Skip to main content
OpenTrials
Completed

NCT Number: NCT03539939

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingival Recession Behavior Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Smoking Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

coronally advanced flap

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.

Primary outcomes

  1. Change in the percentage of root coverage

    Time frame: 1-month, 3-month and 6-month after coronally advanced flap (CAF)

    Root coverage were measured on digital photographs using specific software.

Secondary outcomes

  1. Change in the percentage of complete root coverage

    Time frame: 1-month, 3-month and 6-month after coronally advanced flap (CAF)

  2. Change in gingival thickness

    Time frame: 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.

  3. Changing of the gingival crevicular fluid (GCF) biomarkers

    Time frame: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)

  4. Changing of the salivary biomarkers

    Time frame: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)

  5. Change in the visual analog scale (VAS) values

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • University of Louisville

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
May 30, 2018
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.