Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus
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|ClinicalTrials.gov Identifier: NCT03293368|
Recruitment Status : Unknown
Verified September 2017 by Abdelhameed Hamid Mohammad Hijazi, Cairo University.
Recruitment status was: Not yet recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
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:
- 12 ml of blood will be assembled from the veins of antecubital fossa
- PRP preparation will be done according to Mostafa et al., 2013
- 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa
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.
|Condition or disease||Intervention/treatment||Phase|
|Erosive Oral Lichen Planus||Biological: Platelet rich plasma Drug: Triamcinolone Acetonide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||February 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
Experimental: Platelet rich plasma
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.
Biological: Platelet rich plasma
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.
Other Name: Platelet rich in growth factors
Active Comparator: Croticosteroids
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.
Drug: Triamcinolone Acetonide
0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa
Other Name: Corticosteroids, Steroids
- Pain [ Time Frame: 3 months ]Pain and burning sensation assessed using Numerical rating scale
- Clinical score [ Time Frame: 3 months ]Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992
- Remission time [ Time Frame: 3 months ]Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293368
|Contact: AbdelHameed H. Hijazi, PhDfirstname.lastname@example.org|
|Study Chair:||Soheir Gaafar, Professor||Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University|