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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659904
• Other study ID #: 2015/103
• Status: Completed
• Phase: Phase 0
• First received: January 14, 2016
• Last updated: January 16, 2016
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession
• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ilker KESKINER

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in remaining palatal tissue thickness		From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months	No