Three Dimensional Evaluation of Apexogenesis of Immature Young Permanent Teeth With Different Endodontic Material

Not Applicable

Recruiting

• Conditions: Deep Carious Young 1st Permanent Molar With Open Apex
• Interventions: Procedure: endo-sequence putty; Procedure: neo-MTA putty

• Registration Number: NCT05790629
• Lead Sponsor: Al-Azhar University

Brief Summary

Randomized Clinical Trial using Three Dimensional Evaluation of Apexogensis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties

Detailed Description

Treatment of immature permanent teeth has always been challenging in endodontics, not only because of their wide-open root apices but also because of the thin underdeveloped dentinal walls.Apexogenesis falls under the category of vital pulp therapy (VPT) procedure to maintain pulp vitality, induce dentin bridge formation and encourage continued root maturation.

To overcome the drawbacks of tricalcium silicate-based cements, a range of bioactive endodontic cements have been developed.

EndoSequence BC RRM-Fast Set Putty and NeoPutty (NuSmile, Houston, TX, USA) are the two materials evaluated in this study.

Study Timeline

• Study Start: 2022-08-08
• Study First Submitted: 2023-02-01
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-17
• Last Update Submitted: 2023-03-17
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30
• Primary Completion: 2024-04
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• First permanent molar with pulpitis.
• Sufficient tooth structure for placing rubber dam.
• Presence of open apex.
• Short root length.

Exclusion Criteria

• Insufficient tooth structure that need post and core.
• Presence of swelling.
• Presence of sinus tract.
• Presence of root fracture.
• Presence of root crack.
• Presence of external or internal root resorption.
• Presence of periapical pathosis.
• Presence of root calcification.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (I) control	endo-sequence putty	young permanent pulpy exposed carious tooth of the selected participants will be treated with specific technique called apexogenesis using bio-compatible material (endo-sequence putty ). This material is administrated to the tooth by placing about 2-4 mm bulk of material in the pulp champers at the cervical line then sealing the capping material with glass ionomer and stainless steel crown.
Group (II)	neo-MTA putty	young permanent pulpy exposed carious tooth of the selected participants will be treated with specific technique called apexogenesis using bio-compatible material (neo-MTA putty). This material is administrated to the tooth by placing about 2-4 mm bulk of material in the pulp champers at the cervical line then sealing the capping material with glass ionomer and stainless steel crown.

Primary Outcome Measures

Name	Time	Method
asymptomatic	one year	pain relief after procedure by Numeric rating scales on follow up visits.Most pain scales use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain you have ever felt.

Secondary Outcome Measures

Name	Time	Method
complete root maturation	one year	increasing the length the root till the apex closure which is determined by cone beam analysis

Trial Locations

Locations (1)

Al-Azhar university dental clinics and 6 October university dental clinics; 🇪🇬 Cairo, Choose A State Or Province, Egypt