Turmeric Gel as Alternative Non-vital Pulpotomy Medicament in Primary Teeth

NCT05801354 | Completed Phase 1

• 1 other identifier: UHSUniversity
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Vital Tooth

Outcome Measures

Primary Outcomes (1)

• Antibacterial effect

  Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)

  1 week

Study Arms (2)

Formocresol (Control-Gold standard-Group A)

ACTIVE COMPARATOR

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 (Experimental-Group B)

EXPERIMENTAL

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

Interventions

Turmeric Gel DRUG

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

Turmeric gel (Experimental-Group B)

Formocresol DRUG

Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)

Also known as: Medicaments for non-vital pulpotomy procedure

Formocresol (Control-Gold standard-Group A)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cooperation of patients and consent of parents.
• Patients with ASA classification I and II (mild to moderate systemic disease).
• Non-traumatic extensively carious hence restorable primary molars.
• No history of antibiotic use for 2 weeks.
• Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/ redness/ swelling, and/or slight mobility-grade I.

You may not qualify if:

• History of allergy to anesthetics and latex.
• Radiographic evidence of pulpal floor opening into the furcation area.
• More than half of the roots resorbed.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead
• Lahore General Hospital: collaborator

Study Sites (1)

de' Montmorency College of Dentistry

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

formocresol

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Shazia Naz, BDS, MDS

  Associate Professor of Operative Dentistry (Supervisor)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and assessors involved in the study from randomization, allocation, bacteriological outcome, and data analysis will be blinded to which medicament group the patients belonged as all data will be coded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental Surgeon (Ex-Postgraduate trainee)

Model Details: Turmeric gel= interventional drug Formocresol= Control drug (standard drug)

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 6, 2023
• Study Start: October 20, 2022
• Primary Completion: February 23, 2023
• Study Completion: March 2, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)