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

Dentin Bridge Clinical Trial

Official title:

Clinical, Radiographic and Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05830695
• Other study ID #: 12-3456
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 18, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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 vital pulp therapy.The selected deeply carious molars were randomly divided into two groups as follows:

Group I (Study group): 20 molars were treated with human TDM. Group II: (Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically and radiographically after 6, 12 and 18 months. Tomographic evaluation was performed immediate postoperatively and at 18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2023
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Bridge

Intervention

Drug:
• human treated dentin matrix
human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis
• Mineral Trioxide Aggregate
mineral trioxide aggregate was used as control

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Tanta University	Tanta	El Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
nora mostafa mohammed abo shanady

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcome	patient reported pain or tenderness on palpation or percussion	18 months
Primary	clinical outcome	patient/ clinician observed swelling or sinus tract observation	18 months
Primary	clinical outcome	tooth mobility clinically assessed by grades	18 months
Primary	radiographic outcomes	radicular changes assessed by clinician from digital periapical radiograph	18 months
Primary	radiographic outcomes	interradicular changes assessed by clinician from digital periapical radiograph	18 months
Primary	radiographic outcomes	peri-radicular changes assessed by clinician from digital periapical radiograph	18 months
Primary	tomographic evaluation	evidence of continuity of root development measured from cone beam computed tomography	18 months