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Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites

Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain (Other)
Overall Status
Completed
CT.gov ID
NCT04410614
Collaborator
(none)
54
Enrollment
1
Location
1
Arm
13.2
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For the management of peridontal and peri-implant conditions, free epithelial grafts have been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing confort during brushing and reducing the level of inflammation. Nevertheless, these are subjected to dimensional changes that may jeopardise the final outcome of providing sufficient keratinized mucosa to teeth and implants. Hence, this prospective study will aim at shedding light on the dimensional changes and the variables affecting these changes.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Free epithelial (gingival) graft
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Teeth and implants receiving free epithelial grafts harvested from the palateTeeth and implants receiving free epithelial grafts harvested from the palate
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites: A Prospective Clinical Study
Actual Study Start Date :
May 25, 2020
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Free epithelial graft

Free epithelial graft at implant and teeth sites to increase the band of keratinized mucosa

Procedure: Free epithelial (gingival) graft
1mm thickness epithelial layer harvested from the palate (1st molar area) is grafted and stabilised at the dental or implant area deficient of keratinized mucosa

Outcome Measures

Primary Outcome Measures

  1. Change in keratinized mucosa [3 weeks, 3 months, 6 months follow-up]

    Area of keratinized mucosa gain

Secondary Outcome Measures

  1. Factor 1 affecting the dimensional changes [3 weeks, 3 months, 6 months]

    Avascular area exposed to the graft (implant/tooth surface)

  2. Factor 2 affecting the dimensional changes [3 weeks, 3 months, 6 months]

    Thickness in mm of the graft

  3. Factor 3 affecting the dimensional changes [3 weeks, 3 months, 6 months]

    Thickness in mm of the recipient connective tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patients in need of keratinized mucosa to improve the periodontal and peri-implant condition

  • With no uncontrolled disease

  • Non-smokers

Exclusion Criteria:

  • Patients with uncontrolled diseases and conditions

  • Smokers

  • Patients with sufficient keratinized mucosa

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro de Implantologia Cirugia Oral y Maxilofacial Badajoz Spain 06011

Sponsors and Collaborators

  • Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alberto Monje, Head of Division of Periodontology, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
ClinicalTrials.gov Identifier:
NCT04410614
Other Study ID Numbers:
  • 21052020
First Posted:
Jun 1, 2020
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 10, 2021