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

NCT ID: NCT06227390

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2025-08-31

Brief 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.

Detailed 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

Conditions

Pulp Disease, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MTA and stainless-steel crown

Group Type: EXPERIMENTAL

partial pulpotomy

Intervention Type: PROCEDURE

2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair

Biodentine® and stainless-steel crown

Group Type: EXPERIMENTAL

partial pulpotomy

Intervention Type: PROCEDURE

2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair

TheraCal PT® and stainless-steel crown

Group Type: EXPERIMENTAL

partial pulpotomy

Intervention Type: PROCEDURE

2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair

MTA and glass ionomer restoration

Group Type: EXPERIMENTAL

partial pulpotomy

Intervention Type: PROCEDURE

2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair

Biodentine® and glass ionomer restoration

Group Type: EXPERIMENTAL

partial pulpotomy

Intervention Type: PROCEDURE

2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair

TheraCal PT® and glass ionomer

Group Type: EXPERIMENTAL

partial pulpotomy

Intervention Type: PROCEDURE

2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair

Interventions

partial pulpotomy

2-3 mm of the coronal pulp tissue is removed leaving healthy vital pulp tissue that is dressed with a dental biomaterial that maintains pulpal vitality and promotes repair

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Healthy patients aged 4-7-years old.

2. Cooperative patients (Frankle scale + and ++)

3. Asymptomatic primary molar with deep caries requiring vital pulp therapy

Exclusion Criteria

• presence of any of the following:

1. History of spontaneous lingering pain, swelling, or sinus tract.

2. Pathological mobility.

3. pain on percussion.

4. Furcation or periapical radiolucency.

5. pathological root resorption

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Ali Elsharkawy

demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the British University in Egypt

Cairo, , Egypt

Countries

Egypt

Other Identifiers

23-005

Identifier Type: -

Identifier Source: org_study_id