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

Primary Purpose

Non-Vital Tooth

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Formocresol
Allium Sativum Oil
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Vital Tooth

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • de' Montmorency College of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Formocresol (Control-Gold standard-Group A)

Allium sativum oil (Experimental-Group B)

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
March 24, 2023
Sponsor
University of Health Sciences Lahore
Collaborators
Lahore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05801367
Brief Title
Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth
Official Title
Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth- A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Health Sciences Lahore
Collaborators
Lahore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 (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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Vital Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking 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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formocresol (Control-Gold standard-Group A)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Allium sativum oil (Experimental-Group B)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Formocresol
Other Intervention Name(s)
medicament for Non-vital pulpotomy procedure
Intervention Description
Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)
Intervention Type
Drug
Intervention Name(s)
Allium Sativum Oil
Other Intervention Name(s)
medicament for Non-vital pulpotomy procedure
Intervention Description
Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)
Primary Outcome Measure Information:
Title
Antibacterial effect
Description
Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: History of allergy to anesthetics and latex. Radiographic evidence of pulpal floor opening into the furcation area. More than half of the roots resorbed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shazia Naz, BDS, MDS
Organizational Affiliation
Assistant professor operative dentistry de, Montmorency College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
de' Montmorency College of dentistry
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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