Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament

Pakistan Institute of Medical Sciences

Status: Completed

Conditions: Necrotic Pulp; Acute Apical Periodontitis of Pulpal Origin

Treatments: Drug: Calcium hydroxide without nanoparicles; Drug: Nano-reinforced calcium hydroxide medicament

Study type: Interventional

Funder types: Other

Identifiers

NCT06653608

SOD/ERB/2024/58

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group A (Nano-reinforced Calcium hydroxide)

Experimental group

Description:

Nano-reinforced Calcium hydroxide Medicament

Treatment:

Drug: Nano-reinforced calcium hydroxide medicament

Group B (Conventional Calcium hydroxide)

Experimental group

Description:

Calcium hydroxide without nanoparticles

Treatment:

Drug: Calcium hydroxide without nanoparicles