A Phase 1/2 interventional study of Turmeric Gel and Formocresol in Non-Vital Tooth, sponsored by University of Health Sciences Lahore. Completed at 1 site in Pakistan. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by University of Health Sciences Lahore · Phase 1/2, Interventional, and Treatment
The purpose of this randomized controlled clinical trial is to use Turmeric gel as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Turmeric gel compared with Formocresol, when used as non-vital Pulpotomy medicaments.
It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Turmeric gel). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).
113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.
Browse Tooth, Nonvital studies →University of Health Sciences Lahore is the lead sponsor of 77 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
Premade Formocresol (Tricresol \& Formalin) was used composed of Tricresol 35%, Formaldehyde (40%) 19%, excipient additive 100% (PD, Switzerland, ISO9001/ISO9001_2000/ ISO13485/CE_MARK), (Universal Dental Pvt, Ltd).
Drug: Formocresol
Turmeric gel will be self-prepared at the Institute of Microbiology and Molecular Genetics, Punjab University, Lahore. 2kgs of Turmeric rhizomes were purchased from a local market in Lahore and verified by a taxonomist, Botany Department, Government College University, Lahore (voucher number: GC.Herb.Bot.3693). Approximately 170g powder along with 550ml distilled water will be taken in a Soxhlet extractor for 96 hours and then filtered repeatedly through Whatman No.1 filter paper. The obtained filtrate will then be mixed with 6% Sodium Carboxy-Methyl Cellulose (NaCMC) (Genevex Chem, Hyderabad, India) to form gel. Four Vitamin C grounded tablets (Wilson's Vitamin C, Wilson's Healthcare, Islamabad, Pakistan) and twelve Vitamin E capsules (Evion, Martin Dow pharmaceuticals, Ltd. Karachi, Pak) will then be added in 100g of gel as antioxidants.
Drug: Turmeric Gel
Turmeric gel will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)
Also known as: Medicaments for non-vital pulpotomy procedure
Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)
Also known as: Medicaments for non-vital pulpotomy procedure
Antibacterial effect
Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)
Time frame: 1 week
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Lahore