Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites

NCT ID: NCT04410614

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Keratinized Mucosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Teeth and implants receiving free epithelial grafts harvested from the palate
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Free epithelial graft

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

Group Type EXPERIMENTAL

Free epithelial (gingival) graft

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Alberto Monje

Head of Division of Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro de Implantologia Cirugia Oral y Maxilofacial

Badajoz, , Spain

Site Status

Countries

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Spain

References

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Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7.

Reference Type BACKGROUND
PMID: 30461016 (View on PubMed)

Monje A, Blasi G, Amerio E, Sanz-Martin I, Nart J. Dimensional changes in free epithelialized gingival/mucosal grafts at tooth and implant sites: A prospective cohort study. J Periodontol. 2022 Jul;93(7):1014-1023. doi: 10.1002/JPER.21-0521. Epub 2022 Jan 25.

Reference Type DERIVED
PMID: 34970744 (View on PubMed)

Other Identifiers

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21052020

Identifier Type: -

Identifier Source: org_study_id

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