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Completed

NCT Number: NCT03606681

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

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.

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Key information

Conditions

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 Exclusion Criteria
  • Pain (spontaneous and chronic)
  • Fistula
  • Acute pulpal inflammation
  • Pain with percussion
  • Pathologic mobility
  • Abscess
  • Devitality symptoms (negative response to thermal pulp test) Radiographic Exclusion Criteria
  • Progression of caries lesion to pulp
  • Perforation of pulp
  • Intermittent or irregular lamina dura
  • Expanded range of periodontal ligament
  • Periapical radiolucency
  • Internal and external resorption
  • systemically unhealthy and uncooperative children

Treatment and study plan

Calcium hydroxide

Drug

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.

Other names: Dycal, Pulp capping agent

Mineral Trioxide Aggregate

Drug

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 in the same session.

Other names: (ProRoot MTA)

Theracal LC

Drug

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.

Other names: resin-based calcium silicate cement

Primary outcomes

  1. Clinical success rates of the indirect pulp capping biomaterials

    Time frame: 24 months

    No pathological symptom like abscess, fistulas or pain at percussion

Secondary outcomes

  1. Success rates according to Modified USPHS criterias

    Time frame: 24 months

    No failed restorations during the controls

  2. Radiographical success rates of the indirect pulp capping biomaterials

    Time frame: 24 months

    No radiolucency or root resorption, healing with dentin bridge

Sponsors and collaborators

Lead sponsor

Altinbas University

Other

Collaborators

  • Istanbul University

Registry information

Official study title

Evaluation of Indirect Pulp Capping in Children With Different Materials

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 31, 2018
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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