Pyogenic Granuloma of GingivaNCT06639230
Effect of Laser and Sclerotic Agent in the Treatment of Oral Granuloma
A study testing laser therapy and Sclerotherapy in people with Pyogenic Granuloma of Gingiva, run by Assiut University.
Trial summary
Pyogenic granuloma is a common tumor-like growth of the oral cavity considered to be non-neoplastic in nature. They usually present as a reactive lesion occur in response to chronic and recurring tissue injury, in which capillaries are very prominent commonly seen arising from interdental gingiva. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pyogenic Granuloma of Gingiva
- What is being tested?
- laser therapy and Sclerotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 30 Jan 2025
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All the subjects were principally diagnosed based on history and clinical features such as oral pyogenic granuloma are selected for this study. Radiographic evaluation was also done to rule out any bony involvement.
- The sizes of participants' lesions were not less than 5 mm. • Age > 18 years
Who cannot join
- Patients were excluded if they had uncontrolled diabetes, renal diseases, coagulation disorders or were allergic to any of the sclerosing drug constituents. Immune-compromised patients and pregnant and lactating women were also excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Randomized Clinical Study on the Recurrence Rate of Gingival Pyogenic Granuloma Treated with Sclerotherapy Versus Diode Laser Therapy.
Pyogenic granuloma is a common tumor-like growth of the oral cavity considered to be non-neoplastic in nature. They usually present as a reactive lesion occur in response to chronic and recurring tissue injury, in which capillaries are very prominent commonly seen arising from interdental gingiva. Pyogenic granuloma may occur in all ages, with a peak age of incidence in the second decade of life, more common in young adult females, possibly because of vascular effects of female hormones.
Read the detailed description
Oral PG can be treated by conservative excision. Local irritants or the source of trauma must be eliminated to minimize the risk of recurrence. Although, surgical excision is considered a simple procedure, it might be complicated by several complications such as intraoperative bleeding, and postoperative infection that might delay the healing of the wound. Other treatment modalities such as laser, injection of sclerosing agents have been used.
Laser has proven to be an effective therapy for oral soft tissue pathologies. Moreover, its ability to perform precise incisions, better hemostasias, and less invasive procedures with less discomfort to patients have made it a preferred treatment option for several soft tissue lesions.
Sclerotherapy has been proposed as an effective method of treatment for pyogenic granuloma. Their mechanism of action is endothelial injury, inflammation, thrombosis, fibrosis, and final lesion destruction. Polidocanol is a widely used nonionic detergent sclerosant that was first developed as an anesthetic. It acts through endothelial overhydration, vascular injury, and closure.
- Conditions
- Pyogenic Granuloma of Gingiva
- Being tested
- laser therapy, Sclerotherapy
- Keywords
- pyogenic granuloma, laser therapy, sclerosing agent
- Medical subject headings
- Granuloma, Pyogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapyDevice
Laser-treated group (test group): This group consisted of ten patients treated using diode lasers. The diode laser was operated in continuous wave mode with an output power of 3 W in contact mode to excise the pyogenic granuloma. The tip was moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised.
SclerotherapyDrug
Sclerotherapy-treated group (control group): This group consisted of ten patients treated with injections of sclerosing agent. After anaesthetizing the surgical site with a local anesthetic agent, The lesion was injected with a 2.5% concentration until it leaked out from the surface, leading to necrosis and spontaneous detachment of the lesion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Laser-treated group | Active comparator | 10 patients will be treated by laser surgery to remove oral granuloma Receives: Device: laser therapy |
| Sclerotherapy-treated group (group 2) | Active comparator | This group was made up of ten patients who were treated with injections of sclerosing agent to remove pyogenic granuloma Receives: Drug: Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain was evaluated (NRS)
Postoperative pain intensity will be perceived on the 2nd and 7th days using the ten-point Numeric Rating Scale (NRS) interpreted as 0 grade (No pain), 1-3 grade (mild pain), 4-6 grade (moderate pain) and 7-10 grade (severe pain)
Measured: 3 months
Recurrence rate
Patients will be recalled monthly for 3 months after the end of treatment to evaluate if recurrent occur or not.
Measured: 3 months
Patient compliance (VAS).
compliance of patients will be assessed on a scale from 1 to 10
Measured: 3 months
Secondary outcomes (1)
Details of side effects
details of any side effect as bleeding, oedema, necrosis, infection after the procedure.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyogenic Granuloma of GingivaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- * group 1: This group was made up of ten patients treated using diode lasers with an output power of 3 W in the contact mode, the tip will be moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised. * group 2: This group was made up of ten patients who were treated with sclerosing agent after anaesthetizing the surgical site with a local anesthetic agent, the lesion will be injected with the sclerosing agent, diluted in distilled water, the solution is injected slowly into the lesion using a 23-gauge needle until it leaks out from the surface.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashwa Helaly Mohamed, Assiut University
- Investigators
- Ahmed Mortada Fikry, professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639230
- Sponsor's protocol ID
- oral recurrent granuloma
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Clinical Study on the Recurrence Rate of Gingival Pyogenic Granuloma Treated with Sclerotherapy Versus Diode Laser Therapy.
