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RecruitingNCT06210789Updated Apr 4, 2025

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

An interventional study of Surgical excision in Localized Gingival Enlargement, Epulides and Recurrence, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Semmelweis University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.)

02

Conditions studied

  • Localized Gingival Enlargement
  • Epulides
  • Recurrence
  • Periodontal; Lesion

Keywords

  • Periodontal reconstructive surgery
  • Surgical excision
  • Surgical treatment
  • Localized Gingival Enlargement
03

In context

Gingival Diseases

88 studies on the registry are indexed under Gingival Diseases; 23 are open to participants now.

This study's planned enrollment of 22 is below the median of 46 across 69 interventional studies indexed under Gingival Diseases.

Browse Gingival Diseases studies →

Lead sponsor

Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnant women
  • medication intake that can potentially affect the oral mucosa and its healing
  • heavy smokers (>=15)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Surgical treatment

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

    Procedure: Surgical excision

Interventions

  • ProcedureSurgical excision

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

    Also known as: periodontal plastic reconstruction

06

What researchers measure

Primary outcomes

  1. Recurrence

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

    Time frame: 3 months, 6 months

Secondary outcomes

  1. Keratinized Gingiva Height

    The height of the remaining keratinized gingiva

    Time frame: 1 month, 3 months, 6 months

  2. Gingival Recession

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

    Time frame: 1 month, 3 months, 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 37081478 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06210789
Responsible party
Balint Molnar (Associate professor, Semmelweis University) — Principal investigator
First posted
Jan 18, 2024
Start date
Jan 5, 2024
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Apr 4, 2025

Study contacts

Bálint Molnár
Contact
molbal81@gmail.com
+36 1 318 5222
Andrea Dobos
Contact
andobos@ucm.es
+36309532140
Bálint Molnár
principal investigator · Semmelweis University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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