NCT06653608

Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament

Clinical Efficacy of Novel Jasminum-based Nano-reinforced Calcium Hydroxide Medicament on Postoperative Pain: a Triple-blind Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pakistan Institute of Medical Sciences · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Necrotic Pulp
• Acute Apical Periodontitis of Pulpal Origin

Interventions

Type	Name	Description
DRUG	Nano-reinforced calcium hydroxide medicament	Group A (Calcium hydroxide intracanal medicament reinforced with jasminum derived- titania nanoparticles)
DRUG	Calcium hydroxide without nanoparicles	Group B ( Calcium hydroxide medicament without nanoparticles)

Timeline

• Start date: 2024-04-24
• Primary completion: 2024-09-25
• Completion: 2024-09-25
• First posted: 2024-10-22
• Last updated: 2024-10-30

Locations

1 site across 1 country: Pakistan