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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Gingival Recession Other: Less than 2 mm remaining palatal tissue thickness Other: 2 mm or more remaining palatal tissue thickness Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016
Arms and Interventions
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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
 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.
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in remaining palatal tissue thickness [ Time Frame: From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: İlker KESKINER, Principal Investigator, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT02659904    
Other Study ID Numbers: 2015/103
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by İlker KESKINER, Ondokuz Mayıs University:
Free gingival graft
Palatal donor site healing
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy