Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03539939
Enrollment
15
Registered
2018-05-30
Start date
2010-05-03
Completion date
2013-01-07
Last updated
2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession, Smoking

Keywords

Gingival crevicular fluid, Gingival recession, Saliva, Smoking, Wound healing

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.

Interventions

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.

Sponsors

University of Louisville
CollaboratorOTHER
Ege University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the percentage of root coverage1-month, 3-month and 6-month after coronally advanced flap (CAF)Root coverage were measured on digital photographs using specific software.

Secondary

MeasureTime frameDescription
Change in the percentage of complete root coverage1-month, 3-month and 6-month after coronally advanced flap (CAF)
Change in gingival thicknessBaseline,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) biomarkersBaseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Changing of the salivary biomarkersBaseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Change in the visual analog scale (VAS) values1 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026