Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites

Keratinized Mucosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410614
• Other study ID #: 21052020
• Status: Completed
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2021
• Source: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratinized Mucosa

Intervention

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

Locations

Country	Name	City	State
Spain	Centro de Implantologia Cirugia Oral y Maxilofacial	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in keratinized mucosa	Area of keratinized mucosa gain	3 weeks, 3 months, 6 months follow-up
Secondary	Factor 1 affecting the dimensional changes	Avascular area exposed to the graft (implant/tooth surface)	3 weeks, 3 months, 6 months
Secondary	Factor 2 affecting the dimensional changes	Thickness in mm of the graft	3 weeks, 3 months, 6 months
Secondary	Factor 3 affecting the dimensional changes	Thickness in mm of the recipient connective tissue	3 weeks, 3 months, 6 months