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

Not Applicable

Recruiting

• Conditions: Epulides; Localized Gingival Enlargement; Recurrence; Periodontal; Lesion
• Interventions: Procedure: Surgical excision

• Registration Number: NCT06210789
• Lead Sponsor: Semmelweis University

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.)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-05
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical treatment	Surgical excision	Surgical excision and periodontal reconstruction according to the remaining amount of keratinized gingiva

Primary Outcome Measures

Name	Time	Method
Recurrence	3 months, 6 months	If there is recurrence after the proper elimination of the enlargement and the one-staged reconstruction

Secondary Outcome Measures

Name	Time	Method
Keratinized Gingiva Height	1 month, 3 months, 6 months	The height of the remaining keratinized gingiva
Gingival Recession	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

Trial Locations

Locations (1)

Semmelweis University, Faculty of Dentistry; 🇭🇺 Budapest, Hungary