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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06210789
Other study ID # Epulis
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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