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

NCT ID: NCT06210789

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2025-12-31

Brief Summary

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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.)

Detailed Description

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Conditions

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Localized Gingival Enlargement Epulides Recurrence Periodontal; Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Case series
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical treatment

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

Group Type EXPERIMENTAL

Surgical excision

Intervention Type PROCEDURE

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

Interventions

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Surgical excision

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

Intervention Type PROCEDURE

Other Intervention Names

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periodontal plastic reconstruction

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Balint Molnar

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bálint Molnár

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

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Semmelweis University, Faculty of Dentistry

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Bálint Molnár

Role: CONTACT

+36 1 318 5222

Andrea Dobos

Role: CONTACT

+36309532140

Facility Contacts

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Bálint Molnár

Role: primary

+3613185222

Andrea Dobos

Role: backup

+36309532140

References

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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.

Reference Type BACKGROUND
PMID: 37081478 (View on PubMed)

Related Links

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Other Identifiers

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Epulis

Identifier Type: -

Identifier Source: org_study_id

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