Non-Vital Tooth
Conditions
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).
Interventions
DRUGFormocresol
Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)
Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)
Sponsors
Lahore General Hospital
University of Health Sciences Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibacterial effect | 1 week | Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml) |
Countries
Pakistan
Outcome results
None listed