Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars

NCT05830695 | Completed Phase 1

• 1 other identifier: 12-3456
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA.

Conditions

Dentin Bridge

Outcome Measures

Primary Outcomes (7)

• clinical outcome

  patient reported pain or tenderness on palpation or percussion

  18 months

• clinical outcome

  patient/ clinician observed swelling or sinus tract observation

  18 months

• clinical outcome

  tooth mobility clinically assessed by grades

  18 months

• radiographic outcomes

  radicular changes assessed by clinician from digital periapical radiograph

  18 months

• radiographic outcomes

  interradicular changes assessed by clinician from digital periapical radiograph

  18 months

• radiographic outcomes

  peri-radicular changes assessed by clinician from digital periapical radiograph

  18 months

• tomographic evaluation

  evidence of continuity of root development measured from cone beam computed tomography

  18 months

Study Arms (2)

human treated dentin matrix

EXPERIMENTAL

study group

Drug: human treated dentin matrix

mineral tri oxide aggregate

EXPERIMENTAL

control group

Drug: Mineral Trioxide Aggregate

Interventions

human treated dentin matrix DRUG

human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis

Also known as: human partially demineralized treated dentin matrix

human treated dentin matrix

Mineral Trioxide Aggregate DRUG

mineral trioxide aggregate was used as control

Also known as: MTA

mineral tri oxide aggregate

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Bilateral immature permanent mandibular first molars with deep carious lesions.
• Positive response to pulp testing.
• Normal radiographic appearance.
• Healthy children without any systemic disease that interferes with pulp healing.
• Patient and parent cooperation.

You may not qualify if:

• Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.
• Presence of periapical lesion, external or internal root resorption.
• Carious furcation involvement.
• Dystrophic calcification of the pulp.
• Non restorable tooth.

Sponsors & Collaborators

• nora mostafa mohammed abo shanady: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, El Gharbia, 31111, Egypt

Location

Related Publications (5)

• Li R, Guo W, Yang B, Guo L, Sheng L, Chen G, Li Y, Zou Q, Xie D, An X, Chen Y, Tian W. Human treated dentin matrix as a natural scaffold for complete human dentin tissue regeneration. Biomaterials. 2011 Jul;32(20):4525-38. doi: 10.1016/j.biomaterials.2011.03.008. Epub 2011 Mar 31.

  PMID: 21458067 BACKGROUND

• Tabatabaei FS, Tatari S, Samadi R, Torshabi M. Surface characterization and biological properties of regular dentin, demineralized dentin, and deproteinized dentin. J Mater Sci Mater Med. 2016 Nov;27(11):164. doi: 10.1007/s10856-016-5780-8. Epub 2016 Sep 21.

  PMID: 27655430 BACKGROUND

• Widbiller M, Eidt A, Wolflick M, Lindner SR, Schweikl H, Hiller KA, Buchalla W, Galler KM. Interactive effects of LPS and dentine matrix proteins on human dental pulp stem cells. Int Endod J. 2018 Aug;51(8):877-888. doi: 10.1111/iej.12897. Epub 2018 Feb 17.

  PMID: 29377169 BACKGROUND

• Chen J, Cui C, Qiao X, Yang B, Yu M, Guo W, Tian W. Treated dentin matrix paste as a novel pulp capping agent for dentin regeneration. J Tissue Eng Regen Med. 2017 Dec;11(12):3428-3436. doi: 10.1002/term.2256. Epub 2017 Feb 15.

  PMID: 28198096 BACKGROUND

• Mehrvarzfar P, Abbott PV, Mashhadiabbas F, Vatanpour M, Tour Savadkouhi S. Clinical and histological responses of human dental pulp to MTA and combined MTA/treated dentin matrix in partial pulpotomy. Aust Endod J. 2018 Apr;44(1):46-53. doi: 10.1111/aej.12217. Epub 2017 Aug 18.

  PMID: 28833942 BACKGROUND

MeSH Terms

Interventions

mineral trioxide aggregate; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer at pediatric dentistry oral health and preventive dentistry department

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 26, 2023
• Study Start: January 18, 2022
• Primary Completion: July 18, 2022
• Study Completion: March 31, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)