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The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting

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ClinicalTrials.gov Identifier: NCT02659904
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
İlker KESKINER, Ondokuz Mayıs University

Tracking Information
First Submitted Date  ICMJE January 14, 2016
First Posted Date  ICMJE January 21, 2016
Last Update Posted Date January 21, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2016)
Change in remaining palatal tissue thickness [ Time Frame: From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
Official Title  ICMJE The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Gingival Recession
Intervention  ICMJE
  • Other: 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.
  • Other: 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.
Study Arms  ICMJE
  • 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
    Intervention: Other: Less than 2 mm remaining palatal tissue thickness
  • 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
    Intervention: Other: 2 mm or more remaining palatal tissue thickness
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2016)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02659904
Other Study ID Numbers  ICMJE 2015/103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party İlker KESKINER, Ondokuz Mayıs University
Study Sponsor  ICMJE İlker KESKINER
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ondokuz Mayıs University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP