Tomographic Evaluation of Pulpotomy in Young Permanent Teeth Using Human-treated Dentin Matrix

NCT ID: NCT06116695

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-10-18

Brief Summary

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

Detailed Description

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The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20 children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious young permanent mandibular first molars that are indicated for pulpotomy procedure.The selected deeply carious molars were randomly divided into two groups as follows:

Group I (Study group): 20 molars were treated with hTDM. Group II:

(Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically 3, 6, 12 and 18 months. Digital periapical radiographs was taken at 6 month follow-up period to ensure the state of the treated teeth or if there was necessary condition.

Tomographic evaluation was performed immediate postoperatively and at 18 months.

Conditions

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Pulpotomy of Young Permanent Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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human-treated dentin matrix

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

Group Type EXPERIMENTAL

human treated dentin matrix

Intervention Type DRUG

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

mineral tri oxide aggregate

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

Group Type PLACEBO_COMPARATOR

Mineral Tri-Oxide Aggregate

Intervention Type DRUG

mineral trioxide aggregate was used as control

Interventions

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human treated dentin matrix

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

Intervention Type DRUG

Mineral Tri-Oxide Aggregate

mineral trioxide aggregate was used as control

Intervention Type DRUG

Other Intervention Names

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human partially demineralized treated dentin matrix

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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nora mostafa mohammed abo shanady

Assistant lecturer at pediatric dentistry oral health and preventive dentistry department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Tanta University

Tanta, El Gharbia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 21458067 (View on PubMed)

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.

Reference Type RESULT
PMID: 27655430 (View on PubMed)

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.

Reference Type RESULT
PMID: 29377169 (View on PubMed)

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.

Reference Type RESULT
PMID: 28198096 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40335983 (View on PubMed)

Other Identifiers

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11-21-1

Identifier Type: -

Identifier Source: org_study_id

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