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Recruiting NCT06210789

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

No phase Interventional Localized Gingival Enlargement Epulides Recurrence Periodontal; Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical excision.
Who it may be relevant to
Registry conditions: Localized Gingival Enlargement, Epulides, Recurrence, Periodontal; Lesion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.)

Interventions

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

Primary outcome measures

  • Recurrence [Time frame: 3 months, 6 months]
Secondary outcome measures (2)
  • Keratinized Gingiva Height [Time frame: 1 month, 3 months, 6 months]
  • Gingival Recession [Time frame: 1 month, 3 months, 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hungary · 1 center
  • Semmelweis University, Faculty of Dentistry — Budapest

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. PMID 37081478

Identifiers

NCT: NCT06210789 · Epulis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