Clinical and Radiographic Evaluation of Indirect Pulp Capping in Primary and Permanent Teeth With Different Materials

Evaluation of Indirect Pulp Capping in Children With Different Materials

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03606681

Enrollment

300

Registered

2018-07-31

Start date

2013-07-31

Completion date

2015-06-30

Last updated

2018-07-31

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

Conditions

Dental Pulp Capping

Keywords

Dental Pulp, calcium hydroxide, Dental Pulp Capping

Brief summary

Indirect pulp capping (IPC) is a treatment that preserves pulp's vitality. Several materials have been used for this procedure. The aim of this study is to evaluate the radiographic and clinical outcomes of TheraCal LC (Bisco Inc., Schaumburg, IL, USA) and to compare it with mineral trioxide aggregate (MTA) (Pro Root MTA, Dentsply Tulsa, Johnson City, TN, USA) and calcium hydroxide \[Ca(OH)2\] (Dycal, Dentsply De Trey Konstanz, Germany) biomaterials in IPC treatment.

Detailed description

A total of 295 teeth, including second primary molars and first permanent molars with IPC indications from healthy and cooperative children between the ages of 4-15, were included in this study. Teeth were divided into three groups according to the materials used for pulp capping. Indirect pulp treatment was applied using Dycal for 91 teeth, ProRoot MTA for 89 teeth and TheraCal LC for 115 teeth. Primary molars were restored with the compomer material, and permanent molars were restored with the resin composite material. Restorations were evaluated with the Modified United States Public Health Service (modified USPHS) criteria. Clinical and radiographic findings were evaluated for 24 months at follow-up.

Interventions

DRUGCalcium Hydroxide

After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.

DRUGMineral Trioxide Aggregate

DRUGTheraCal LC

After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 15 Years

Healthy volunteers

Yes

Inclusion criteria

* teeth with clinical and radiographical indications of indirect pulp capping * systemically healthy and cooperative children

Exclusion criteria

* teeth with contraindications of indirect pulp capping: Clinical

Design outcomes

Primary

Measure	Time frame	Description
Clinical success rates of the indirect pulp capping biomaterials	24 months	No pathological symptom like abscess, fistulas or pain at percussion

Secondary

Measure	Time frame	Description
Success rates according to Modified USPHS criterias	24 months	No failed restorations during the controls
Radiographical success rates of the indirect pulp capping biomaterials	24 months	No radiolucency or root resorption, healing with dentin bridge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026