Acute Apical Periodontitis of Pulpal Origin, Necrotic Pulp
Conditions
Keywords
Endodontic, Necrotic pulp, Apical Periodontitis
Brief summary
A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced calcium hydroxide medicament was utilized while in group B, calcium hydroxide medicament without nanoparticles was used. Post-operative pain was assessed after 4 hours, 24 hours, 48 hours, 72 hours, 96 hours.
Detailed description
This triple-blind parallel group, randomized clinical trial was conducted at the department of Operative Dentistry and Endodontics, School of Dentistry from April 24, 2024 to September 25, 2024. Participants were randomly distributed into two groups by Lottery method. A consecutive non-probability sampling technique was used. Before initiating treatment, participants were briefed about the intervention and their preoperative pain score was recorded. In both groups, endodontic treatment was initiated under rubber dam isolation. Access opening done and canals explored. Working length taken by radiographic method and reconfirmed by an electronic apex locator. Afterwards, canals were prepared till Master Apical File size F2 (4% Taper). In group A, Nano-reinforced calcium hydroxide medicament was placed while in group B, calcium hydroxide without nanoparticles was utilized. Participants were instructed to rate their postoperative pain record after 4hrs, 24hrs, 48hrs, 72hrs and 96hrs.
Interventions
DRUGNano-reinforced calcium hydroxide medicament
Group A (Calcium hydroxide intracanal medicament reinforced with jasminum derived- titania nanoparticles)
DRUGCalcium hydroxide without nanoparicles
Group B ( Calcium hydroxide medicament without nanoparticles)
Sponsors
Pakistan Institute of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
In this triple-blind trial, participants, care provider and outcome assessor were unaware of the study groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants with good general health status * Necrotic pulp with Symptomatic Apical Periodontitis * Single rooted teeth
Exclusion criteria
* Non-restorable teeth * Teeth associated with acute or chronic apical abscess * Teeth with chronic periodontitis * Teeth with anatomical complexities or complications like open apex, calcified canal, severe root dilaceration, root resorptive defects * Participants who received antibiotic treatment during the last 3 months * Pregnant females * Participants on pre-treatment analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | One week | Pain scores assessed by Visual Analogue Scale (VAS) score after 4hr, 24hrs, 48hrs, 72hrs, 96hrs. The minimum score is O (None) and the maximum score is 10 (Severe). |
Countries
Pakistan
Outcome results
None listed