NCT05099081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

October 29, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

September 9, 2021

Last Update Submit

October 18, 2021

Conditions

Pyogenic Granuloma of Gingiva

Keywords

Pyogenic granulomaDiode laserSclerotherapyEthanolamine oleate

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    at 2nd and 7th day

  • Change in healing quality index

    Will be measured according to landry classification 1. = very poor 2. = poor 3. = good 4. = very good 5. = excellent

    at 1st week, 2nd week ,4th week and 3rd month

Study Arms (2)

diode laser

EXPERIMENTAL

diode laser application

Procedure: diode laser application

sclerotherapy

ACTIVE COMPARATOR

intra-lesional injection of ethanolamine oleate

Procedure: intra-lesional injection of ethanolamine oleate

Interventions

diode laser applicationPROCEDURE

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

diode laser
intra-lesional injection of ethanolamine oleatePROCEDURE

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.

sclerotherapy

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Granuloma, Pyogenic

Condition Hierarchy (Ancestors)

GranulomaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sandra N. Edward, B.D

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

October 29, 2021

Study Start

December 4, 2020

Primary Completion

September 1, 2021

Study Completion

September 9, 2021

Last Updated

October 29, 2021

Record last verified: 2021-09

Locations

EG(1)