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Recruiting NCT06210789

NCT06210789 Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements

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Clinical Trial Summary
NCT ID NCT06210789
Status Recruiting
Phase
Sponsor Semmelweis University
Condition Localized Gingival Enlargement
Study Type INTERVENTIONAL
Enrollment 22 participants
Start Date 2024-01-05
Primary Completion 2025-12

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Surgical excision

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 22 participants in total. It began in 2024-01-05 with a primary completion date of 2025-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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)

Contact & Investigator

Central Contact

Bálint Molnár

✉ molbal81@gmail.com

📞 +36 1 318 5222

Principal Investigator

Bálint Molnár

PRINCIPAL INVESTIGATOR

Semmelweis University

Frequently Asked Questions

Who can join the NCT06210789 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Localized Gingival Enlargement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06210789 currently recruiting?

Yes, NCT06210789 is actively recruiting participants. Contact the research team at molbal81@gmail.com for enrollment information.

Where is the NCT06210789 trial being conducted?

This trial is being conducted at Budapest, Hungary.

Who is sponsoring the NCT06210789 clinical trial?

NCT06210789 is sponsored by Semmelweis University. The principal investigator is Bálint Molnár at Semmelweis University. The trial plans to enroll 22 participants.

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