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Evaluation of clinical and radiographic success and failure of MTA and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis

Evaluation of clinical and radiographic success and failure of Mineral trioxide aggregate (MTA) and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis in 3-6 years old children: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230718058836N1
Enrollment
58
Registered
2023-07-22
Start date
2023-08-06
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Irreversible pulpitis of mandibular primary molar. Pulpitis

Interventions

Intervention 1: Intervention group A: First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne XCP (DENTSPLY, USA). Film numb

Sponsors

Ilam University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Initial inclusion criteria include patients who do not have any systemic diseases such as congenital or rheumatic heart disease, leukemia, allergic reactions to substances such as local anesthetics and latex, do not need general anesthesia and sedation, have good individual and family cooperation, Deep cavity lesions whose pulp is exposed during caries removal and are vital, no history of spontaneous or nocturnal pain; Absence of clinical signs such as swelling, fistula, sensitivity to precussion or palpation, pathological mobility; teeth in which hemostasis is achieved within 5 minutes during the clinical procedure; The presence of two-thirds of the root length radiographically; and lack of radiographic evidence of pulp degeneration, such as internal or external root resorption, furca radiolucency, intraradicular or periapical bone destruction, pulp stones.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The frequency of pain in sealed primary molars. Timepoint: Three, six, nine and 12 months after treatment. Method of measurement: The patient is asked about the presence or absence of spontaneous pain after treatment (yes/no).;The percentage of frequency of occurrence of tooth sensitivity to pecussion in sealed primary molars. Timepoint: Three, six, nine and 12 months after treatment. Method of measurement: During a clinical examination with a precussion test, the patient is asked if there is any sensitivity or not.;The frequency of swelling in sealed primary molars. Timepoint: Three, six, nine and 12 months after treatment. Method of measurement: A clinical examination is performed to detect the presence or absence of swelling.;The percentage of frequency of occurrence of fistula in sealed primary molars. Timepoint: Three, six, nine and 12 months after treatment. Method of measurement: A clinical examination is performed to detect the presence or absence of fistula.;Frequency of occurrence of pathological mobility in sealed primary molars. Timepoint: Three, six, nine and 12 months after treatment. Method of measurement: A clinical examination is performed to detect the presence or absence of pathological mobility.;The frequency of occurrence of root lucency in radiographic images in sealed primary molars. Timepoint: Six and 12 months after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of lucency around the root.;Frequency of internal resortion in radiographic images of sealed primary molars. Timepoint: Six and 12 months after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of internal root resorption.;The percentage of occurrence of root external resorption in radiographic images of sealed primary molars. Timepoint: Six and 12 months after treatment. Method of measurement: Radiographic examination is performed to detect the presence or absence of ex

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPardis Sahraeian Jahromi

Ilam University of Medical Sciences

pardis.sahraj@hotmail.com+98 71 3624 7363

Outcome results

None listed

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