Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites

September 9, 2021 updated by: Alberto Monje, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites: A Prospective Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06011
        • Centro de Implantologia Cirugia Oral y Maxilofacial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in keratinized mucosa
Time Frame: 3 weeks, 3 months, 6 months follow-up
Area of keratinized mucosa gain
3 weeks, 3 months, 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factor 1 affecting the dimensional changes
Time Frame: 3 weeks, 3 months, 6 months
Avascular area exposed to the graft (implant/tooth surface)
3 weeks, 3 months, 6 months
Factor 2 affecting the dimensional changes
Time Frame: 3 weeks, 3 months, 6 months
Thickness in mm of the graft
3 weeks, 3 months, 6 months
Factor 3 affecting the dimensional changes
Time Frame: 3 weeks, 3 months, 6 months
Thickness in mm of the recipient connective tissue
3 weeks, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 21052020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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