Localized Gingival EnlargementNCT06210789
Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements
A study testing Surgical excision in people with Localized Gingival Enlargement and Epulides, run by Semmelweis University at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Localized Gingival Enlargement, Epulides, Recurrence
- What is being tested?
- Surgical excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteHungary
- Study dates
- 5 Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients older than 18 years
- systematically healthy patients
- localized gingival enlargement is present that involves maximum 3 teeth
Who cannot join
- pregnant women
- medication intake that can potentially affect the oral mucosa and its healing
- heavy smokers (>=15)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Faculty of Dentistry
Budapest, 1088
Bálint Molnár, +3613185222, molbal81@gmail.com
Andrea Dobos, +36309532140, andobos@ucm.es
About this study
Official title: Periodontal Plastic Surgical Approaches to Correct Recession and Lack of Keratinized Tissue After Elimination of Localized Gingival Enlargements - a Case Series
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.)
- Being tested
- Surgical excision
- Keywords
- Periodontal reconstructive surgery, Surgical excision, Surgical treatment, Localized Gingival Enlargement
- Medical subject headings
- Gingival Diseases, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical excisionProcedure or surgery
Also called periodontal plastic reconstruction
Periodontal plastic reconstruction of the subsequent soft tissue dehiscence after the surgical excision of the localized gingival enlargement
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Experimental | Surgical excision and periodontal reconstruction according to the remaining amount of keratinized gingiva Receives: Procedure: Surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
If there is recurrence after the proper elimination of the enlargement and the one-staged reconstruction
Measured: 3 months, 6 months
Secondary outcomes (2)
Keratinized Gingiva Height
The height of the remaining keratinized gingiva
Measured: 1 month, 3 months, 6 months
Gingival Recession
The subsequent gingiva recession that remains after the elimination of the enlargement and the reconstruction of the soft tissue
Measured: 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start5 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Localized Gingival EnlargementStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case series
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balint Molnar, Semmelweis University
- Investigators
- Bálint Molnár, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210789
- Sponsor's protocol ID
- Epulis
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37081478
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Plastic Surgical Approaches to Correct Recession and Lack of Keratinized Tissue After Elimination of Localized Gingival Enlargements - a Case Series
- ClinicalTrials.gov ID
- NCT06210789
- Acronym / sponsor ID
- Epulis
- Keywords
- Periodontal reconstructive surgery, Surgical excision, Surgical treatment, Localized Gingival Enlargement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Experimental | Procedure: Surgical excisionSurgical excision and periodontal reconstruction according to the remaining amount of keratinized gingiva |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients older than 18 years
- systematically healthy patients
- localized gingival enlargement is present that involves maximum 3 teeth
Key exclusion criteria (3 listed)
- pregnant women
- medication intake that can potentially affect the oral mucosa and its healing
- heavy smokers (>=15)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical excisionAlso: periodontal plastic reconstructionPeriodontal plastic reconstruction of the subsequent soft tissue dehiscence after the surgical excision of the localized gingival enlargement | Procedure or surgery | Surgical treatment |
Primary outcome
Recurrence
Time frame: 3 months, 6 months
If there is recurrence after the proper elimination of the enlargement and the one-staged reconstruction
2 secondary outcomes
Keratinized Gingiva Height
Time frame: 1 month, 3 months, 6 months
Gingival Recession
Time frame: 1 month, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 37081478Zhao 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.
- Institutional homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Localized Gingival Enlargement
Active, not recruitingObservational study
Histological/ Immunohistological and Molecularpathological Types of Epulides and Central Giant Cell Lesions of the Jaws
Epulis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bálint Molnár principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical excision in people with Localized Gingival Enlargement and Epulides, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bálint Molnár (+36 1 318 5222, molbal81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06210789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.