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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539939
• Other study ID #: 2010-DIS-004
• Status: Completed
• Phase: N/A
• Start date: May 3, 2010
• Est. completion date: January 7, 2013

Study information

• Verified date: May 2018
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 7, 2013
• Est. primary completion date: June 7, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Smoking

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	University of Louisville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the percentage of complete root coverage		1-month, 3-month and 6-month after coronally advanced flap (CAF)
Secondary	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)
Secondary	Changing of the gingival crevicular fluid (GCF) biomarkers		Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Secondary	Changing of the salivary biomarkers		Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Secondary	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)