Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament

Not Applicable

Completed

• Conditions: Necrotic Pulp; Acute Apical Periodontitis of Pulpal Origin
• Interventions: Drug: Nano-reinforced calcium hydroxide medicament; Drug: Calcium hydroxide without nanoparicles

• Registration Number: NCT06653608
• Lead Sponsor: Pakistan Institute of Medical Sciences

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.

Study Timeline

• Study Start: 2024-04-24
• Primary Completion: 2024-09-25
• Study Completion: 2024-09-25
• Status Verified: 2024-10
• Study First Submitted: 2024-10-19
• Study First Submitted QC: 2024-10-19
• Study First Posted: 2024-10-22
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Nano-reinforced Calcium hydroxide)	Nano-reinforced calcium hydroxide medicament	Nano-reinforced Calcium hydroxide Medicament
Group B (Conventional Calcium hydroxide)	Calcium hydroxide without nanoparicles	Calcium hydroxide without nanoparticles

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University; 🇵🇰 Islamabad, Pakistan