NCT06210789

Brief Summary

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.)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

January 8, 2024

Last Update Submit

April 1, 2025

Conditions

Localized Gingival EnlargementEpulidesRecurrencePeriodontal; Lesion

Keywords

Periodontal reconstructive surgerySurgical excisionSurgical treatmentLocalized Gingival Enlargement

Outcome Measures

Primary Outcomes (1)

  • Recurrence

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

    3 months, 6 months

Secondary Outcomes (2)

  • Keratinized Gingiva Height

    1 month, 3 months, 6 months

  • Gingival Recession

    1 month, 3 months, 6 months

Study Arms (1)

Surgical treatment

EXPERIMENTAL

Surgical excision and periodontal reconstruction according to the remaining amount of keratinized gingiva

Procedure: Surgical excision

Interventions

Surgical excisionPROCEDURE

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

Also known as: periodontal plastic reconstruction
Surgical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University, Faculty of Dentistry

Budapest, 1088, Hungary

RECRUITING

Related Publications (1)

  • Zhao N, Yesibulati Y, Xiayizhati P, He YN, Xia RH, Yan XZ. A large-cohort study of 2971 cases of epulis: focusing on risk factors associated with recurrence. BMC Oral Health. 2023 Apr 20;23(1):229. doi: 10.1186/s12903-023-02935-x.

    PMID: 37081478BACKGROUND

Related Links

MeSH Terms

Conditions

Gingival DiseasesRecurrence

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bálint Molnár

    Semmelweis University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bálint Molnár

CONTACT

+36 1 318 5222molbal81@gmail.com

Andrea Dobos

CONTACT

+36309532140andobos@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

January 5, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)