Evaluation of Partial Versus Complete Pulpotomy in Carious Immature Young Permanent Teeth Using Bioceramic Material

Partial Versus Complete Pulpotomy in Young Permanent Using Bioceramic Material

One of our major concerns and daily challenges is the management of carious immature permanent teeth, also known as young permanent teeth while preserving the vitality of the dental. Preserving radicular pulp tissue in these teeth allows continuing apical maturation and apical closure.

Diagnosis and treatment of carious immature permanent molars are considered a challenging aspect of daily clinical routine, where constant irritation of the pulp without treatment leads to irreversible pulpitis and necrosis, which impedes the natural root development and its complete formation ; leading at the end to a decision of extracting the tooth .Therefore; when treating immature permanent teeth, the main goal is to preserve the vitality of the pulp to guarantee natural root development.

Pulpotomy is a commonly employed treatment for this procedure involving either the removal of only the outer layer of damaged and hyperemic tissue in exposed pulps (partial pulpotomy or Cvek pulpotomy); which is a procedure staged between pulp capping and complete pulpotomy.

Complete pulpotomy is the total removal of coronal pulp tissue and the placement of a wound dressing on the canal orifice. Followed by the placement of a biocompatible material to promote healing and regeneration of the remaining vital pulp tissue.

In many studies, MTA showed high success rates in treatment of carious immature permanent molars. However, MTA is expensive and has poor handling characteristics, a long setting time and no predictable antimicrobial activity.

Recently, new bioceramics have emerged as promising materials, showing good potential for vital pulp therapy in immature permanent teeth due to their biocompatibility and favorable clinical outcomes.

Both MTA and bioceramics have almost similar compositions, but bioceramics materials contain titanium oxide and calcium phosphate, in addition to the absence of aluminum in its composition. Besides, bioceramics can release a high percentage of calcium ions early while maintaining this high percentage for 28 days, in contrast to the mineral trioxide, which showed a lower ability to release calcium ions more slowly.

Therefore, this study will be conducted to compare the effectiveness bioceramic material in partial and complete pulpotomy of immature permanent molars.

Study Overview

• Status: Not yet recruiting
• Conditions: Carious Teeth
• Intervention / Treatment: Procedure: partial pulpotomy; Procedure: Complete pulpotomy

Detailed Description

comparing the effectiveness of bioceramic material in partial and complete pulpotomy in carious immature permanent molars.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Ahmed Abdel Azim, Assistant lecturer; Phone Number: 01001888133; Email: heba.abdelazim@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Children with vital immature mandibular first permanent molars; with clinical carious exposure of the pulp and presence of bleeding upon exposure.
2. Age ranges from 6-10 years.
3. No history of spontaneous pain.
4. Absence of sinus tract, sinus swelling.
5. The posterior teeth could be restored.

Exclusion Criteria:

1-History of spontaneous pain, or pain that wakes up the child at night. 2-Teeth with closed apex. 3-Teeth with furcation, prominent radiolucency in the periapical region. 4-Teeth with excessive mobility. 5-Non-restorable molars.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: partial pulpotomy in immature permanent teeth; partial removal of coronal pulp tissue	Procedure: partial pulpotomy; Partial removal of pulp tissue in young permanent teeth
Active Comparator: complete pulpotomy in immature permanent teeth; complete removal of pulp in pulp chamber	Procedure: Complete pulpotomy; Complete removal of pulp tissue in young permanent teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	patient will be asked if there is pain or no	3 months,6 months, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic evaluation	the radiograph will be evaluated for thickening of dentine walls, root completion.	3 months,6 months, 1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 14422023560059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No