The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes

NCT ID: NCT03539939

Last Updated: 2018-05-30

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-03

Study Completion Date

2013-01-07

Brief Summary

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Cigarette smoking is a patient-related factor that can affect healing of periodontal tissues and the success rate of root-coverage procedures. Neither the nature nor the mechanisms of action of cigarette smoking on root coverage are fully understood. Therefore, the hypothesis that cigarette smoking has negative impacts on the outcomes of root coverage after CAF surgery in systemically healthy individuals with an initial gingival thickness of at least 0.8 mm and who practice optimal oral hygiene was tested. It was also hypothesized that baseline analysis of disease-related biomarkers would shed light on the underlying mechanisms of a possible effect.

Detailed Description

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Conditions

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Gingival Recession Smoking

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Smoker Group

This group included smoker gingival recession patients.

Group Type EXPERIMENTAL

Coronally Advanced Flap

Intervention Type PROCEDURE

The coronally advanced flap (CAF) is a procedure frequently used in periodontal plastic surgery. The main objective of this surgical technique is to mobilize the gingival margin and reposition it at a level more coronal (incisal direction) than its original location. CAF is mainly used for the treatment of gingival recessions.

Non-smoker Group

This group included non-smoker gingival recession patients.

Group Type ACTIVE_COMPARATOR

Coronally Advanced Flap

Intervention Type PROCEDURE

The coronally advanced flap (CAF) is a procedure frequently used in periodontal plastic surgery. The main objective of this surgical technique is to mobilize the gingival margin and reposition it at a level more coronal (incisal direction) than its original location. CAF is mainly used for the treatment of gingival recessions.

Interventions

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Coronally Advanced Flap

The coronally advanced flap (CAF) is a procedure frequently used in periodontal plastic surgery. The main objective of this surgical technique is to mobilize the gingival margin and reposition it at a level more coronal (incisal direction) than its original location. CAF is mainly used for the treatment of gingival recessions.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Maxillary central and lateral incisors, canines, and premolars and mandibular premolars with isolated buccal recessions classified as Miller Class I or II
* Study tooth should present tooth vitality, identifiable cemento-enamel junction (CEJ) and absence of caries, restorations or extensive non-carious cervical lesion.

Exclusion Criteria

* Medical disorders such as diabetes mellitus, immunologic disorders, hepatitis
* History of previous mucogingival surgery at the gingival recession site
* Medications known to affect gingival tissues
* Antibiotic treatment in the past 6 months
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role collaborator

Ege University

OTHER

Sponsor Role lead

Responsible Party

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Nurcan Buduneli

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2010-DIS-004

Identifier Type: -

Identifier Source: org_study_id

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