Back to results

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

Primary Purpose

Autoimmune, Behcet Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Diode laser 980nm&100 mWatt

Triamcinolone Acetonide

About this trial

This is an interventional treatment trial for Autoimmune focused on measuring Oral ulcers

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Triamcinolone acetonide

Diode laser

Arm Description

Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.

Diode laser 980 nm & 100mWatt.

Outcomes

Primary Outcome Measures

Oral ulcer activity index

Composite index score (0-10)

Secondary Outcome Measures

Oral health - related quality of life

Oral health impact profile - 14 (OHIP- 14)

Pain associated with oral ulcer

Visual analogue scale (0-10)

Full Information

NCT ID

NCT03771768

First Posted

December 1, 2018

Last Updated

April 8, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03771768

Brief Title

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

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 25, 2019 (Anticipated)

Primary Completion Date

May 25, 2019 (Anticipated)

Study Completion Date

May 25, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune, Behcet Syndrome

Keywords

Oral ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1

Masking

Care ProviderInvestigator

Masking Description

Double - blinded trial: Outcome assessor (CS) and Statistician. Participants couldn't be blinded because of the difference in the nature of interventions method of application.

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Triamcinolone acetonide

Arm Type

Active Comparator

Arm Description

Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.

Arm Title

Diode laser

Arm Type

Experimental

Arm Description

Diode laser 980 nm & 100mWatt.

Intervention Type

Radiation

Intervention Name(s)

Diode laser 980nm&100 mWatt

Other Intervention Name(s)

Low level laser, Biostimulation, Soft laser

Intervention Description

Diode laser 980 nm &100 milli Watt.

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide

Other Intervention Name(s)

Topical corticosteroid

Intervention Description

0.1 &5gm paste 4 times/day

Primary Outcome Measure Information:

Title

Oral ulcer activity index

Description

Composite index score (0-10)

Time Frame

One month

Secondary Outcome Measure Information:

Title

Oral health - related quality of life

Description

Oral health impact profile - 14 (OHIP- 14)

Time Frame

One month

Title

Pain associated with oral ulcer

Description

Visual analogue scale (0-10)

Time Frame

One month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clair Sobhy Nagieb, MSC

Phone

01222259819

Ext

Cairo U

Clair.nadieb@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Zaki S.Zaki, MSC

Phone

01224045116

drzaki95@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherin Ali Hassan, MD

Organizational Affiliation

Cairo University

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23622766

Citation

Prasad R S, Pai A. Assessment of immediate pain relief with laser treatment in recurrent aphthous stomatitis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Aug;116(2):189-93. doi: 10.1016/j.oooo.2013.02.011. Epub 2013 Apr 23.

Results Reference

background

PubMed Identifier

24488418

Citation

Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behcet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1.

Results Reference

background

PubMed Identifier

34212234

Citation

Nagieb CS, Harhash TA, Fayed HL, Ali S. Evaluation of diode laser versus topical corticosteroid in management of Behcet's disease-associated oral ulcers: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):697-704. doi: 10.1007/s00784-021-04047-8. Epub 2021 Jul 2.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs