Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth

NCT05801367 | Completed Phase 1

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

Brief Summary

The purpose of this randomized controlled clinical trial is to use Allium sativum oil 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 Allium sativum oil 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) will be used in this research. Composition was Tricresol 35%, Formaldehyde (40%) 19%, excipient additive 100% (PD, Switzerland, ISO9001/ISO9001\_2000/ ISO13485/CE\_MARK), (Universal Dental Pvt, Ltd)

Drug: Formocresol

Allium sativum oil (Experimental-Group B)

EXPERIMENTAL

Premade Allium sativum oil (Garlic oil) (Mohammad and Baroudi, 2015b) will be used in this research (SAC group of companies-9001:2015 certified; Registration # PAK17.1724-U; NTN # 0299739-8, Karachi, Pakistan

Drug: Allium Sativum Oil

Interventions

Formocresol DRUG

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

Also known as: medicament for Non-vital pulpotomy procedure

Formocresol (Control-Gold standard-Group A)

Allium Sativum Oil DRUG

Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)

Also known as: medicament for Non-vital pulpotomy procedure

Allium sativum oil (Experimental-Group B)

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; allyl sulfide

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Shazia Naz, BDS, MDS

  Assistant professor operative dentistry de, Montmorency College of Dentistry

  PRINCIPAL INVESTIGATOR

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)

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)