Skip to content

Comparison of the effect of TheraCal-LC® and Mineral Trioxide Aggregate in direct pulp capping of primary molars in 5-8 year old children.

Comparison of the effect of TheraCal-LC® and Mineral Trioxide Aggregate in direct pulp capping of primary molars in 5-8 year old children. A split-mouth randomized controlled clinical Trial .

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201602063168N3
Enrollment
90
Registered
2017-02-10
Start date
2016-10-06
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

dental caries. Caries of dentine

Interventions

Intervention 1: Study group: The effect of TheraCal LC (Bisco Inc., Schamburg, IL, USA) in direct pulp capping of primary molars. This material was applied by using its own commercial instrument with
Treatment - Other
Control group: The effect of MTA (ProRoot
Study group: The effect of TheraCal LC (Bisco Inc., Schamburg, IL, USA) in direct pulp capping of primary molars. This material was applied by using its own commercial instrument with a rounded tip in

Sponsors

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

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 5-8 years old children; 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; Having a pair of symmetric second primary molar teeth in one jaw having deep caries and vital pulp which is 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; 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: Lack of informed consent by the child patient’s parent; No evidence of pulp exposure at the site of caries excavation in 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; Abnormal bleeding at the site of pulp exposure (i.e. bleeding with dark color which lasts for more than 3 minutes despite application of wet cotton pellet with mild pressure).

Exclusion criteria

Exclusion criteria:

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 Vafai

Dentistry faculty, Tabriz University of Medical Sciences

alivafaiitbzmed@gmail.com+98 41 3335 5965

Outcome results

None listed

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