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Partial pulpotomy on caries free human teeth using iRootBP and White ProRoot MTA: a randomized controlled trial

Partial pulpotomy on caries free human teeth using iRootBP and White ProRoot MTA: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201102145804N2
Enrollment
24
Registered
2011-08-12
Start date
2011-06-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

pulp inflammation. Necrosis of pulp

Interventions

Intervention 1: Intervention group: Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate
Treatment - Drugs
Intervention group: Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first n
control group: partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.

Sponsors

Vice chancellor for research of Islamic Azad University, Dental Branch, Tehran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan will be included; Their parents need to read and sign a fully informed form; They shouldn't have any systematic complication or take any medicine during the period of study; The teeth need to be free of any symptom, caries and decalcification; They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant; The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion; On radiographic examination no apical lucency or PDL widening should be detected. Exclusion criteria: Any sign of crack; filling; caries or hypocalcification on teeth will cause exclusion. Also the teeth showing apical lucency or PDL widening will be excluded; Any sensitivity to cold, heat or bite will lead to exclusion; The responses beyond the normal limits to pulp vitality testing and any medicine consumption would cause exclusion.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Dentinal bridge formation. Timepoint: six weeks after intervention. Method of measurement: microscopic evaluation.;Appearance of the dentinal bridge compared to normal dentin. Timepoint: six weeks after intervention. Method of measurement: microscopic evaluation of appereance of the dentinal bridge compared to normal dentin.;Thickness of the dentinal bridge compared to normal dentin. Timepoint: six weeks after intervention. Method of measurement: microscopic evaluation of thickness of the dentinal bridge compared to normal dentin.

Secondary

MeasureTime frame
Inflammatory status of the pulp. Timepoint: six weeks after intervention. Method of measurement: microscopic evaluation : inflammatory cell count and their distribution.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahta Fazlyab

Islamic Azad University, Dental Branch, Tehran

Dr.mfazlyab@gmail.com+98 21 2275 2019

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026