The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
Primary Purpose
Healthy, Gingival Recession
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Less than 2 mm remaining palatal tissue thickness
2 mm or more remaining palatal tissue thickness
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Free gingival graft, Palatal donor site healing
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Less than 2 mm
2 mm or more
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in remaining palatal tissue thickness
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02659904
Brief Title
The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
Official Title
The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
İlker KESKINER
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Gingival Recession
Keywords
Free gingival graft, Palatal donor site healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Less than 2 mm
Arm Type
Active Comparator
Arm Description
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
Arm Title
2 mm or more
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Less than 2 mm remaining palatal tissue thickness
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
2 mm or more remaining palatal tissue thickness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in remaining palatal tissue thickness
Time Frame
From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
27330024
Citation
Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.
Results Reference
derived
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The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
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