Clinical and Radiographic Outcomes of Partial Pulpotomy Procedure in Primary Molars Utilizing Different Capping Materials and Different Restorative Methods

  • STATUS
    Recruiting
  • End date
    Dec 29, 2025
  • participants needed
    84
  • sponsor
    British University In Egypt
Updated on 29 January 2024
Accepts healthy volunteers

Summary

the goal of this clinical trial is to compare clinical and radiographic outcomes of partial pulpotomy in vital primary molars using TheraCal PT®, Biodentin® and NeoPUTTY® MTA , followed by glass ionomer restoration only or glass ionomer restoration and stainless-steel crown.

Description

  • Primary teeth act as natural space maintainers for the subsequent dentition, they also aid in mastication, satisfactory esthetics and proper articulation of letters. So, it is of prime importance to maintain and preserve their vitality and function through vital pulp therapy (VPT). Ideal VPT materials would sustain pulp vitality, encourage pulp healing. Due to their biocompatibility, bioactivity, and superior sealing capacity, tricalcium silicates (TCSs), such as mineral trioxide aggregate (MTA) and Biodentine®, are currently the most widely used materials for VPT in permanent and primary teeth.Other calcium silicate-based compounds, such as TheraCal PT®, have recently been introduced to the market. TheraCal PT®, a dual-cured variation of its light-cured predecessor Theracal LC®, has improved its chemical capabilities to mitigate the potential harmful consequences of leaving un polymerized monomers.
    • The best course of action for primary molars with deep carious lesions that aren't exhibiting any symptoms or indicators of irreversible pulpitis has posed challenges for years. With pulp capping and pulpotomy available as options for primary teeth, and partial pulpotomy in young permanent teeth according to the American Academy of Pediatric Dentistry (AAPD) guidelines for vital pulp therapy. A less invasive version of pulpotomy which is partial pulpotomy uses more conservative theories and biologic principles to produce better clinical results
    • New iterations of calcium silicate-based materials have been created for usage as vital pulp therapy material due to their advantageous biological, physical, and mechanical qualities. Additionally, they promote growth factor production and differentiation into odontoblast like cells .
    • TheraCal PT® advantages include that it has a hydrophilic matrix which releases Calcium ions. Koutroulis et al.,stated that the increased antibacterial efficacy and calcium release are strongly linked. Also, Calcium release has been linked to the biological characteristics of hydraulic cements because it promotes the differentiation potential of dental pulp cells and enhances mineralization, which results in deposition of a dentine-like barrier on the pulp's surface on the long-term. The other advantage that it increases the pH which provides anti-bacterial activity.
    • there is lack of evidence in partial pulpotomy in treatment of carious primary teeth, the materials that could be used in it and necessity of using crown after it.
    • this clinical trial will be performed to provide evidence based answer for treatment of primary molars using partial pulpotomy the materials that could be used in it and necessity of using crown after it.

-• Children will be allocated into either one of the groups of partial pulpotomy depending on the medicament used as follows:

  • Group 1A: (control group) MTA and stainless-steel crown.
  • Group 1B: MTA and glass ionomer restoration.
  • Group 2A: Biodentin® and stainless-steel crown.
  • Group 2B: Biodentin® and glass ionomer restoration.
  • Group 3A: TheraCal PT® and stainless-steel crown.
  • Group 3B: TheraCal PT® and glass ionomer restoration. All of the medicaments will be applied according to the manufacturer's instructions and gently placed over the pulp tissue to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement
  • Clinical follow up after 3,6,9 and12 months while radiographic follow up every 6 months.
  • Parents will be asked if any complains occurred between follow up visits by phone

Details
Condition Pulp Disease, Dental
Age 4years - 7years
Treatment partial pulpotomy
Clinical Study IdentifierNCT06227390
SponsorBritish University In Egypt
Last Modified on29 January 2024

Eligibility

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.