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

Non-Vital Tooth Clinical Trial

Official title:

Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth- A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05801367
• Other study ID #: UniversityUHS
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 20, 2022
• Est. completion date: March 2, 2023

Study information

• Verified date: March 2023
• Source: University of Health Sciences Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 (Allium sativum oil). 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

1. Cooperation of patients and consent of parents.

2. Patients with ASA classification I and II (mild to moderate systemic disease).

3. Non-traumatic extensively carious hence restorable primary molars.

4. No history of antibiotic use for 2 weeks.

5. 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.

Exclusion Criteria:

1. History of allergy to anesthetics and latex.

2. Radiographic evidence of pulpal floor opening into the furcation area.

3. More than half of the roots resorbed.

Related Conditions & MeSH terms

• Non-Vital Tooth
• Tooth, Nonvital

Intervention

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

Locations

Country	Name	City	State
Pakistan	de' Montmorency College of dentistry	Lahore	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
University of Health Sciences Lahore	Lahore General Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibacterial effect	Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)	1 week