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

Primary Purpose

Healthy, Gingival Recession

Status

Completed

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Less than 2 mm remaining palatal tissue thickness

2 mm or more remaining palatal tissue thickness

About this trial

This is an interventional treatment trial for Healthy focused on measuring Free gingival graft, Palatal donor site healing

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Less than 2 mm

2 mm or more

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in remaining palatal tissue thickness

Secondary Outcome Measures

Full Information

NCT ID

NCT02659904

First Posted

January 14, 2016

Last Updated

January 16, 2016

Sponsor

İlker KESKINER

1. Study Identification

Unique Protocol Identification Number

NCT02659904

Brief Title

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

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

İlker KESKINER

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Gingival Recession

Keywords

Free gingival graft, Palatal donor site healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Less than 2 mm

Arm Type

Active Comparator

Arm Description

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

Arm Title

2 mm or more

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Less than 2 mm remaining palatal tissue thickness

Intervention Description

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

Intervention Name(s)

2 mm or more remaining palatal tissue thickness

Intervention Description

Primary Outcome Measure Information:

Title

Change in remaining palatal tissue thickness

Time Frame

From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

27330024

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.

Results Reference

derived

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

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