Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-24

Study Completion Date

2024-09-25

Brief Summary

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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.

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Detailed Description

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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

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Necrotic Pulp Acute Apical Periodontitis of Pulpal Origin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

In this triple-blind trial, participants, care provider and outcome assessor were unaware of the study groups.

Study Groups

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Group A (Nano-reinforced Calcium hydroxide)

Nano-reinforced Calcium hydroxide Medicament

Group Type EXPERIMENTAL

Nano-reinforced calcium hydroxide medicament

Intervention Type DRUG

Group A (Calcium hydroxide intracanal medicament reinforced with jasminum derived- titania nanoparticles)

Group B (Conventional Calcium hydroxide)

Calcium hydroxide without nanoparticles

Group Type EXPERIMENTAL

Calcium hydroxide without nanoparicles

Intervention Type DRUG

Group B ( Calcium hydroxide medicament without nanoparticles)

Interventions

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Nano-reinforced calcium hydroxide medicament

Group A (Calcium hydroxide intracanal medicament reinforced with jasminum derived- titania nanoparticles)

Intervention Type DRUG

Calcium hydroxide without nanoparicles

Group B ( Calcium hydroxide medicament without nanoparticles)

Intervention Type DRUG

Other Intervention Names

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Group A Group B

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes