Clinical trial NCT05819970: Allium Sativum Oil and Turmeric Gel as Alternative Non-vital Pulpotomy Medicaments in Primary Teeth.
Official title: Allium Sativum Oil and Turmeric Gel as Alternative Non-vital Pulpotomy Medicaments in Primary Teeth- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non Vital Teeth
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
Collaborators: name: Lahore General Hospital
First posted: 2023-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to use Allium sativum oil and Turmeric gel as non-vital Pulpotomy medicaments in primary teeth by evaluating their antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus.

It is hypothesized that there is no difference in the antibacterial effect of Allium sativum oil and Turmeric gel when used as non-vital Pulpotomy medicaments.

Detailed 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 (Allium sativum oil) 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).

Eligibility criteria: 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 nonvital 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.

Primary outcomes:
measure: Antibacterial effect
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: de' Montmorency College of Dentistry
state: Punjab
Study officials:
affiliation: Associate Professor of Operative Dentistry (Supervisor)
name: Shazia Naz, BDS, MDS
role: STUDY_DIRECTOR
References: