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

Not Applicable

Completed

• Conditions: Gingival Recession; Smoking
• Interventions: Procedure: Coronally Advanced Flap

• Registration Number: NCT03539939
• Lead Sponsor: Ege University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-05-03
• Primary Completion: 2012-06-07
• Study Completion: 2013-01-07
• Status Verified: 2018-05
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-25
• Last Update Submitted: 2018-05-25
• Study First Posted: 2018-05-30
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoker Group	Coronally Advanced Flap	This group included smoker gingival recession patients.
Non-smoker Group	Coronally Advanced Flap	This group included non-smoker gingival recession patients.

Primary Outcome Measures

Name	Time	Method
Change in the percentage of root coverage	1-month, 3-month and 6-month after coronally advanced flap (CAF)	Root coverage were measured on digital photographs using specific software.

Secondary Outcome Measures

Name	Time	Method
Change in the percentage of complete root coverage	1-month, 3-month and 6-month after coronally advanced flap (CAF)
Change in gingival thickness	Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)	Gingival thickness was measured with an ultrasonic device that uses the pulse echo principle. Ultrasonic pulses are transmitted at intervals of 1 millisecond through the sound-permeable mucosa and reflected, in part, at the surface of the alveolar bone or tooth attributable to different acoustic impedance. When an acoustic signal is transmitted within 2 to 3 seconds, gingival thickness is digitally displayed with a sensitivity of 0.01 mm.
Changing of the gingival crevicular fluid (GCF) biomarkers	Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Changing of the salivary biomarkers	Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Change in the visual analog scale (VAS) values	1 to 7 day after coronally advanced flap (CAF)	The visual analog scale (VAS) was used to evaluate pain during the postoperative follow-up period. It consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the no pain and 10 being the worst pain.