Clinical trial NCT06210789: Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements
Official title: Periodontal Plastic Surgical Approaches to Correct Recession and Lack of Keratinized Tissue After Elimination of Localized Gingival Enlargements - a Case Series
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Localized Gingival Enlargement
Epulides
Recurrence
Periodontal; Lesion
Keywords: Periodontal reconstructive surgery
Surgical excision
Surgical treatment
Localized Gingival Enlargement
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series
Primary purpose: TREATMENT

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.)


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)

Primary outcomes:
measure: Recurrence
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Keratinized Gingiva Height
timeFrame: 1 month, 3 months, 6 months
measure: Gingival Recession
timeFrame: 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Faculty of Dentistry
Study officials:
affiliation: Semmelweis University
name: Bálint Molnár
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.