Pyogenic Granuloma of GingivaNCT05099081
Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma
A study testing diode laser application and intra-lesional injection of ethanolamine oleate in people with Pyogenic Granuloma of Gingiva, run by Alexandria University at 1 site in Egypt.
Trial summary
To clinically assess the effectiveness of diode laser versus sclerotherapy in the treatment of oral pyogenic granuloma. A randomized-controlled clinical trial conducted on 20 patients with oral pyogenic granuloma. Patients were assigned into two groups. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pyogenic Granuloma of Gingiva
- What is being tested?
- diode laser application and intra-lesional injection of ethanolamine oleate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Dec 2020to 9 Sep 2021
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both genders diagnosed clinically and confirmed histologically with oral pyogenic granuloma.
- Size of the lesion not less than 5mm.
- Patients included in the study will be having gingival pyogenic granuloma as it is the most common site for its occurrence.
- Patient age ranges from 19 to 50 years old.
Who cannot join
- Patients with uncontrolled diabetes.
- Immuno-compromised patients.
- Patients with renal disease.
- Patients having coagulation disorders.
- Patients having allergic reaction to any of the sclerosing drug constituents.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Diode Laser Versus Sclerotherapy in the Treatment of Oral Pyogenic Granuloma: a Randomized-controlled Clinical Trial
To clinically assess the effectiveness of diode laser versus sclerotherapy in the treatment of oral pyogenic granuloma.
A randomized-controlled clinical trial conducted on 20 patients with oral pyogenic granuloma. Patients were assigned into two groups. Group I treated by diode laser1; group II treated by injection of ethanolamine oleate2 as sclerosing agent. All patients were clinically assessed for pain, bleeding during surgery and healing quality; 1st week, 2nd week and 4th week. The patients were followed up after 3 months from the end of treatment.
Read the detailed description
Background: Pyogenic granuloma (PG) is one of the most common reactive hyperplasia that causes soft tissue enlargement. It affects skin and oral mucosa. The traditional treatment for oral PG is conservative surgical excision with cold blade together with the removal of causative irritant or source of trauma. Bleeding susceptibility, healing quality and pain represent common complications following surgical excision of pyogenic granuloma. Sclerosing agents are widely used in the treatment of pyogenic granuloma as it is a conservative non painful procedure. The use of lasers in dentistry have grown in the last 4 decades. It has proved its efficacy in the treatment of pyogenic granuloma.
Study objective: Study will be conducted to evaluate healing quality of using diode laser versus sclerotherapy (Ethanolamine oleate) in the treatment of oral pyogenic granuloma.
Materials and Method: This randomized controlled clinical trial will include 20 patients with pyogenic granuloma, divided equally into two groups. Group-I (test group) will be managed by application of diode laser. Group- II (control group) will be managed by injection of ethanolamine oleate as sclerosing agent on weekly injection visits. Patients of both groups will be evaluated intraoperatively for bleeding severity and postoperatively in terms of pain at the 2nd and 7th day and healing quality.
Results: Results will be tabulated and statistically analysed.
- Conditions
- Pyogenic Granuloma of Gingiva
- Being tested
- diode laser application, intra-lesional injection of ethanolamine oleate
- Keywords
- Pyogenic granuloma, Diode laser, Sclerotherapy, Ethanolamine oleate
- Medical subject headings
- Granuloma, Pyogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laser applicationProcedure or surgery
Local anesthesia will be applied Lesion will be excised with diode laser (Medency, Italy) continuous wave mode 980 nm wave length with an output power 3 W in contact mode
intra-lesional injection of ethanolamine oleateProcedure or surgery
Local anesthesia will be applied Injection of ethanolamine oleate (sclerosing gent) with concentration 5% diluted in distilled water to form 2.5% ethanolamine oleate According to lesion size range from 1.5 to 3 ml of solution will be injected slowly into lesion using gauge needle until leaked from lesion.
Lesion will be compressed for 5 minutes. Lesion will be observed once a week after injection until it becomes necrotic and falls off spontaneously.
Repeated injection may be needed.
| Study group | Role | What they receive |
|---|---|---|
| diode laser | Experimental | diode laser application Receives: Procedure: diode laser application |
| sclerotherapy | Active comparator | intra-lesional injection of ethanolamine oleate Receives: Procedure: intra-lesional injection of ethanolamine oleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Mild: Subsides at 20 min after applying pressure with gauze. Moderate: Requires haemostatic irrigation. Severe: Needs suturing and might need vitamin K administration or fresh frozen plasma infusion.
Measured: at baseline
Change in pain score
Postoperative pain will be evaluated at 2nd and 7th day using numeric rating scale (NRS) 0 = no pain. 1-3 = mild pain. 4-6 = moderate pain. 7-10 = severe pain.
