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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Gingival Recession
• Intervention / Treatment: Procedure: Coronally Advanced Flap

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoker Group; This group included smoker gingival recession patients.	Procedure: 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.
Active Comparator: Non-smoker Group; This group included non-smoker gingival recession patients.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the percentage of complete root coverage		1-month, 3-month and 6-month after coronally advanced flap (CAF)
Change in gingival thickness	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.	Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
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	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.	1 to 7 day after coronally advanced flap (CAF)

Collaborators and Investigators

• Sponsor: Ege University
• Collaborators: University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2010
• Primary Completion (Actual): June 7, 2012
• Study Completion (Actual): January 7, 2013

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Smoking; Gingival recession; Wound healing; Saliva; Gingival crevicular fluid
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 2010-DIS-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No