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

Early Phase 1

Completed

• Conditions: Healthy; Gingival Recession
• Interventions: Other: Less than 2 mm remaining palatal tissue thickness; Other: 2 mm or more remaining palatal tissue thickness

• Registration Number: NCT02659904
• Lead Sponsor: İlker KESKINER

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 Timeline

• Study Start: 2015-02
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-16
• Last Update Submitted: 2016-01-16
• Study First Posted: 2016-01-21
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Less than 2 mm	Less than 2 mm remaining palatal tissue thickness	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
2 mm or more	2 mm or more remaining palatal tissue thickness	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

Primary Outcome Measures

Name	Time	Method
Change in remaining palatal tissue thickness	From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months