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Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma

Primary Purpose

Pyogenic Granuloma of Gingiva

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
diode laser application
intra-lesional injection of ethanolamine oleate
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyogenic Granuloma of Gingiva focused on measuring Pyogenic granuloma, Diode laser, Sclerotherapy, Ethanolamine oleate

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients of both genders diagnosed clinically and confirmed histologically with oral pyogenic granuloma.
  2. Size of the lesion not less than 5mm.
  3. Patients included in the study will be having gingival pyogenic granuloma as it is the most common site for its occurrence.
  4. Patient age ranges from 19 to 50 years old.

Exclusion Criteria:

  1. Patients with uncontrolled diabetes.
  2. Immuno-compromised patients.
  3. Patients with renal disease.
  4. Patients having coagulation disorders.
  5. Patients having allergic reaction to any of the sclerosing drug constituents.
  6. Pregnant and lactating women.

Sites / Locations

  • Faculty of dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

diode laser

sclerotherapy

Arm Description

diode laser application

intra-lesional injection of ethanolamine oleate

Outcomes

Primary Outcome Measures

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.
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.
Change in healing quality index
Will be measured according to landry classification = very poor = poor = good = very good = excellent

Secondary Outcome Measures

Full Information

First Posted
September 9, 2021
Last Updated
October 18, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05099081
Brief Title
Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma
Official Title
Effectiveness of Diode Laser Versus Sclerotherapy in the Treatment of Oral Pyogenic Granuloma: a Randomized-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyogenic Granuloma of Gingiva
Keywords
Pyogenic granuloma, Diode laser, Sclerotherapy, Ethanolamine oleate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diode laser
Arm Type
Experimental
Arm Description
diode laser application
Arm Title
sclerotherapy
Arm Type
Active Comparator
Arm Description
intra-lesional injection of ethanolamine oleate
Intervention Type
Procedure
Intervention Name(s)
diode laser application
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
intra-lesional injection of ethanolamine oleate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bleeding
Description
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.
Time Frame
at baseline
Title
Change in pain score
Description
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.
Time Frame
at 2nd and 7th day
Title
Change in healing quality index
Description
Will be measured according to landry classification = very poor = poor = good = very good = excellent
Time Frame
at 1st week, 2nd week ,4th week and 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra N. Edward, B.D
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma

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