Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease (BD)

April 8, 2019 updated by: Clair Sobhy Nagieb Botros, Cairo University

Active Control,Randomized,Double- Blinded Clinical Trial of BD

Laser therapy is increasingly showing promising results in dental field including oral ulcers.This trial will assess the usefulness of Diode Laser compared to corticosteroid on oral ulcers of patients diagnosed with Behcet's disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The enrolled patients will be divided randomly into two groups.one group will receive Diode Laser (power:100 milli Watt,wavelength:980 mmm, delivery system:biostimulation probe) and other group will receive topical corticosteroids(Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermaphor) four times daily.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients diagnosed with Behcet's Disease according to International Criteria for BD.
  • patients with active oral ulcers.
  • patients free from any visible oral lesions other than the oral ulcers of BD.
  • patients who agreed to take the supplied interventions.
  • patients who will agree to participate in the study.
  • patients who will accept to sign the informed consent.

Exclusion Criteria:

  • patients not physically able to participate in survey or clinical oral examination.
  • patients with organ or life-threatening disease.
  • patients with history of a severe or chronic medical condition including tuberculosis, hepatitis and human immunodeficiency virus.
  • patients under immunosuppressive drugs.
  • patients with organ transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Triamcinolone acetonide
Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.
Drug: Triamcinolone Acetonide
0.1 &5gm paste 4 times/day
Other Names:
  • Topical corticosteroid
Experimental: Diode laser
Diode laser 980 nm & 100mWatt.
Radiation: Diode laser 980nm&100 mWatt
Diode laser 980 nm &100 milli Watt.
Other Names:
  • Soft laser
  • Low level laser
  • Biostimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral ulcer activity index
Time Frame: One month
Composite index score (0-10)
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health - related quality of life
Time Frame: One month
Oral health impact profile - 14 (OHIP- 14)
One month
Pain associated with oral ulcer
Time Frame: One month
Visual analogue scale (0-10)
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Sherin Ali Hassan, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 25, 2019

Primary Completion (Anticipated)

May 25, 2019

Study Completion (Anticipated)

May 25, 2019

Study Registration Dates

First Submitted

December 1, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3:5:1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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