (KTH)
Time Frame
12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Padova
City
Padova
State/Province
PD
ZIP/Postal Code
35122
Country
Italy

12. IPD Sharing Statement

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

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