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CompletedNCT02789423Updated Mar 5, 2019

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

An interventional study of Direct Pulp Capping using Dycal and Biodentine in Dental Pulp Exposure, sponsored by Modern Dental College and Research Centre, Indore. Completed. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Modern Dental College and Research Centre, Indore · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
4 Years to 9 Years
Sex
All
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Study 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.

Read the detailed description

The aim of the present study is to compare Calcium Hydroxide cement (Dycal) ® and Calcium Silicate cement (Biodentine)TM as pulp capping agents in primary molars. The objective of this study include the evaluation of clinical and radiographic efficacy of Calcium Hydroxide cement (Dycal) ® and Calcium Silicate cement (Biodentine)TM, and their response in direct pulp capping treatment on primary molars during a 6 months follow up. After following the proper standardized procedure for direct pulp cap. In the current study direct pulp capping was performed using calcium hydroxide cement (Dycal)® and Calcium Silicate cement (Biodentine)TM on 60 primary teeth of children equally divided between 2 study groups randomly of both the sexes aged 4-9 years old. Complete case history was recorded in detail and intraoral periapical radiograph was also taken for teeth indicated for direct pulp capping. Written consent was obtained from the parents of participants before starting the procedure. Strict standardized procedure had been followed and the pulp capping agent (Dycal®/BiodentineTM) were applied according to the manufacturer's instructions.Each patient was evaluated clinically and radiographically for any abnormal clinical signs and symptoms at 1,3 and 6 months postoperatively.Better results for the success of the study could be relatively enhanced by close attention to rigid criteria for case selection, standardization of direct pulp capping procedure and meticulous performance of the procedure appear to be prerequisites for successful treatment.

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Conditions studied

  • Dental Pulp Exposure

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03

In context

Dental Pulp Exposure

29 studies on the registry are indexed under Dental Pulp Exposure; 5 are open to participants now.

This study's enrollment of 60 is above the median of 53 across 27 interventional studies indexed under Dental Pulp Exposure.

Browse Dental Pulp Exposure studies →

Lead sponsor

This is the only study on the registry with Modern Dental College and Research Centre, Indore as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Good health.
  2. Cooperative behaviour.
  3. Informed consent from parents.
  4. Primary molars with clinically active caries.
  5. No history of spontaneous pain in teeth.
  6. Restorable tooth with at least one half of root length present.
  7. Absence of pathological mobility.
  8. Absence of tenderness to percussion.
  9. 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Dycal

    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

  • Active comparator
    Biodentine

    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

  • ProcedureDirect Pulp Capping using Dycal and Biodentine

    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

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What researchers measure

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.

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 19201627 ↗
  • 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. PubMed 23690353 ↗
  • 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. PubMed 23130026 ↗
  • 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. PubMed 20831133 ↗
  • 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. PubMed 23270285 ↗
  • 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. PubMed 23265156 ↗
  • 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. PubMed 23487477 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02789423
Lead sponsor
Modern Dental College and Research Centre, Indore
Responsible party
Dr. Komal Gandhi (Post Graduate, Modern Dental College and Research Centre, Indore) — Principal investigator
First posted
Jun 3, 2016
Start date
Jun 2013
Primary completion
Jul 2015
Completion
Dec 2015
Last update
Mar 5, 2019

Study contacts

Dr. Komal IM Gandhi, BDS
principal investigator · DAVV
Dr. Mishthu Solanki, MDS
study chair · DAVV

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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