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

Carious Teeth Clinical Trial

Official title:

Partial Versus Complete Pulpotomy in Young Permanent Using Bioceramic Material

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06101550
• Other study ID #: 14422023560059
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: Heba Ahmed Abdel Azim, Assistant lecturer
• Phone: 01001888133
• Email: heba.abdelazim[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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.

-

Related Conditions & MeSH terms

• Carious Teeth
• Dental Caries

Intervention

Procedure:
• partial pulpotomy
Partial removal of pulp tissue in young permanent teeth
• Complete pulpotomy
Complete removal of pulp tissue in young permanent teeth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post operative pain	patient will be asked if there is pain or no	3 months,6 months, 1 year
Secondary	radiographic evaluation	the radiograph will be evaluated for thickening of dentine walls, root completion.	3 months,6 months, 1 year