Clinical & Radiographical Evaluation of the Effect of Dycal & Biodentine in DPC in Primary Teeth

NCT02789423 | Completed

• 1 other identifier: ModernDCRC
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was clinical and radiographical evaluation of the effect of calcium hydroxide cement (Dycal) and calcium silicate cement (Biodentine) in direct pulp capping in primary teeth.

Conditions

Dental Pulp Exposure

Outcome Measures

Primary Outcomes (1)

• Evidence of effectiveness of Dycal and Biodentine as Direct Pulp Capping agent in primary molars confirmed by clinical and radiographical evaluation.

  Clinical Criteria: No spontaneous pain,Defective restoration/Recurrent caries,Sinus formation,TOP,Soft tissue swelling \& Mobility. Radiographic criteria: No Defective restoration/Recurrent caries,Periapical or furcal radiolucency,Pathological internal resorption,Replacement resorption,Intracanal calcification \& Physiological resorption.

  6 months

Study Arms (2)

Dycal

ACTIVE COMPARATOR

Intervention: drug: Dycal, Other names: Calcium Hydroxide. Intervention Description:DPC using Dycal for direct pulp exposure was performed in 30 primary molar teeth after proper case selection.Clinical and radiographic evaluation was done.One month post operative criteria evaluated were-Clinical criteria:Spontaneous pain,Defective restoration/Recurrent caries,Sinus formation,TOP,Soft tissue swelling \& Mobility. Radiographic criteria:Defective restoration/Recurrent caries,Periapical or furcal radiolucency,Pathological internal resorption,Replacement resorption,Intracanal calcification \& Physiological resorption.The follow-up was at 3 and 6 months.

Procedure: Direct Pulp Capping using Dycal and Biodentine

Biodentine

ACTIVE COMPARATOR

Intervention: drug: Biodentine, Other names: Calcium Silicate. Intervention Description:DPC using Biodentine for direct pulp exposure was performed in 30 primary molar teeth after proper case selection.Clinical and radiographic evaluation was done.One month post operative criteria were-Clinical criteria:Spontaneous pain,Defective restoration/Recurrent caries,Sinus formation,TOP,Soft tissue swelling \& Mobility.Radiographic criteria:Defective restoration/Recurrent caries, Periapical or furcal radiolucency,Pathological internal resorption,Replacement resorption,Intracanal calcification \& Physiological resorption.The follow-up was at 3 and 6 months.

Procedure: Direct Pulp Capping using Dycal and Biodentine

Interventions

Direct Pulp Capping using Dycal and Biodentine PROCEDURE

The operative procedure performed as follows: i)Administration of L.A and rubber dam isolation. ii)High-speed carious enamel removal. iii)Dentine mechanical curettage. iv)Manual final dentine curettage using a spoon excavator. v)Hemorrhage control by cotton pellet moistened with 2.5% sodium hypochlorite placed over the exposure for 1-2min. vi)The exposure site would then be dried with sterile cotton pellet.The operator shall apply the pulp capping agent(dycal/Biodentine)according to the manufacturer's instructions.And then another cover of glass ionomer is applied.This would be followed by permanent restoration.

Also known as: DPC

Biodentine; Dycal

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Good health.
• Cooperative behaviour.
• Informed consent from parents.
• Primary molars with clinically active caries.
• No history of spontaneous pain in teeth.
• Restorable tooth with at least one half of root length present.
• Absence of pathological mobility.
• Absence of tenderness to percussion.
• Normal gingiva and periodontal condition without the sign of pathology such as redness and swelling of vestibule, draining sinus tract or sensitivity to palpate in the vestibule.
• In addition, the teeth treated by direct pulp capping had only a pin point mechanical exposure (0.5 to 1mm), for which haemorrhage control could be achieved within two minutes before proceeding with direct pulp capping.
• Radiographically, there was absence of internal resorption, external resorption, periapical or furcation radiolucencies and pathology of succedenous permanent tooth follicle.

You may not qualify if:

• Patients with a history of spontaneous pain, tooth tender to percussion, absence of underlying permanent teeth, internal/external root resorption, apical/furcal lesions, sinus tract, physiologic or pathologic luxation, and/or presence of abscess were excluded from the study.

Sponsors & Collaborators

• Modern Dental College and Research Centre, Indore: lead

Related Publications (7)

• Garrocho-Rangel A, Flores H, Silva-Herzog D, Hernandez-Sierra F, Mandeville P, Pozos-Guillen AJ. Efficacy of EMD versus calcium hydroxide in direct pulp capping of primary molars: a randomized controlled clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 May;107(5):733-8. doi: 10.1016/j.tripleo.2008.12.017. Epub 2009 Feb 8.

  PMID: 19201627 BACKGROUND

• Hilton TJ, Ferracane JL, Mancl L; Northwest Practice-based Research Collaborative in Evidence-based Dentistry (NWP). Comparison of CaOH with MTA for direct pulp capping: a PBRN randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):16S-22S. doi: 10.1177/0022034513484336. Epub 2013 May 20.

  PMID: 23690353 BACKGROUND

• Fallahinejad Ghajari M, Asgharian Jeddi T, Iri S, Asgary S. Direct pulp-capping with calcium enriched mixture in primary molar teeth: a randomized clinical trial. Iran Endod J. 2010 Winter;5(1):27-30. Epub 2010 Feb 20.

  PMID: 23130026 BACKGROUND

• Aminabadi NA, Farahani RM, Oskouei SG. Formocresol versus calcium hydroxide direct pulp capping of human primary molars: two year follow-up. J Clin Pediatr Dent. 2010 Summer;34(4):317-21. doi: 10.17796/jcpd.34.4.pntq604021604234.

  PMID: 20831133 BACKGROUND

• Tuzuner T, Alacam A, Altunbas DA, Gokdogan FG, Gundogdu E. Clinical and radiographic outcomes of direct pulp capping therapy in primary molar teeth following haemostasis with various antiseptics: a randomised controlled trial. Eur J Paediatr Dent. 2012 Dec;13(4):289-92.

  PMID: 23270285 BACKGROUND

• Shayegan A, Jurysta C, Atash R, Petein M, Abbeele AV. Biodentine used as a pulp-capping agent in primary pig teeth. Pediatr Dent. 2012 Nov-Dec;34(7):e202-8.

  PMID: 23265156 BACKGROUND

• Asl Aminabadi N, Maljaei E, Erfanparast L, Ala Aghbali A, Hamishehkar H, Najafpour E. Simvastatin versus Calcium Hydroxide Direct Pulp Capping of Human Primary Molars: A Randomized Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2013 Winter;7(1):8-14. doi: 10.5681/joddd.2013.002. Epub 2013 Feb 21.

  PMID: 23487477 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

tricalcium silicate

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dr. Komal IM Gandhi, BDS

  DAVV

  PRINCIPAL INVESTIGATOR

• Dr. Mishthu Solanki, MDS

  DAVV

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: June 3, 2016
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share