Measured: at 2nd and 7th day
Change in healing quality index
Will be measured according to landry classification
- = very poor
- = poor
- = good
- = very good
- = excellent
Measured: at 1st week, 2nd week ,4th week and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start4 Dec 2020
- Primary completion1 Sep 2021
- Study completion9 Sep 2021
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 Alexandria 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra N. Edward, B.D, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099081
- Sponsor's protocol ID
- IORG0008839
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diode Laser Versus Sclerotherapy in the Treatment of Oral Pyogenic Granuloma: a Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05099081
- Acronym / sponsor ID
- IORG0008839
- Conditions
- Pyogenic Granuloma of Gingiva
- Keywords
- Pyogenic granuloma, Diode laser, Sclerotherapy, Ethanolamine oleate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 29 Oct 2021 (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.
To clinically assess the effectiveness of diode laser versus sclerotherapy in the treatment of oral pyogenic granuloma.
A randomized-controlled clinical trial conducted on 20 patients with oral pyogenic granuloma. Patients were assigned into two groups. Group I treated by diode laser1; group II treated by injection of ethanolamine oleate2 as sclerosing agent. All patients were clinically assessed for pain, bleeding during surgery and healing quality; 1st week, 2nd week and 4th week. The patients were followed up after 3 months from the end of treatment.
Detailed description
Background: Pyogenic granuloma (PG) is one of the most common reactive hyperplasia that causes soft tissue enlargement. It affects skin and oral mucosa. The traditional treatment for oral PG is conservative surgical excision with cold blade together with the removal of causative irritant or source of trauma. Bleeding susceptibility, healing quality and pain represent common complications following surgical excision of pyogenic granuloma. Sclerosing agents are widely used in the treatment of pyogenic granuloma as it is a conservative non painful procedure. The use of lasers in dentistry have grown in the last 4 decades. It has proved its efficacy in the treatment of pyogenic granuloma.
Study objective: Study will be conducted to evaluate healing quality of using diode laser versus sclerotherapy (Ethanolamine oleate) in the treatment of oral pyogenic granuloma.
Materials and Method: This randomized controlled clinical trial will include 20 patients with pyogenic granuloma, divided equally into two groups. Group-I (test group) will be managed by application of diode laser. Group- II (control group) will be managed by injection of ethanolamine oleate as sclerosing agent on weekly injection visits. Patients of both groups will be evaluated intraoperatively for bleeding severity and postoperatively in terms of pain at the 2nd and 7th day and healing quality.
Results: Results will be tabulated and statistically analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diode laser | Experimental | Procedure: diode laser applicationdiode laser application |
| sclerotherapy | Active comparator | Procedure: intra-lesional injection of ethanolamine oleateintra-lesional injection of ethanolamine oleate |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of both genders diagnosed clinically and confirmed histologically with oral pyogenic granuloma.
- Size of the lesion not less than 5mm.
- Patients included in the study will be having gingival pyogenic granuloma as it is the most common site for its occurrence.
- Patient age ranges from 19 to 50 years old.
Key exclusion criteria (6 listed)
- Patients with uncontrolled diabetes.
- Immuno-compromised patients.
- Patients with renal disease.
- Patients having coagulation disorders.
- Patients having allergic reaction to any of the sclerosing drug constituents.
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 |
|---|---|---|
| diode laser applicationLocal anesthesia will be applied Lesion will be excised with diode laser (Medency, Italy) continuous wave mode 980 nm wave length with an output power 3 W in contact mode | Procedure or surgery | diode laser |
| intra-lesional injection of ethanolamine oleateLocal anesthesia will be applied Injection of ethanolamine oleate (sclerosing gent) with concentration 5% diluted in distilled water to form 2.5% ethanolamine oleate According to lesion size range from 1.5 to 3 ml of solution will be injected slowly into lesion using gauge needle until leaked from lesion. Lesion will be compressed for 5 minutes. Lesion will be observed once a week after injection until it becomes necrotic and falls off spontaneously. Repeated injection may be needed. | Procedure or surgery | sclerotherapy |
Primary outcome
Bleeding
Time frame: at baseline
Mild: Subsides at 20 min after applying pressure with gauze. Moderate: Requires haemostatic irrigation. Severe: Needs suturing and might need vitamin K administration or fresh frozen plasma infusion.
Change in pain score
Time frame: at 2nd and 7th day
Postoperative pain will be evaluated at 2nd and 7th day using numeric rating scale (NRS) 0 = no pain. 1-3 = mild pain. 4-6 = moderate pain. 7-10 = severe pain.
Change in healing quality index
Time frame: at 1st week, 2nd week ,4th week and 3rd month
Will be measured according to landry classification 1. = very poor 2. = poor 3. = good 4. = very good 5. = excellent
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 29 Oct 2021.
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.
Sandra N. Edward, B.D principal investigator
Alexandria 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 diode laser application and intra-lesional injection of ethanolamine oleate in people with Pyogenic Granuloma of Gingiva, run by Alexandria 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 4 inclusion and 6 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 29 Oct 2021. 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?
Bleeding (time frame: at baseline). 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 29 Oct 2021.