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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

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).

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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

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.




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 ]


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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.
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