Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06210789

Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements

Non-inflammatory recessions and Miller class I-II-III. mucogingival defects after elimination of localized gingival enlargements are frequently encountered challenges in the daily practice. In Miller class II-III. recessions the lack of keratinized tissues often compromise the maintenance a proper oral hygiene, this can cause inflammation, which can result in further periodontal attachment loss. In the literature there are some approaches that aim at widening of keratinized tissues and root coverage at the same time, such as the subperiosteal envelope technique (SET) (Allen 1994) combined with a subepithelial connective tissue graft (SCTG) or a partially epithelialized connective tissue graft (PE-SCTG) (Stimmelmayr 2011). In the eradication of localized gingival enlargement postoperative complications following surgical removal, such as recurrence and subsequent gingival recessions as well as loss of keratinized tissues are commonly observed. Nevertheless, a state of the art comprehensive treatment approach has not been reported yet to overcome the above mentioned sequels. The aim of this study is to present a periodontal plastic surgical approach to definitively eliminate localized gingiva enlargements and to simultaneously correct consecutive Miller class I II-III. recessions, esthetic disturbances. (Ethical committee permission number: SE RKEB: 185/2020.)

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients older than 18 years
  • systematically healthy patients
  • localized gingival enlargement is present that involves maximum 3 teeth

Exclusion criteria

  • pregnant women
  • medication intake that can potentially affect the oral mucosa and its healing
  • heavy smokers (>=15)

Treatment and study plan

Surgical excision

Procedure

Periodontal plastic reconstruction of the subsequent soft tissue dehiscence after the surgical excision of the localized gingival enlargement

Other names: periodontal plastic reconstruction

Primary outcomes

  1. Recurrence

    Time frame: 3 months, 6 months

    If there is recurrence after the proper elimination of the enlargement and the one-staged reconstruction

Secondary outcomes

  1. Keratinized Gingiva Height

    Time frame: 1 month, 3 months, 6 months

    The height of the remaining keratinized gingiva

  2. Gingival Recession

    Time frame: 1 month, 3 months, 6 months

    The subsequent gingiva recession that remains after the elimination of the enlargement and the reconstruction of the soft tissue

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Dobos

CONTACT

[email protected]

+36309532140

Bálint Molnár

CONTACT

[email protected]

+36 1 318 5222

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Periodontal Plastic Surgical Approaches to Correct Recession and Lack of Keratinized Tissue After Elimination of Localized Gingival Enlargements - a Case Series

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2024
Registry last updated
Apr 4, 2025

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.

Published trials that share one or more normalized conditions with this study.