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Clinical Trials/NCT02659904
NCT02659904
Completed
Early Phase 1

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

İlker KESKINER0 sites40 target enrollmentFebruary 2015

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Healthy
Sponsor
İlker KESKINER
Enrollment
40
Primary Endpoint
Change in remaining palatal tissue thickness
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
İlker KESKINER
Responsible Party
Sponsor Investigator
Principal Investigator

İlker KESKINER

Principal Investigator

Ondokuz Mayıs University

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.

Outcomes

Primary Outcomes

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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