Plasma Cell GingivitisPCGNCT05236322
Management of Plasma Cell Gingivitis by Two Surgical Techniques
An observational study of Plasma Cell Gingivitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Two surgical protocols for management of Plasma cell Ginigivitis; either by surgical enblock resection of cold laser resection Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Plasma Cell Gingivitis
- What is being tested?
- soft tissue laser
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 20 Jan 2022
- Phase
- Observational
- 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
Study population: Patient suffering from plasma cell gingivitis
Who may be able to join
- patients suffering from the plasma cell gingivitis
Who cannot join
- Patient not eligible for maxillofacial surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Plasma Cell Gingivitis by En-block Removal
Two surgical protocols for management of Plasma cell Ginigivitis; either by surgical enblock resection of cold laser resection
Read the detailed description
Tow groups will be included the first will have six cases and second will have six cases. the first will be treated by ordinary surgical resection and second will be removed using soft tissue laser.
- Conditions
- Plasma Cell Gingivitis
- Being tested
- soft tissue laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue laserDevice
Surgical laser used in excision purpose
| Study group | Role | What they receive |
|---|---|---|
| study group | Removal by soft tissue laser of the tumor Receives: Device: soft tissue laser | |
| control group | Removal by ordinary surgical scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete removal
complete removal of lesion with safety margin
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Jan 2022
- Primary completion10 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell GingivitisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Ain Shams University
- Investigators
- mohamed diaa, professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236322
- Sponsor's protocol ID
- 1232022
- Acronym
- PCG
- Status last verified
- Feb 2022
- First submitted
- 23 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes planning to share
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Plasma Cell Gingivitis by En-block Removal
- ClinicalTrials.gov ID
- NCT05236322
- Acronym / sponsor ID
- PCG / 1232022
- Conditions
- Plasma Cell Gingivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 11 Feb 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.
Two surgical protocols for management of Plasma cell Ginigivitis; either by surgical enblock resection of cold laser resection
Detailed description
Tow groups will be included the first will have six cases and second will have six cases. the first will be treated by ordinary surgical resection and second will be removed using soft tissue laser.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: soft tissue laserRemoval by soft tissue laser of the tumor |
| control group | – | –Removal by ordinary surgical scalpel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient suffering from plasma cell gingivitis
Key inclusion criteria (1 listed)
- patients suffering from the plasma cell gingivitis
Key exclusion criteria (1 listed)
- Patient not eligible for maxillofacial surgery
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 |
|---|---|---|
| soft tissue laserSurgical laser used in excision purpose | Device | study group |
Primary outcome
complete removal
Time frame: one month
complete removal of lesion with safety margin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: Undecided. yes planning to share
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.
mohamed diaa, professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Cell Gingivitis, run by Ain Shams University at 1 site 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: finished, as of the sponsor's last update on 11 Feb 2022. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete removal (time frame: one 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 11 Feb 2022.