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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03320460
Other study ID # 2.375.410
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date December 2020

Study information

Verified date December 2018
Source University of Nove de Julho
Contact Ana Paula C Silva, Bachelor
Phone + 55 11 3385-9197
Email aninha@uninove.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% for 30 consecutive days and with placebo PBM twice a week. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy 177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable (pain) and the secondary variables including clinical scores and functional scores as well as patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p < 0.05).


Description:

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Study Design


Intervention

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Locations

Country Name City State
Brazil Scholl of Dentistry, University of São Paulo São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Pain of OLP The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation. Participants will be evaluated at baseline (Day 0)
Primary Assessment of Pain of OLP The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation. Participants will be evaluated after 1 week of treatment (Day 7)
Primary Assessment of Pain of OLP The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation. Participants will be evaluated after 2 weeks of treatment (Day 14)
Primary Assessment of Pain of OLP The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation. Participants will be evaluated after 3 weeks of treatment (Day 21)
Primary Assessment of Pain of OLP The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation. Participants will be evaluated after 4 weeks of treatment (Day 30)
Primary Assessment of Pain of OLP The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation. 30 days after the discontinuation of treatment (follow-up period)
Primary Assessment of Pain of OLP The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation. 60 days after the discontinuation of treatment (follow-up period)
Secondary Assessment of clinical presentation of OLP Clinical data will be evaluated by scores according to Thongprasom et al Participants will be evaluated at baseline (Day 0)
Secondary Assessment of clinical presentation of OLP Clinical data will be evaluated by scores according to Thongprasom et al Participants will be evaluated after 1 week of treatment (Day 7)
Secondary Assessment of clinical presentation of OLP Clinical data will be evaluated by scores according to Thongprasom et al Participants will be evaluated after 2 weeks of treatment (Day 14)
Secondary Assessment of clinical presentation of OLP Clinical data will be evaluated scores according to Thongprasom et al Participants will be evaluated after 3 weeks of treatment (Day 21)
Secondary Assessment of clinical presentation of OLP Clinical data will be evaluated by scores according to Thongprasom et al Participants will be evaluated after 4 weeks of treatment (Day 30)
Secondary Assessment of clinical presentation of OLP Clinical data will be evaluated by scores according to Thongprasom et al 30 days after the discontinuation of treatment (follow-up period)
Secondary Assessment of clinical presentation of OLP Clinical data will be evaluated by scores according to Thongprasom et al 60 days after the discontinuation of treatment (follow-up period)
Secondary Function The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function). Participants will be evaluated at baseline (Day 0)
Secondary Function The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function). Participants will be evaluated after 1 week of treatment (Day 7)
Secondary Function The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function). Participants will be evaluated after 2 weeks of treatment (Day 14)
Secondary Function The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function). Participants will be evaluated after 3 weeks of treatment (Day 21)
Secondary Function The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function). Participants will be evaluated after 4 weeks of treatment (Day 30)
Secondary Function The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function). 30 days after the discontinuation of treatment (follow-up period)
Secondary Function The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function). 60 days after the discontinuation of treatment (follow-up period)
Secondary Clinical Resolution The clinical resolution will be evaluated at the end of treatment (day 30) according to Corozzo et al. (1999). Complete resolution will be considered when patients present absence of symptoms and remission of atrophic/erosive lesions regardless the presence of any persisting hyperkeratotic lesions. Partial resolution will be considered when a decrease but not the complete remission of atrophic/erosive areas and symptoms were observed. No response to treatment will be considered when OLP lesions present the same clinical or worse presentation in relation to the baseline condition. Participants will be evaluated after 4 weeks of treatment (Day 30)
Secondary Recurrence rate No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period. The recurrence rate will be evaluated 30 days after the discontinuation of treatment (follow-up period)
Secondary Recurrence rate No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period. The recurrence rate will be evaluated 60 days after the discontinuation of treatment (follow-up period)
Secondary Salivary levels of IL-1ß, IL-6, IL-8, IL-10 and TNFa The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1ß, INF-? and TNF-a will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions. Baseline (day 0)
Secondary Salivary levels of IL-1ß, IL-6, IL-8, IL-10 and TNFa The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1ß, INF-? and TNF-a will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions. After 4 weeks of treatment (Day 30)
Secondary Serum levels of IL-1ß, IL-6, IL-8, IL-10 and TNFa Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1ß, INF-? and TNF-a will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions. Baseline (Day 0)
Secondary Serum levels of IL-1ß, IL-6, IL-8, IL-10 and TNFa Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1ß, INF-? and TNF-a will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions. After 4 weeks of treatment (Day 30)
Secondary Assessment of Quality of life in OLP patients Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14) Baseline (Day 0)
Secondary Assessment of Quality of life in OLP patients Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14) After 4 weeks of treatment (Day 30)
Secondary Assessment of Quality of life in OLP patients Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14) 30 days after the discontinuation of treatment (follow-up period)
Secondary Assessment of Quality of lifein OLP patients Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14) 60 days after the discontinuation of treatment (follow-up period)
Secondary Anxiety and Depression Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS) Baseline (Day 0)
Secondary Anxiety and Depression Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS) Participants will be evaluated after 1 week of treatment (Day 7)
Secondary Anxiety and Depression Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS) Participants will be evaluated after 2 weeks of treatment (Day 14)
Secondary Anxiety and Depression Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS) Participants will be evaluated after 3 weeks of treatment (Day 21)
Secondary Anxiety and Depression Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS) Participants will be evaluated after 4 weeks of treatment (Day 30)
Secondary Anxiety and Depression Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS) 30 days after the discontinuation of treatment (follow-up period)
Secondary Anxiety and Depression Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS) 60 days after the discontinuation of treatment (follow-up period)
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