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Comparison of effect of Protooth and Mineral Trioxide Aggregate in Direct pulp capping of primary molars

Comparison of the effect of novel fast setting calcium silicate cement containing fluoride (Protooth) and Mineral Trioxide Aggregate in direct pulp capping of primary molars; A split mouth randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100125003168N6
Enrollment
45
Registered
2018-11-02
Start date
2018-10-01
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Dental caries. Dental caries

Interventions

Intervention 1: Intervention group:The effect of Protooth (Ultrafast Protooth, Dentosolve, Aarhus, Denmark) in direct pulp capping of primary molars. This material was applied by using its own commerc

Sponsors

Reasearch Vice-Chancellor- Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 8 Years

Inclusion criteria

Inclusion criteria: 5-8 years old children Having a pair of symmetric second primary molar teeth in one jaw having deep caries and vital pulp Capable of being restored by amalgam filling No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test Complete physical and mental health with no confounding history of systemic disease and/or use of special local or systemic drugs; No allergic reactions recorded in patient history No sign of radiolucency in periapical or furcation area No widening of PDL space or loss of lamina dura continuity No evidence of internal/external pathologic root resorption

Exclusion criteria

Exclusion criteria: Lack of informed consent by the child patient’s parent Abnormal bleeding at the site of pulp exposure (i.e. bleeding which lasts for more than 3 minutes) No evidence of pulp exposure at the site of caries excavation in symmetric second primary molar teeth, which were conventionally restored with an amalgam filling and excluded from our study Evidence of pulp exposure surrounded by carious dentin which is indicative of pulpal contamination

Design outcomes

Primary

MeasureTime frame
Dental pulp vitality after treatment. Timepoint: 6 &12 months. Method of measurement: Lack of any of clinical or radiographic signs or symptoms of treatment failure.

Secondary

MeasureTime frame
Radiographic success. Timepoint: 6&12 months. Method of measurement: Presence of one or more of the following radiographic signs will be considered as failure of treatment: internal and/or external root resorption, periodontal space widening, inter-radicular radiolucency, and periapical lesions.;Clinical success. Timepoint: 6 &12 months. Method of measurement: Presence of one or more of the following clinical signs/symptoms will be considered as failure of treatment: spontaneous pain, swelling, pathologic mobility, tenderness to pressure, and presence of sinus tract, swelling, and sensitivity to percussion.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ali Vafaie

Tabriz University of Medical Sciences

alivafaiitbzmed@gmail.com+98 413355965

Outcome results

None listed

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