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Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236830
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Nourhan M.Aly, University of Alexandria

Brief Summary:
The aim of this study is to evaluate and compare the clinical effectiveness of 38% silver diamine fluoride with and without potassium iodide with that of resin modified glass ionomer cement in indirect pulp capping of young permanent molars.

Condition or disease Intervention/treatment Phase
Tertiary Dentine Indirect Pulp Capping Drug: Silver diamine fluoride/ potassium iodide Drug: Silver diamine fluoride Drug: Resin modified glass ionomer cement Phase 2 Phase 3

Detailed Description:
A sample of children with an age range of 6-9 years, having a first permanent molar erupted with deep occlusal carious lesion, will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 108 first permanent molars will be randomly equally allocated into three groups according to capping material used. Group I (n=36) SDF/ KI and Group II (n=36) SDF and Group III (n=36) Glass ionomer cement. Indirect pulp capping treatment procedure will be performed with identical protocols except for the capping material to be used and its application will be according to manufacturer's instructions. Glass ionomer cement will be used as a base and resin-based composite restoration will be used in the three groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a 3 arm clinical trial. All selected first permanent molars will be randomly equally allocated into three groups according to capping material used.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
Primary Purpose: Treatment
Official Title: Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial)
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Silver diamine fluoride/ potassium iodide group
Riva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia
Drug: Silver diamine fluoride/ potassium iodide
Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.
Other Name: SDF/KI

Experimental: Silver diamine fluoride group
Advantage arrest TM, Elevate Oral Care, USA
Drug: Silver diamine fluoride
Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.
Other Name: SDF

Active Comparator: Resin modified glass ionomer cement group
Riva light cure, SDI, Bayswater, Australia
Drug: Resin modified glass ionomer cement
Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.
Other Name: RMGIC




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 3 months ]
    Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  2. Postoperative pain [ Time Frame: 6 months ]
    Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  3. Postoperative pain [ Time Frame: 12 months ]
    Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  4. Tooth Vitality [ Time Frame: 3 months ]
    Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  5. Tooth Vitality [ Time Frame: 6 months ]
    Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  6. Tooth Vitality [ Time Frame: 12 months ]
    Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  7. Success of the restoration [ Time Frame: 3 months ]
    Clinical success of the whole restoration will be ranked according to Modified Ryge/USPHS Clinical Criteria (Colour, marginal adaptability, marginal staining, and secondary caries). (Moncada G, Silva F, Angel P, Oliveira Jr O, Fresno MC, Cisternas P, et al. 2014)

  8. Success of the restoration [ Time Frame: 6 months ]
    Clinical success of the whole restoration will be ranked according to Modified Ryge/USPHS Clinical Criteria (Colour, marginal adaptability, marginal staining, and secondary caries). (Moncada G, Silva F, Angel P, Oliveira Jr O, Fresno MC, Cisternas P, et al. 2014)

  9. Success of the restoration [ Time Frame: 12 months ]
    Clinical success of the whole restoration will be ranked according to Modified Ryge/USPHS Clinical Criteria (Colour, marginal adaptability, marginal staining, and secondary caries). (Moncada G, Silva F, Angel P, Oliveira Jr O, Fresno MC, Cisternas P, et al. 2014)

  10. Radiographic evaluation or root lengthening [ Time Frame: 3 months ]
    Root lengthening will be assessed by measuring the root length in mm from cement-enamel junction on standardized digital radiographs taken by parallel technique (digora software). (Flake NM, Gibbs JL, Khan AA. 2014)

  11. Radiographic evaluation or root lengthening [ Time Frame: 6 months ]
    Root lengthening will be assessed by measuring the root length in mm from cement-enamel junction on standardized digital radiographs taken by parallel technique (digora software). (Flake NM, Gibbs JL, Khan AA. 2014)

  12. Radiographic evaluation or root lengthening [ Time Frame: 12 months ]
    Root lengthening will be assessed by measuring the root length in mm from cement-enamel junction on standardized digital radiographs taken by parallel technique (digora software). (Flake NM, Gibbs JL, Khan AA. 2014)

  13. Radiographic evaluation of reparative dentin formation [ Time Frame: 3 months ]
    Reparative dentin formation, if present, will be measured in millimetre on standardized digital radiographs taken by parallel technique (digora software). (Menon NP, Varma BR, Janardhanan S, Kumaran P, Xavier AM, 2016)

  14. Radiographic evaluation of reparative dentin formation [ Time Frame: 6 months ]
    Reparative dentin formation, if present, will be measured in millimetre on standardized digital radiographs taken by parallel technique (digora software). (Menon NP, Varma BR, Janardhanan S, Kumaran P, Xavier AM, 2016)

  15. Radiographic evaluation of reparative dentin formation [ Time Frame: 12 months ]
    Reparative dentin formation, if present, will be measured in millimetre on standardized digital radiographs taken by parallel technique (digora software). (Menon NP, Varma BR, Janardhanan S, Kumaran P, Xavier AM, 2016)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For children:

  1. Children who are generally healthy.
  2. Children having a deep dentin carious lesion in a permanent first molar (upper or lower).
  3. Parents signed informed consent.

For first permanent molars:

  1. Cavitated class I carious lesions with opaque or discolored enamel exposing the dentin beneath corresponding to ICDAS II score 5 and 6 (visible dentin). (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007)
  2. Teeth having lesions that are considered active according to ICDAS II activity criteria for primary coronal caries. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
  3. Immature with open apex as revealed by periapical X-ray.

Exclusion Criteria:

For children:

  1. Any allergy reported by the parents. (Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, et al. 2017)
  2. Children unable to return for recall visits.

For first permanent molars:

  1. Any clinical signs of irreversible pulpitis (spontaneous pain, pain on percussion, abscess, sinus.
  2. Any radiographic sign of irreversible pulp pathologies or necrosis periapical radiolucency, internal or external root resorption).
  3. Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)

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): NCT04236830


Contacts
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Contact: Marwa Baraka, M.Sc 1060821280 ext +20 marwa.baraka87@gmail.com
Contact: Nourhan M Aly, BDS 1006639489 ext +20 nourhan.moustafa@alexu.edu.eg

Locations
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Egypt
Faculty of Dentistry, Alexandria University Recruiting
Alexandria, Egypt, 21512
Contact: Nourhan M Aly, BDS    (03) 4868308    dent-dean@alexu.edu.eg   
Sponsors and Collaborators
Nourhan M.Aly
Alexandria University
Investigators
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Principal Investigator: Marwa Baraka, M.Sc Faculty of Dentistry, Alexandria University, Egypt
Study Chair: Magda El-Tekeya, PhD Faculty of Dentistry, Alexandria University, Egypt
Study Chair: Niveen Bakry, PhD Faculty of Dentistry, Alexandria University, Egypt

Publications:
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Responsible Party: Nourhan M.Aly, Instructor of Dental Public Health; Statistician, University of Alexandria
ClinicalTrials.gov Identifier: NCT04236830    
Other Study ID Numbers: 0008839/00010556
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nourhan M.Aly, University of Alexandria:
Silver diamine fluoride/ potassium iodide
glass ionomer cement
Additional relevant MeSH terms:
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Dentin, Secondary
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Iodine
Fluorides
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances