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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06116695
Enrollment
20
Registered
2023-11-03
Start date
2022-01-18
Completion date
2023-10-18
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpotomy of Young Permanent Molars

Brief summary

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

Detailed 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 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.

Interventions

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

mineral trioxide aggregate was used as control

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
clinical outcomes18 monthsAbsence 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
Tomographic outcomes18 monthsContinuous increase in root length and decrease in the apical diameter, Absence of radicular, interradicular and periradicular rarefaction, No loss of the lamina dura.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026