Effectiveness Of Photobiomodulation Therapy Compared to Triamcinolone Acetonide in Treating Oral Lichen Planus: A Randomised Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Source Of Data: The present study will be conducted at the Oral Medicine &Radiology Department of the Goa Dental College & Hospital, Bambolim, Goa. The patients of either sex reporting to the Department with clinical and histopathological diagnosis as a case of Oral Lichen Planus will be included in the prospective clinical trial after obtaining informed consent.
Method of collection of Data including sampling procedure:
**Study design:**Two-arm randomized (1:1), controlled clinical trial. The study will include subjects with clinically and histopathologically diagnosed cases of Oral Lichen Planus, these patients will be equally divided into experimental and control group. The experimental group will receive Photobiomodulation therapy, 10 sessions for 4 weeks where subgroup 1 will receive Photobiomodulation therapy 2 times a week and subgroup 2 will receive Photobiomodulation therapy 3 times a week. Control group will be given 0.1percent triamcinolone acetonide which will be instructed to use thrice daily for 15 minutes over the affected area for 4 weeks.
Sampling method: permuted block method
Sample size: 30
Inclusion Criteria:
Patients were enrolled in the study when they had erosive oral lichen planus diagnosed by clinical examination that complied with WHO modified criteria (2003) for OLP diagnosis.
Patients with biopsy proved Oral Lichen Planus lesions.
Patient above 20 years of age.
Patient willing to participate in the study.
Exclusion Criteria:
Patients currently on corticosteroid therapy or had been on treatment during the past 3 months.
Patients administering anti-inflammatory drugs, illicit drugs, any medications associated with oral lichenoid reactions, or treatment for cancer.
Patients with any uncontrolled systemic diseases, pregnant or breast-feeding women, and smokers.
Presence of amalgam restorations near the OLP lesions.
Pregnant or lactating females.
Patients with associated cutaneous lesions.
Patient not willing to participate.
Materials:
Methods: Detailed history with clinical examination of the patients will be carried out
Following treatment will be given to patient prior to starting of treatment
Oral Prophylaxis regiment including subgingival scaling, polishing, root planning, curettage or other forms of periodontal surgery as required / recommended by the Department of periodontics.
Restorations of silver amalgam which were identified by the patients as having been done and followed by occurrence of Oral Lichen Planus within 6-8 months of filling being done would be replaced with other restorative materials as per indication.
The patient in the study will be randomly classified into experimental and control
group.
Experimental Group will be given photobiomodulation therapy over affected area.
Control Group will be prescribed 0.1 percent Triamcinolone Acetonide to be applied over affected area thrice daily. As per the lesion resolution tapering of oral paste will be
done.
Patient will be evaluated in three follow-up sessions, after 1, 2, 3 months.
Outcome will be assessed by estimating and comparing the clinical size and presentation of the lesion along with VAS scores at baseline and post
treatment.
Clinical Estimation of The Lesion
The lesions size will be measured and the appearance will be evaluated by the
Thongprasom sign score.
Thongprasom sign score
Score 5 = white striae with erosive area & gt;1 cm2
Score 4 = white striae with erosive area & lt;1 cm2
Score 3 = white striae with atrophic area & gt;1 cm2
Score 2 = white striae with atrophic area & lt;1 cm2
Score 1 = no lesions
Patients will also be examined for burning sensation using VAS Scale. Scores ranged
from 0 (no pain) to 10 (extreme pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with erosive oral lichen planus diagnosed by clinical examination that complied with WHO modified criteria (2003) for OLP diagnosis.
- •Patient above 20 years of age.
- •Patient willing to participate in the study.
排除标准
- •Patients currently on corticosteroid therapy or had been on treatment during the past 3 months.
- •Patients administering anti-inflammatory drugs, illicit drugs, any medications associated with oral lichenoid reactions, or treatment for cancer.
- •Patients with any uncontrolled systemic diseases, pregnant or breast-feeding women, and smokers.
- •Presence of amalgam restorations near the OLP lesions.
- •Patients with associated cutaneous lesions.
研究者
Dr Shivangi Vasta
Goa Dental College and Hospital
