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

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210789
• Other study ID #: Epulis
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Semmelweis University
• Contact: Bálint Molnár
• Phone: +36 1 318 5222
• Email: molbal81[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gingival Diseases
• Gingival Hyperplasia
• Gingival Hypertrophy
• Gingival Overgrowth
• Hypertrophy
• Periodontal; Lesion
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis University, Faculty of Dentistry	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	If there is recurrence after the proper elimination of the enlargement and the one-staged reconstruction	3 months, 6 months
Secondary	Keratinized Gingiva Height	The height of the remaining keratinized gingiva	1 month, 3 months, 6 months
Secondary	Gingival Recession	The subsequent gingiva recession that remains after the elimination of the enlargement and the reconstruction of the soft tissue	1 month, 3 months, 6 months

External Links

•   Institutional homepage