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

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ClinicalTrials.gov Identifier: NCT03606681

Recruitment Status : Completed

First Posted : July 31, 2018

Last Update Posted : July 31, 2018

Sponsor:

Collaborator:

Istanbul University

Information provided by (Responsible Party):

Aliye Tugce Gurcan, Altinbas University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dental Pulp Capping	Drug: Calcium Hydroxide Drug: Mineral Trioxide Aggregate Drug: TheraCal LC	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Evaluation of Indirect Pulp Capping in Children With Different Materials
Actual Study Start Date :	July 2013
Actual Primary Completion Date :	June 2014
Actual Study Completion Date :	June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Minerals

Drug Information available for: Calcium Gluconate Calcium hydroxide

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Calcium Hydroxide (Dycal) Indirect pulp capping treatment with Calcium Hydroxide	Drug: Calcium 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. Other Names: Dycal Pulp capping agent Drug: Mineral Trioxide Aggregate 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 Name: (ProRoot MTA) Drug: TheraCal 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. Other Name: resin-based calcium silicate cement
Experimental: Mineral Trioxide Aggregate (ProRoot MTA) Indirect pulp capping treatment with Mineral Trioxide Aggregate	Drug: Calcium 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. Other Names: Dycal Pulp capping agent Drug: Mineral Trioxide Aggregate 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 Name: (ProRoot MTA) Drug: TheraCal 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. Other Name: resin-based calcium silicate cement
Experimental: Theracal LC Indirect pulp capping treatment with Theracal LC	Drug: Calcium 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. Other Names: Dycal Pulp capping agent Drug: Mineral Trioxide Aggregate 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 Name: (ProRoot MTA) Drug: TheraCal 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. Other Name: resin-based calcium silicate cement

Outcome Measures

Primary Outcome Measures :

Clinical success rates of the indirect pulp capping biomaterials [ Time Frame: 24 months ]
No pathological symptom like abscess, fistulas or pain at percussion

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	4 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606681

Sponsors and Collaborators

Altinbas University

Istanbul University

Investigators

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Principal Investigator:	Aliye Tuğçe Gürcan, Assist.Prof.	Altinbas University

More Information

Publications:

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. Review.

Marchi JJ, de Araujo FB, Fröner AM, Straffon LH, Nör JE. Indirect pulp capping in the primary dentition: a 4 year follow-up study. J Clin Pediatr Dent. 2006 Winter;31(2):68-71.

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. Erratum in: J Endod. 2010 Dec;36(12):2015. Gruythuysen, René [corrected to Gruythuysen, René J M]; van Strijp, Guus [corrected to van Strijp, A J P].

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.

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.

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.

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.

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

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Responsible Party:	Aliye Tugce Gurcan, Assist. Prof., Altinbas University
ClinicalTrials.gov Identifier:	NCT03606681
Other Study ID Numbers:	35793
First Posted:	July 31, 2018 Key Record Dates
Last Update Posted:	July 31, 2018
Last Verified:	July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No

Keywords provided by Aliye Tugce Gurcan, Altinbas University:


Dental Pulp calcium hydroxide Dental Pulp Capping

Additional relevant MeSH terms:

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Calcium, Dietary Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents

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