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Completed

NCT Number: NCT04410614

Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites

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.

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Key information

Conditions

Keratinized Mucosa

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Implantologia Cirugia Oral y Maxilofacial

Badajoz, 06011, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free epithelial (gingival) graft

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

Primary outcomes

  1. Change in keratinized mucosa

    Time frame: 3 weeks, 3 months, 6 months follow-up

    Area of keratinized mucosa gain

Secondary outcomes

  1. Factor 1 affecting the dimensional changes

    Time frame: 3 weeks, 3 months, 6 months

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

  2. Factor 2 affecting the dimensional changes

    Time frame: 3 weeks, 3 months, 6 months

    Thickness in mm of the graft

  3. Factor 3 affecting the dimensional changes

    Time frame: 3 weeks, 3 months, 6 months

    Thickness in mm of the recipient connective tissue

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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