NCT02659904

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1 healthy

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

January 14, 2016

Last Update Submit

January 16, 2016

Conditions

HealthyGingival Recession

Keywords

Free gingival graftPalatal donor site healing

Outcome Measures

Primary Outcomes (1)

  • Change in remaining palatal tissue thickness

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

Study Arms (2)

Less than 2 mm

ACTIVE COMPARATOR

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

Other: Less than 2 mm remaining palatal tissue thickness

2 mm or more

ACTIVE COMPARATOR

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

Other: 2 mm or more remaining palatal tissue thickness

Interventions

Less than 2 mm remaining palatal tissue thicknessOTHER

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.

Less than 2 mm
2 mm or more remaining palatal tissue thicknessOTHER

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

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27330024DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 21, 2016

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

January 21, 2016

Record last verified: 2016-01