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

NCT06101550 | Not Yet Recruiting

• 1 other identifier: 14422023560059
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carious Teeth

Outcome Measures

Primary Outcomes (1)

• post operative pain

  patient will be asked if there is pain or no

  3 months,6 months, 1 year

Secondary Outcomes (1)

• radiographic evaluation

  3 months,6 months, 1 year

Study Arms (2)

partial pulpotomy in immature permanent teeth

EXPERIMENTAL

partial removal of coronal pulp tissue

Procedure: partial pulpotomy

complete pulpotomy in immature permanent teeth

ACTIVE COMPARATOR

complete removal of pulp in pulp chamber

Procedure: Complete pulpotomy

Interventions

partial pulpotomy PROCEDURE

Partial removal of pulp tissue in young permanent teeth

partial pulpotomy in immature permanent teeth

Complete pulpotomy PROCEDURE

Complete removal of pulp tissue in young permanent teeth

complete pulpotomy in immature permanent teeth

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Heba Ahmed Abdel Azim, Assistant lecturer

CONTACT

01001888133; heba.abdelazim@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 26, 2023
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07