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After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant in the intervention group will receive intralesional injections of platelet rich plasma extracted from their own blood in each visit as following:
The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of ulcerated mucosa
Both groups will receive a total of 4 injection, the injections will be carried out once a week.
Pain, lesions size and remission time are the outcomes will be assessed using a numerical rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary scale for remission time according to Conrotto et al., 2006, respectively.
Assessment of the outcomes will be carried before the trial (baseline records) and before receiving the treatment in each visit by the primary investigator (H.A.) and the blinded assessor (Dr. A.W.) separately.
Each participant will have a total of 11 visits during the trial, 5 visits will be once every week during the trial and every 2 weeks for 3 months treatment free.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich plasma | Experimental | 0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus. |
|
| Croticosteroids | Active Comparator | 0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma | Biological | Platelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa. |
| Measure | Description | Time Frame |
|---|---|---|
| Reported Pain | Pain and burning sensation assessed using Numerical rating scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical score | Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992 | 3 months |
| Remission time | Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soheir Gaafar, Professor | Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35218680 | Derived | Hijazi A, Ahmed W, Gaafar S. Efficacy of intralesional injections of platelet-rich plasma in patients with oral lichen planus: A pilot randomized clinical trial. Clin Exp Dent Res. 2022 Jun;8(3):707-714. doi: 10.1002/cre2.550. Epub 2022 Feb 26. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 | Sep 21, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| D014222 | Triamcinolone Acetonide |
| D000305 | Adrenal Cortex Hormones |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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|
| Triamcinolone Acetonide | Drug | 0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa |
|
|
| 3 months |
| D014221 |
| Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |