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

NCT ID: NCT02659904

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-01-31

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).

Conditions

Healthy; Gingival Recession

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Less than 2 mm remaining palatal tissue thickness

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

2 mm or more remaining palatal tissue thickness

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

İlker KESKINER

OTHER

Sponsor Role: lead

Responsible Party

İlker KESKINER

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 27330024 (View on PubMed)

Other Identifiers

2015/103

Identifier Type: -

Identifier Source: org_study_id