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

Primary Purpose

Dental Pulp Exposure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Direct Pulp Capping using Dycal and Biodentine
Sponsored by
Modern Dental College and Research Centre, Indore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Exposure

Eligibility Criteria

4 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Dycal

    Biodentine

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2016
    Last Updated
    March 3, 2019
    Sponsor
    Modern Dental College and Research Centre, Indore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02789423
    Brief Title
    Clinical & Radiographical Evaluation of the Effect of Dycal & Biodentine in DPC in Primary Teeth
    Official Title
    Clinical and Radiographical Evaluation of the Effect of Calcium Hydroxide Cement (Dycal) and Calcium Silicate Cement (Biodentine) in Direct Pulp Capping in Primary Teeth: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Modern Dental College and Research Centre, Indore

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Pulp Exposure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dycal
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Biodentine
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Direct Pulp Capping using Dycal and Biodentine
    Other Intervention Name(s)
    DPC
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Evidence of effectiveness of Dycal and Biodentine as Direct Pulp Capping agent in primary molars confirmed by clinical and radiographical evaluation.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. Komal IM Gandhi, BDS
    Organizational Affiliation
    DAVV
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Dr. Mishthu Solanki, MDS
    Organizational Affiliation
    DAVV
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19201627
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23690353
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23130026
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20831133
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23270285
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23265156
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23487477
    Citation
    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.
    Results Reference
    background

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

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