- ClinicalTrials.gov ID
- NCT06639230
- Acronym / sponsor ID
- oral recurrent granuloma
- Conditions
- Pyogenic Granuloma of Gingiva
- Keywords
- pyogenic granuloma, laser therapy, sclerosing agent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 15 Oct 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.
Pyogenic granuloma is a common tumor-like growth of the oral cavity considered to be non-neoplastic in nature. They usually present as a reactive lesion occur in response to chronic and recurring tissue injury, in which capillaries are very prominent commonly seen arising from interdental gingiva. Pyogenic granuloma may occur in all ages, with a peak age of incidence in the second decade of life, more common in young adult females, possibly because of vascular effects of female hormones.
Detailed description
Oral PG can be treated by conservative excision. Local irritants or the source of trauma must be eliminated to minimize the risk of recurrence. Although, surgical excision is considered a simple procedure, it might be complicated by several complications such as intraoperative bleeding, and postoperative infection that might delay the healing of the wound. Other treatment modalities such as laser, injection of sclerosing agents have been used.
Laser has proven to be an effective therapy for oral soft tissue pathologies. Moreover, its ability to perform precise incisions, better hemostasias, and less invasive procedures with less discomfort to patients have made it a preferred treatment option for several soft tissue lesions.
Sclerotherapy has been proposed as an effective method of treatment for pyogenic granuloma. Their mechanism of action is endothelial injury, inflammation, thrombosis, fibrosis, and final lesion destruction. Polidocanol is a widely used nonionic detergent sclerosant that was first developed as an anesthetic. It acts through endothelial overhydration, vascular injury, and closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * group 1: This group was made up of ten patients treated using diode lasers with an output power of 3 W in the contact mode, the tip will be moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised. * group 2: This group was made up of ten patients who were treated with sclerosing agent after anaesthetizing the surgical site with a local anesthetic agent, the lesion will be injected with the sclerosing agent, diluted in distilled water, the solution is injected slowly into the lesion using a 23-gauge needle until it leaks out from the surface.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Laser-treated group | Active comparator | Device: laser therapy10 patients will be treated by laser surgery to remove oral granuloma |
| Sclerotherapy-treated group (group 2) | Active comparator | Drug: SclerotherapyThis group was made up of ten patients who were treated with injections of sclerosing agent to remove pyogenic granuloma |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All the subjects were principally diagnosed based on history and clinical features such as oral pyogenic granuloma are selected for this study. Radiographic evaluation was also done to rule out any bony involvement.
- The sizes of participants' lesions were not less than 5 mm. • Age > 18 years
Key exclusion criteria (1 listed)
- Patients were excluded if they had uncontrolled diabetes, renal diseases, coagulation disorders or were allergic to any of the sclerosing drug constituents. Immune-compromised patients and pregnant and lactating women were also excluded from the study.
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 |
|---|---|---|
| laser therapyLaser-treated group (test group): This group consisted of ten patients treated using diode lasers. The diode laser was operated in continuous wave mode with an output power of 3 W in contact mode to excise the pyogenic granuloma. The tip was moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised. | Device | Group 1: Laser-treated group |
| SclerotherapySclerotherapy-treated group (control group): This group consisted of ten patients treated with injections of sclerosing agent. After anaesthetizing the surgical site with a local anesthetic agent, The lesion was injected with a 2.5% concentration until it leaked out from the surface, leading to necrosis and spontaneous detachment of the lesion. | Drug | Sclerotherapy-treated group (group 2) |
Primary outcome
Postoperative pain was evaluated (NRS)
Time frame: 3 months
Postoperative pain intensity will be perceived on the 2nd and 7th days using the ten-point Numeric Rating Scale (NRS) interpreted as 0 grade (No pain), 1-3 grade (mild pain), 4-6 grade (moderate pain) and 7-10 grade (severe pain)
Recurrence rate
Time frame: 3 months
Patients will be recalled monthly for 3 months after the end of treatment to evaluate if recurrent occur or not.
Patient compliance (VAS).
Time frame: 3 months
compliance of patients will be assessed on a scale from 1 to 10
1 secondary outcome
Details of side effects
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Percutaneous sclerotherapy for vascular malformations: a systematic reviewLink provided by the sponsor.
- treatment of intraoral pyogenic granuloma with diode laser 810-980 nm.Link provided by the sponsor.
- Oral pyogenic granuloma: Various concepts of etiopathogenesis.Link provided by the sponsor.
- Oral Pyogenic Granuloma with Sodium Tetra Decyl Sulphate: A Case Series.Link provided by the sponsor.
- 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.
Ahmed Mortada Fikry, professor principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy and Sclerotherapy in people with Pyogenic Granuloma of Gingiva, run by Assiut University.
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 2 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nashwa Helaly Mohamed, lecturer (+2001002226405, nashwahelaly@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain was evaluated (NRS) (time frame: 3 months). The study lists 3 primary outcomes in all. 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 15 Oct 2024.