Gingival RecessionNCT03539939
The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
A study testing Coronally Advanced Flap in people with Gingival Recession and Smoking, run by Ege University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Smoking
- What is being tested?
- Coronally Advanced Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2010to 7 Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
- Conditions
- Gingival Recession, Smoking
- Being tested
- Coronally Advanced Flap
- Keywords
- Gingival crevicular fluid, Gingival recession, Saliva, Smoking, Wound healing
- Medical subject headings
- Gingival Recession, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally Advanced FlapProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Smoker Group | Experimental | This group included smoker gingival recession patients. Receives: Procedure: Coronally Advanced Flap |
| Non-smoker Group | Active comparator | This group included non-smoker gingival recession patients. Receives: Procedure: Coronally Advanced Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of root coverage
Root coverage were measured on digital photographs using specific software.
Measured: 1-month, 3-month and 6-month after coronally advanced flap (CAF)
Secondary outcomes (5)
Change in the percentage of complete root coverage
Measured: 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.
Measured: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Changing of the gingival crevicular fluid (GCF) biomarkers
Measured: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Changing of the salivary biomarkers
Measured: 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.
Measured: 1 to 7 day after coronally advanced flap (CAF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start3 May 2010
- Primary completion7 Jun 2012
- Study completion7 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Louisville
- Responsible party
- Principal investigator, Nurcan Buduneli, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539939
- Sponsor's protocol ID
- 2010-DIS-004
- Status last verified
- May 2018
- First submitted
- 15 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
- ClinicalTrials.gov ID
- NCT03539939
- Acronym / sponsor ID
- 2010-DIS-004
- Conditions
- Gingival Recession, Smoking
- Keywords
- Gingival crevicular fluid, Gingival recession, Saliva, Smoking, Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- University of Louisville
- Study start
- 3 May 2010 (actual)
- Primary completion
- 7 Jun 2012 (actual)
- Study completion
- 7 Jan 2013 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoker Group | Experimental | Procedure: Coronally Advanced FlapThis group included smoker gingival recession patients. |
| Non-smoker Group | Active comparator | Procedure: Coronally Advanced FlapThis group included non-smoker gingival recession patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronally Advanced FlapThe 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. | Procedure or surgery | Non-smoker Group, Smoker Group |
Primary outcome
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.
5 secondary outcomes
Change in the percentage of complete root coverage
Time frame: 1-month, 3-month and 6-month after coronally advanced flap (CAF)
Change in gingival thickness
Time frame: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Changing of the gingival crevicular fluid (GCF) biomarkers
Time frame: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Changing of the salivary biomarkers
Time frame: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
Change in the visual analog scale (VAS) values
Time frame: 1 to 7 day after coronally advanced flap (CAF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally Advanced Flap in people with Gingival Recession and Smoking, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the percentage of root coverage (time frame: 1-month, 3-month and 6-month after coronally advanced flap (CAF)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.