A Phase 1/2 interventional study of human treated dentin matrix and Mineral Tri-Oxide Aggregate in Pulpotomy of Young Permanent Molars, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Tanta University · Phase 1/2, Interventional, and Treatment
Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus MTA.
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.
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Inclusion Criteria:.
Exclusion Criteria:
drug: Human-treated dentin matrix young permanent molars treated with human-treated dentin matrix
Drug: human treated dentin matrix
Drug: Mineral Trioxide Aggregate young permanent molars treated with Mineral Trioxide Aggregate mineral trioxide aggregate was used as control
Drug: Mineral Tri-Oxide Aggregate
human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis
Also known as: human partially demineralized treated dentin matrix
mineral trioxide aggregate was used as control
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
Time frame: 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.
Time frame: 18 months
Plan to share: Undecided
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Tanta University