NCT06116695

Brief Summary

Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus MTA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

October 27, 2023

Last Update Submit

July 29, 2024

Conditions

Pulpotomy of Young Permanent Molars

Outcome Measures

Primary Outcomes (2)

  • clinical outcomes

    Absence of pain related to the treated teeth, including pain or sensitivity to percussion/palpation, No evidence of swelling or presence of a sinus tract, Absence of mobility affecting the treated teeth

    18 months

  • Tomographic outcomes

    Continuous increase in root length and decrease in the apical diameter, Absence of radicular, interradicular and periradicular rarefaction, No loss of the lamina dura.

    18 months

Study Arms (2)

human-treated dentin matrix

EXPERIMENTAL

drug: Human-treated dentin matrix young permanent molars treated with human-treated dentin matrix

Drug: human treated dentin matrix

mineral tri oxide aggregate

PLACEBO COMPARATOR

Drug: Mineral Trioxide Aggregate young permanent molars treated with Mineral Trioxide Aggregate mineral trioxide aggregate was used as control

Drug: Mineral Tri-Oxide Aggregate

Interventions

human treated dentin matrixDRUG

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 Tri-Oxide AggregateDRUG

mineral trioxide aggregate was used as control

mineral tri oxide aggregate

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 21458067RESULT

  • 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: 27655430RESULT

  • 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: 29377169RESULT

  • 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: 28198096RESULT

  • Shanady NMA, Abo Hamila NA, El Maghraby GM, Ghouraba RF. Tomographic evaluation of apexogenesis with human treated dentin matrix in young permanent molars: a split-mouth randomized controlled clinical trial. BMC Oral Health. 2025 May 7;25(1):692. doi: 10.1186/s12903-025-05997-1.

    PMID: 40335983DERIVED

MeSH Terms

Interventions

TheraCal

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at pediatric dentistry oral health and preventive dentistry department

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 3, 2023

Study Start

January 18, 2022

Primary Completion

June 18, 2023

Study Completion

October 18, 2023

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

EG(1)