Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus

NCT05951361 | Completed

• 1 other identifier: 0369-01/2022
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

this study evaluates the effect of diode laser in treatment of oral lichen planus.

Conditions

Erosive Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• change of pain from the base line to 12 weeks follow-up

  Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever

  base line, 6weeks and 12 weeks

Secondary Outcomes (1)

• change of clinical score of the lesion from the base line to 12 weeks follow-up

  base line, 6weeks and 12 weeks

Other Outcomes (1)

• change in lipid peroxidation marker malondialdehyde from the base line to 12 weeks follow-up o 10 points VAS

  base line, 6weeks and 12 weeks

Study Arms (2)

Kenacourt-A Orabase

ACTIVE COMPARATOR

the patients in this group received steroid therapy" Kenacourt-A Orabase" three times daily for 4 weeks. antifungal drug "miconazole oral gel" once daily for 1 week

Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"

980nm Diode Laser

ACTIVE COMPARATOR

the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions

Device: 980nm Diode Laser

Interventions

980nm Diode Laser DEVICE

300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions

980nm Diode Laser

0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" DRUG

three times daily for 4 weeks

Also known as: Kenacourt-A Orabase

Kenacourt-A Orabase

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient histologically diagnosed with erosive OLP based on WHO modified criteria 2003.
• Presence of painful erosive OLP lesions diagnosed by biopsy

You may not qualify if:

• Pregnant or breast-feeding women
• Patients currently treated for cancer with Chemotherapy or Radiotherapy
• Patient currently on Corticosteroid therapy or had this treatment on the past 3 months
• Those who had used Anti-inflammatory drugs topical or systemic in the last month
• the use of drugs related to Oral Lichenoid Lesions
• Presence of Amalgam restorations near the OLP lesions
• dysplasia in histopathological examination
• uncontrolled systemic diseases
• physical or mental abnormality which would interfere with or be affected by the study procedure
• Patients with skin lesion

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology

Alexandria, Alexandria Governorate, 21648, Egypt

Location

Related Publications (3)

• Cafaro A, Arduino PG, Massolini G, Romagnoli E, Broccoletti R. Clinical evaluation of the efficiency of low-level laser therapy for oral lichen planus: a prospective case series. Lasers Med Sci. 2014 Jan;29(1):185-90. doi: 10.1007/s10103-013-1313-6. Epub 2013 Apr 3.

  PMID: 23549680 BACKGROUND

• Dillenburg CS, Martins MA, Munerato MC, Marques MM, Carrard VC, Sant'Ana Filho M, Castilho RM, Martins MD. Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial. J Biomed Opt. 2014 Jun;19(6):068002. doi: 10.1117/1.JBO.19.6.068002.

  PMID: 24887747 BACKGROUND

• Mohamed RK, Elsayed NM, Mahmoud SA, Gaweesh YY. Photobiomodulation versus corticosteroid in the management of erosive oral lichen planus: a randomized controlled clinical trial. BMC Oral Health. 2024 Feb 17;24(1):246. doi: 10.1186/s12903-024-03976-6.

  PMID: 38365694 DERIVED

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Naguiba Mahmoud, Prof

  department of oral medicine, faculty of dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: the patients were randomly assigned to avoid bios.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 19, 2023
• Study Start: February 1, 2022
• Primary Completion: February 10, 2023
• Study Completion: April 10, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The submission of data requests can commence nine months after the article has been published, and the data will be available for up to 24 months. Extensions will be reviewed on a case-by-case basis.
• Access Criteria: Qualified researchers who are conducting independent scientific research may request access to trial IPD. Upon review and approval of a research proposal and Statistical Analysis Plan (SAP), and the execution of a Data Sharing Agreement (DSA), access will be granted. For additional information or to request access, please contact the data provider. Approval for the extension of access beyond the initial 24-month period will also be considered on a case-by-case basis.

Locations

EG (1)