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Evaluation of success & failure of Mineral Trioxide Aggregate (MTA) & Biodentine in pulp therapy of second mandibular primary molar with irreversible pulpitis

Comparative evaluation of clinical & radiographic success & failure rate of Mineral Trioxide Aggregate (MTA) & Biodentine in pulp therapy of second mandibular primary molar with irreversible pulpitis in 3-6 years old children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210419051016N1
Enrollment
50
Registered
2021-08-09
Start date
2021-07-11
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Irreversible pulpitis of second mandibular primary molar. Pulpitis

Interventions

Intervention 1: Intervention group A: Firstly, periapical radiographic imaging with paralleling technique is provided using Rinne XCP ( DENTSPLY, USA) film holder and size 0 film with either E spee

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: No underlying systematic diseases which leads to inhibition of local anesthesia injection Having a vital second mandibular primary molar tooth with deep caries lesion in the crown that is not extended subgingivally more than 1 mm Having the history of typical pain related to the irreversible pulpitis (patient's chief complaint is spontaneous pain that lasts more than multiple seconds) Sensitivity to thermal stimuli All teeth are vital and the operator evaluates the pulp vitality by visual observation of pulp hemorrhage from all root canals of the intended tooth Having access to the participant for 12-months follow-up Pulp exposure due to severe carious crown No pathologic mobility No abscess, fistula, or swelling related to the intended tooth Possibility of restoration with Stainless Steel Crown (SSC) Possibility of providing hemostasis in the orifice entrance No internal or pathologic external root resorption No periapical radiolucency No widening in the periodontal ligament No radiolucency in furcation area No calcific degeneration of the pulp No root resorption more than 1/3 of the root length

Exclusion criteria

Exclusion criteria: Patients with underlying systemic disorders, physical, or mental disabilities Presence of any clinical or radiographic sign of pulpal degeneration including severe hemorrhage from root canals that making hemostasis impossible in 5 minutes, internal root resorption, bone resorption in furcation or preapical area, swelling or sinus tract formation, and pulp necrosis Physiologic root resorption more than 2/3 of the root length (the sign of exfoliation) Non-physiologic root resorption Non-restorable tooth

Design outcomes

Primary

MeasureTime frame
Frequency of incidence of pain in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment. Method of measurement: Patient is asked about a history of spontaneous pain after treatment (yes/no question).;Frequency of incidence of sensitivity to concussion in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment ??? ?? ? 12 ??? ?? ?? ?????. Method of measurement: Patient is asked about the presence of sensitivity while doing concussion test (yes/no question).;Frequency of incidence of swelling in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment. Method of measurement: Patient is evaluated clinically for the presence of swelling (yes/no).;Frequency of incidence of fistula formation in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment. Method of measurement: Patient is evaluated clinically for the presence of fistula (yes/no).;Frequency of incidence of pathologic mobility in sealed second mandibular primary molar. Timepoint: 3, 6, and 12 months after treatment. Method of measurement: Patient is evaluated clinically for the presence of pathologic mobility (yes/no).;Frequency of incidence of lucency around the root in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence of lucency around the root (yes/no).;Frequency of incidence of internal root resorption in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence of internal root resorption.;Frequency of incidence of external root resorption in radiographic imaging in sealed second mandibular primary molar. Timepoint: 6 and 12 months after treatment. Method of measurement: Patient is evaluated radiographically for the presence

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Maryam Hajiahmadi

Esfahan University of Medical Sciences

dr.maryamhajiahmadi@gmail.com+98 31 3792 5539

Outcome results

None listed

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