Clinical trial NCT02659904: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Gingival Recession
Keywords: Free gingival graft
Palatal donor site healing
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in remaining palatal tissue thickness
timeFrame: From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.