Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
1 active site
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
May 25, 2020
CompletedFirst Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedSeptember 10, 2021
September 1, 2021
1.1 years
May 27, 2020
September 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in keratinized mucosa
Area of keratinized mucosa gain
3 weeks, 3 months, 6 months follow-up
Secondary Outcomes (3)
Factor 1 affecting the dimensional changes
3 weeks, 3 months, 6 months
Factor 2 affecting the dimensional changes
3 weeks, 3 months, 6 months
Factor 3 affecting the dimensional changes
3 weeks, 3 months, 6 months
Study Arms (1)
Free epithelial graft
EXPERIMENTALFree epithelial graft at implant and teeth sites to increase the band of keratinized mucosa
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients in need of keratinized mucosa to improve the periodontal and peri-implant condition
- With no uncontrolled disease
- Non-smokers
You may not qualify if:
- Patients with uncontrolled diseases and conditions
- Smokers
- Patients with sufficient keratinized mucosa
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Implantologia Cirugia Oral y Maxilofacial
Badajoz, 06011, Spain
Related Publications (2)
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.
PMID: 30461016BACKGROUNDMonje 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.
PMID: 34970744DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Division of Periodontology
Study Record Dates
First Submitted
May 27, 2020
First Posted
June 1, 2020
Study Start
May 25, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
September 10, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share