Oral Pyogenic GranulomaPhase 2/3NCT05534334
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.
A Phase 2/3 study testing Solu-Cortef in people with Oral Pyogenic Granuloma, run by Beni-Suef University at 2 sites in Egypt.
Trial summary
Gingival Pyogenic granuloma in the esthetic zone represents an esthetic problem. While surgical treatment may not give the premium esthetic demands, corticosteroid may acheive this balance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Pyogenic Granuloma
- What is being tested?
- Solu-Cortef
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2022to 29 Nov 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with oral pyogenic granuloma at the esthetic zone
Who cannot join
- Patients who were not compliant to oral hygiene instructions and can not be motivated
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Beni_Suef University
Banī Suwayf, Beni Suweif Governorate, 1172
Eman Magsy, Lecturer, 01001077882, emanmagdy@dent.bsu.edu.eg
- Recruiting
Eman Ahmed
Banī Suwayf, Benisuef, 1178
Eman Ahmed, PhD, 01001077882, emanmagdy@dent.bsu.edu.eg
About this study
Official title: Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone
Gingival Pyogenic granuloma in the esthetic zone represents an esthetic problem. While surgical treatment may not give the premium esthetic demands, corticosteroid may acheive this balance.
Read the detailed description
In our practice, the investigators have found the use of topical steroids effectively induced regression of PGs. This protocol has been suggested by published case reports supported by the anti-inflammatory actions corticosteroid.
This is a particularly valuable approach for patients who have PG in the esthetic zone allowing the surgeon to keep maximum amount of periodontal tissues.
- Conditions
- Oral Pyogenic Granuloma
- Being tested
- Solu-Cortef
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solu-CortefDrug
Also called Hydrocortisone
A vial sol. used for intra-mascular injection
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Surgical excision of the gingival pyogenic granuloma Receives: Drug: Solu-Cortef |
| Intervention | Experimental | Intralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone) Receives: Drug: Solu-Cortef |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remaining width of the attached gingiva
Remaining width of the attached gingival it is measured using graduated probe
Measured: 6 month
Secondary outcomes (1)
Recurrence of the lesion
Assessed as clinical reoccurrence of the lesion at the same site
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 May 2022
- Primary completion29 Nov 2022 (estimated)
- Study completion29 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Pyogenic GranulomaStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Magdy Ahmed, Beni-Suef University
- Investigators
- Eman Magdy, PhD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534334
- Sponsor's protocol ID
- 17/4/21
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone
- ClinicalTrials.gov ID
- NCT05534334
- Acronym / sponsor ID
- 17/4/21
- Conditions
- Oral Pyogenic Granuloma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 29 Nov 2022 (estimated)
- Study completion
- 29 Nov 2022 (estimated)
- First posted
- 9 Sep 2022 (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.
Gingival Pyogenic granuloma in the esthetic zone represents an esthetic problem. While surgical treatment may not give the premium esthetic demands, corticosteroid may acheive this balance.
Detailed description
In our practice, the investigators have found the use of topical steroids effectively induced regression of PGs. This protocol has been suggested by published case reports supported by the anti-inflammatory actions corticosteroid.
This is a particularly valuable approach for patients who have PG in the esthetic zone allowing the surgeon to keep maximum amount of periodontal tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: Solu-CortefSurgical excision of the gingival pyogenic granuloma |
| Intervention | Experimental | Drug: Solu-CortefIntralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with oral pyogenic granuloma at the esthetic zone
Key exclusion criteria (1 listed)
- Patients who were not compliant to oral hygiene instructions and can not be motivated
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 |
|---|---|---|
| Solu-CortefAlso: HydrocortisoneA vial sol. used for intra-mascular injection | Drug | Control arm, Intervention |
Primary outcome
Remaining width of the attached gingiva
Time frame: 6 month
Remaining width of the attached gingival it is measured using graduated probe
1 secondary outcome
Recurrence of the lesion
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Eman Magdy, PhD principal investigator
Lecturer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Solu-Cortef in people with Oral Pyogenic Granuloma, run by Beni-Suef University at 2 sites in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Magdy, PhD (01001077882, emysanfora82@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remaining width of the attached gingiva (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2022.