Clinical trial NCT06653608: Clinical Efficacy of Novel Jasminum-based Calcium Hydroxide Medicament
Official title: Clinical Efficacy of Novel Jasminum-based Nano-reinforced Calcium Hydroxide Medicament on Postoperative Pain: a Triple-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Necrotic Pulp
Acute Apical Periodontitis of Pulpal Origin
Keywords: Endodontic
Necrotic pulp
Apical Periodontitis
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2024-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative pain
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
Study officials:
affiliation: Pakistan Institute of Medical Sciences
name: Nehal Amir, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.