The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
January 16, 2016 updated by: İlker KESKINER
Our primary objective in this clinical intervention study, therefore, was to explored the effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6 months after free gingival graft harvesting in order to determine as soon as possible to re-harvest gingival graft from same site.
Study Overview
Status
Completed
Conditions
Detailed Description
Forty individuals (19 males and 21 females; age range: 18-35 years) were enrolled in the study.
Based on the remaining tissue at donor site after free gingival graft harvesting, individuals were divided into two groups: 1.0-1.9
millimeter (mm) remaining tissue at donor site after harvesting (n = 20), 2-2.9 mm remaining tissue at donor site after harvesting.
Tissue filling in defect area from three points (mesial, central and distal) was measured at various time-points (baseline, post-operative 1, 3, 6 months).
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All individuals received oral hygiene instructions and full-mouth scaling was performed. -They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra-soft toothbrush
- Individuals were re-evaluated at 8 weeks after initial therapy, and only full mounth plaque score and full mounth bleeding score <15% were enrolled to the surgical procedure
- mucogingival defects which for soft tissue graft application were indicated
- For Less than 2 mm group, between 2.5 and 3.4 mm palatal thickness at each measurement points before graft harvesting
- For 2 mm or more group, between 3.5 and 4.4 mm palatal thickness at each measurement points before graft harvesting.
Exclusion Criteria:
- periapical or palatal pathologies,
- absence teeth from canine to first molar,
- excessive forces including mechanical forces from orthodontics and occlusion,
- systemic diseases that would contraindicate for periodontal surgery or interfere with tissue healing, chronic high-dose steroid therapy, radiation or immunosuppressive therapy, pregnancy, lactation, smoking, or allergy or sensitivity to any drug
- Study participants had no history of drug therapy known to interfere with healing and to cause gingival enlargement
- Individuals who had complication such as bleeding, necrosis and delay healing during or after surgery were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Less than 2 mm
Palatal mucosa thickness was measured from baseline to 1, 3 and 6 months after graft harvesting Intervention: Less than 2 mm remaining palatal tissue thickness
|
The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection.
After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.
|
|
Active Comparator: 2 mm or more
Palatal mucosa thickness was measured from baseline to 1, 3 and 6 months after graft harvesting Intervention: 2 mm or more remaining palatal tissue thickness
|
The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection.
After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in remaining palatal tissue thickness
Time Frame: From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months
|
From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
January 14, 2016
First Submitted That Met QC Criteria
January 16, 2016
First Posted (Estimate)
January 21, 2016
Study Record Updates
Last Update Posted (Estimate)
January 21, 2016
Last Update Submitted That Met QC Criteria
January 16, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/103
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