Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament

October 27, 2024 updated by: NEHAL AMIR, Pakistan Institute of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan
        • School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Nano-reinforced Calcium hydroxide)
Nano-reinforced Calcium hydroxide Medicament
Drug: Nano-reinforced calcium hydroxide medicament
Group A (Calcium hydroxide intracanal medicament reinforced with jasminum derived- titania nanoparticles)
Other Names:
  • Group A
Experimental: Group B (Conventional Calcium hydroxide)
Calcium hydroxide without nanoparticles
Drug: Calcium hydroxide without nanoparicles
Group B ( Calcium hydroxide medicament without nanoparticles)
Other Names:
  • Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: 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).
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Medical Sciences

Investigators

  • Principal Investigator: Nehal Amir, BDS, Pakistan Institute of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

September 25, 2024

Study Completion (Actual)

September 25, 2024

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 19, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 27, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOD/ERB/2024/58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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