NCT03606681

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

July 2, 2018

Last Update Submit

July 23, 2018

Conditions

Dental Pulp Capping

Keywords

Dental Pulpcalcium hydroxideDental Pulp Capping

Outcome Measures

Primary Outcomes (1)

  • Clinical success rates of the indirect pulp capping biomaterials

    No pathological symptom like abscess, fistulas or pain at percussion

    24 months

Secondary Outcomes (2)

  • Success rates according to Modified USPHS criterias

    24 months

  • Radiographical success rates of the indirect pulp capping biomaterials

    24 months

Study Arms (3)

Calcium Hydroxide (Dycal)

ACTIVE COMPARATOR

Indirect pulp capping treatment with Calcium Hydroxide

Drug: Calcium HydroxideDrug: Mineral Trioxide AggregateDrug: TheraCal LC

Mineral Trioxide Aggregate (ProRoot MTA)

EXPERIMENTAL

Indirect pulp capping treatment with Mineral Trioxide Aggregate

Drug: Calcium HydroxideDrug: Mineral Trioxide AggregateDrug: TheraCal LC

Theracal LC

EXPERIMENTAL

Indirect pulp capping treatment with Theracal LC

Drug: Calcium HydroxideDrug: Mineral Trioxide AggregateDrug: TheraCal LC

Interventions

Calcium HydroxideDRUG

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.

Also known as: Dycal, Pulp capping agent
Calcium Hydroxide (Dycal)Mineral Trioxide Aggregate (ProRoot MTA)Theracal LC
Mineral Trioxide AggregateDRUG

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.

Also known as: (ProRoot MTA)
Calcium Hydroxide (Dycal)Mineral Trioxide Aggregate (ProRoot MTA)Theracal LC
TheraCal LCDRUG

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.

Also known as: resin-based calcium silicate cement
Calcium Hydroxide (Dycal)Mineral Trioxide Aggregate (ProRoot MTA)Theracal LC

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Pain (spontaneous and chronic)
  • Fistula
  • Acute pulpal inflammation
  • Pain with percussion
  • Pathologic mobility
  • Abscess
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Fuks AB. Vital pulp therapy with new materials for primary teeth: new directions and treatment perspectives. J Endod. 2008 Jul;34(7 Suppl):S18-24. doi: 10.1016/j.joen.2008.02.031.

    PMID: 18565366BACKGROUND

  • Marchi JJ, de Araujo FB, Froner AM, Straffon LH, Nor JE. Indirect pulp capping in the primary dentition: a 4 year follow-up study. J Clin Pediatr Dent. 2006 Winter;31(2):68-71. doi: 10.17796/jcpd.31.2.y4um5076341226m5.

    PMID: 17315796BACKGROUND

  • Gruythuysen RJ, van Strijp AJ, Wu MK. Long-term survival of indirect pulp treatment performed in primary and permanent teeth with clinically diagnosed deep carious lesions. J Endod. 2010 Sep;36(9):1490-3. doi: 10.1016/j.joen.2010.06.006.

    PMID: 20728715BACKGROUND

  • Gandolfi MG, Siboni F, Prati C. Chemical-physical properties of TheraCal, a novel light-curable MTA-like material for pulp capping. Int Endod J. 2012 Jun;45(6):571-9. doi: 10.1111/j.1365-2591.2012.02013.x. Epub 2012 Mar 31.

    PMID: 22469093BACKGROUND

  • Kotsanos N, Arizos S. Evaluation of a resin modified glass ionomer serving both as indirect pulp therapy and as restorative material for primary molars. Eur Arch Paediatr Dent. 2011 Jun;12(3):170-5. doi: 10.1007/BF03262801.

    PMID: 21640064BACKGROUND

  • Al-Zayer MA, Straffon LH, Feigal RJ, Welch KB. Indirect pulp treatment of primary posterior teeth: a retrospective study. Pediatr Dent. 2003 Jan-Feb;25(1):29-36.

    PMID: 12627699BACKGROUND

  • George V, Janardhanan SK, Varma B, Kumaran P, Xavier AM. Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study). J Indian Soc Pedod Prev Dent. 2015 Apr-Jun;33(2):104-10. doi: 10.4103/0970-4388.155118.

    PMID: 25872627BACKGROUND

  • Casagrande L, Bento LW, Dalpian DM, Garcia-Godoy F, de Araujo FB. Indirect pulp treatment in primary teeth: 4-year results. Am J Dent. 2010 Feb;23(1):34-8.

    PMID: 20437725BACKGROUND

MeSH Terms

Interventions

Calcium HydroxideDycalPulp Capping and Pulpectomy Agentsmineral trioxide aggregateProRoot MTA

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytesDental MaterialsBiomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Aliye Tuğçe Gürcan, Assist.Prof.

    Altinbas University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 31, 2018

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share