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Completed

NCT Number: NCT06653608

Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament

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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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nano-reinforced calcium hydroxide medicament

Drug

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

Other names: Group A

Calcium hydroxide without nanoparicles

Drug

Group B ( Calcium hydroxide medicament without nanoparticles)

Other names: Group B

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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