Root Coverage Comparing Suturing Techniques

NCT ID: NCT01901822

Last Updated: 2016-12-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-07-31

Brief Summary

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The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix using a continuous sling suture to secure both the graft and the flap will result in better percent root coverage compared to the continuous sling suturing technique to secure the graft and the flap separately.

Detailed Description

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Thirty patients will be selected by meeting the following criteria:

Inclusion Criteria:

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be between ≥ 18 years of age.

Exclusion Criteria:

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis. D. Root surface restorations at the site of recession. E. No detectable cemento-enamel junction. F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.

G. Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or guided tissue regeneration, on the test teeth.

L. Patients who fail to complete the informed consent form.

Conditions

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Root Coverage

Keywords

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acellular dermal matrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sutured separately

The soft tissue and the allograft will each be sutured separately using a continuous sling suture.

Group Type ACTIVE_COMPARATOR

Sutured separately

Intervention Type PROCEDURE

The soft tissue and the allograft will be sutured separately using a continuous sling suture.

Sutured together

The soft tissue and the allograft will be sutured together using a continuous sling suture.

Group Type EXPERIMENTAL

Sutured together

Intervention Type PROCEDURE

The soft tissue and the allograft will be sutured together using a continuous sling suture.

Interventions

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Sutured together

The soft tissue and the allograft will be sutured together using a continuous sling suture.

Intervention Type PROCEDURE

Sutured separately

The soft tissue and the allograft will be sutured separately using a continuous sling suture.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
* The mucogingival defect must be on a non-molar tooth.
* Patients must be between ≥ 18 years of age.

Exclusion Criteria

* Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
* Patients requiring antibiotic prophylaxis.
* Root surface restorations at the site of recession.
* No detectable cemento-enamel junction.
* Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
* Patients who are pregnant or lactating.
* Patients who use tobacco products (smoking or smokeless tobacco).
* Patients with alcohol abuse problems.
* Patients undergoing long-term steroid therapy.
* History of previous root coverage procedures, graft or guided tissue regeneration, on the test teeth.
* Patients who fail to complete the informed consent form.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Henry Greenwell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry Greenwell, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Graduate Periodontics Clinic University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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13.0332

Identifier Type: -

Identifier Source: org_study_id