NCT06653608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 19, 2024

Last Update Submit

October 27, 2024

Conditions

Necrotic PulpAcute Apical Periodontitis of Pulpal Origin

Keywords

EndodonticNecrotic pulpApical Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    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

Study Arms (2)

Group A (Nano-reinforced Calcium hydroxide)

EXPERIMENTAL

Nano-reinforced Calcium hydroxide Medicament

Drug: Nano-reinforced calcium hydroxide medicament

Group B (Conventional Calcium hydroxide)

EXPERIMENTAL

Calcium hydroxide without nanoparticles

Drug: Calcium hydroxide without nanoparicles

Interventions

Nano-reinforced calcium hydroxide medicamentDRUG

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

Also known as: Group A
Group A (Nano-reinforced Calcium hydroxide)
Calcium hydroxide without nanopariclesDRUG

Group B ( Calcium hydroxide medicament without nanoparticles)

Also known as: Group B
Group B (Conventional Calcium hydroxide)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with good general health status
  • Necrotic pulp with Symptomatic Apical Periodontitis
  • Single rooted teeth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

Location

Related Publications (3)

  • Khan AM, Gangoo IKA, Ali NA, Khan M, Javed MQ, AlAttas MH, Abulhamael AM, Bahammam HA, Alsofi L, Yahya RSA. The Effect of Calcium Hydroxide, Triple Antibiotic Paste and Chlorhexidine on Pain in Teeth with Symptomatic Apical Periodontitis: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Feb 10;20(4):3091. doi: 10.3390/ijerph20043091.

    PMID: 36833788BACKGROUND

  • Ghanbarzadegan A, Ajami M, Aminsobhani M. The Effect of Different Combinations of Calcium Hydroxide as Intra-Canal Medicament on Endodontic Pain: A Randomized Clinical Trial Study. Iran Endod J. 2019 Winter;14(1):1-6. doi: 10.22037/iej.v14i1.22815.

    PMID: 36879602BACKGROUND

  • Amir N, Mansoor E, Eeman N, Ahmed MN, Mansoor E, Mansoor E, Hussain K, Afreixo V, Mansoor A, Brochado Martins JF, Palma PJ. Jasminum-based Nano-reinforced Calcium Hydroxide Reduces Postoperative Pain in Symptomatic Apical Periodontitis: A Randomized Controlled Trial. J Endod. 2025 Aug;51(8):996-1005. doi: 10.1016/j.joen.2025.05.016. Epub 2025 Jun 2.

    PMID: 40466913DERIVED

MeSH Terms

Conditions

Dental Pulp NecrosisPeriapical Periodontitis

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsPeriapical DiseasesJaw DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Officials

  • Nehal Amir, BDS

    Pakistan Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
In this triple-blind trial, participants, care provider and outcome assessor were unaware of the study groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2024

First Posted

October 22, 2024

Study Start

April 24, 2024

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)