Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
ConditionInsufficient Keratinized Gingiva
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiruni University
About this trial
The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:
Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?
Our study consists of 2 groups:
The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).
The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).
Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Periodontal and peri-implant tissue health
Good oral hygiene (plaque accumulation <20%)
Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery <2 mm keratinized gingiva on the vestibular side of the implant
No systemic disease and medication use that may affect soft tissue healing.
Disqualifiers
Systemic disease that is a contraindication to the surgical procedure,
Uncontrolled diabetes (HbA1c > 7),
Being pregnant or breastfeeding,
Autoimmune and/or inflammatory diseases of the oral cavity,
Trial design
Design model
Parallel
Treatments tested in this trial
Free gingival graft
Procedure/SurgeryAfter adequate local anesthesia is achieved, a horizontal incision will be placed at mucogingival junction level to prepare the recipient bed. A split-thickness flap will be raised without disturbing the periosteum. A free gingival graft will be obtained from the palate. The graft will be shaped and sutured to the recipient surface.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: smokerExperimental treatment 1 intervention
Group B: non-smokerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The three-dimensional changes of free gingival graft
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Time frame
Baseline2
The three-dimensional changes of free gingival graft.
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Time frame
1st month3
The three-dimensional changes of free gingival graft
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Time frame
3rd month4
The three-dimensional changes of free gingival graft
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Time frame
6th monthSecondary outcomes
1
Plaque index
0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Time frame
Baseline2
Plaque index
0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Time frame
1st month3
Plaque index
0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Time frame
3rd month4
Plaque index
0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Time frame
6th monthSponsors and contacts
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Source ClinicalTrials.gov