Back to resultsThe Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
Primary Purpose
Gingival Recession, Smoking
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coronally Advanced Flap
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Gingival crevicular fluid, Gingival recession, Saliva, Smoking, Wound healing
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smoker Group
Non-smoker Group
Arm Description
This group included smoker gingival recession patients.
This group included non-smoker gingival recession patients.
Outcomes
Primary Outcome Measures
Change in the percentage of root coverage
Root coverage were measured on digital photographs using specific software.
Secondary Outcome Measures
Change in the percentage of complete root coverage
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.
Changing of the gingival crevicular fluid (GCF) biomarkers
Changing of the salivary biomarkers
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.
Full Information
NCT ID
NCT03539939
First Posted
May 15, 2018
Last Updated
May 25, 2018
Sponsor
Ege University
Collaborators
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT03539939
Brief Title
The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
Official Title
The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 3, 2010 (Actual)
Primary Completion Date
June 7, 2012 (Actual)
Study Completion Date
January 7, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
Collaborators
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Smoking
Keywords
Gingival crevicular fluid, Gingival recession, Saliva, Smoking, Wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smoker Group
Arm Type
Experimental
Arm Description
This group included smoker gingival recession patients.
Arm Title
Non-smoker Group
Arm Type
Active Comparator
Arm Description
This group included non-smoker gingival recession patients.
Intervention Type
Procedure
Intervention Name(s)
Coronally Advanced Flap
Intervention Description
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 Outcome Measure Information:
Title
Change in the percentage of root coverage
Description
Root coverage were measured on digital photographs using specific software.
Time Frame
1-month, 3-month and 6-month after coronally advanced flap (CAF)
Secondary Outcome Measure Information:
Title
Change in the percentage of complete root coverage
Time Frame
1-month, 3-month and 6-month after coronally advanced flap (CAF)
Title
Change in gingival thickness
Description
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.
Time Frame
Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Title
Changing of the gingival crevicular fluid (GCF) biomarkers
Time Frame
Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Title
Changing of the salivary biomarkers
Time Frame
Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Title
Change in the visual analog scale (VAS) values
Description
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.
Time Frame
1 to 7 day after coronally advanced flap (CAF)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
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