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

• Sponsor: Al-Azhar University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05790629
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20.8
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Deep Carious Young 1st Permanent Molar With Open Apex	Procedure: endo-sequence putty; Procedure: neo-MTA putty	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: children do not know which material used
• Primary Purpose: Treatment
• Official Title: Three Dimensional Evaluation of Apexogenesis of Immature Young Permanent Teeth With Different Endodontic Tri-calcium Silicate-Based Putties: Randomized Clinical Trial
• Actual Study Start Date: Aug 8, 2022
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group (I) control 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.	Procedure: endo-sequence putty; pupal medicament which is materials used in case of vital pulp therapy (VPT) procedure after opening access in the inflamed pulp to maintain it is vitality, inducing dentin bridge formation and encourage continued root maturation.; Other Names: Endodontic Tri-calcium Silicate-Based Puty
Experimental: Group (II) 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.	Procedure: neo-MTA putty; pupal medicament which is materials used in case of vital pulp therapy (VPT) procedure after opening access in the inflamed pulp to maintain it is vitality, inducing dentin bridge formation and encourage continued root maturation.; Other Names: Endodontic Tri-calcium Silicate-Based Puty

Outcome Measures

Primary Outcome Measures

1. 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

1. complete root maturation [one year]

   increasing the length the root till the apex closure which is determined by cone beam analysis

Other Outcome Measures

1. maintain pulp vitality [one year]

   Positive response to sensibility testing. it evaluates the condition of the Pulp Being Very Responsive to a hot and cold Stimulus The pulp is deemed normal when there is a response to the stimulus. Pulpitis is present when there is an exaggerated response that produces pain. The absence of responses to sensibility tests is usually associated with the likelihood of pulp necrosis, the tooth is pulpless,

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar university dental clinics and 6 October university dental clinics	Cairo	Choose A State Or Province	Egypt	00040

Sponsors and Collaborators

• Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa M Eldehna, lecturer of Pediatric dentistry, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05790629
• Other Study ID Numbers: P-PD-22-26
• First Posted: Mar 30, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Calcium, Dietary; Calcium

Study Results

No Results Posted as of Mar 30, 2023