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Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial (RCT)

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ClinicalTrials.gov Identifier: NCT04005872
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Heba Moahmed Fouad, Cairo University

Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 5, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Spontaneous pain or pain on biting [ Time Frame: 12 months ]
    By asking patient
  • Pain on percussion [ Time Frame: 12 months ]
    By the back of mirror
  • Swelling [ Time Frame: 12 months ]
    Clinical examination by operator
  • Mobility [ Time Frame: 12 months ]
    Clinical examination by operator
  • Sinus or fistula tract [ Time Frame: 12 months ]
    Clinical examination by operator
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Sontaneous pain or pain on biting assessed by binary [ Time Frame: 12 months ]
    By asking patient
  • Pain on percussion [ Time Frame: 12 months ]
    By the back of mirror
  • Swelling [ Time Frame: 12 months ]
    Clinical examination by operator
  • Mobility [ Time Frame: 12 months ]
    Clinical examination by operator
  • Sinus or fistula tract [ Time Frame: 12 months ]
    Clinical examination by operator
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Furcation or perapical radiolucency [ Time Frame: 12 months ]
    Periapical radiograph
  • External or internal root resorption [ Time Frame: 12 months ]
    Periapical radiograph
  • Widening periodontal membrane space [ Time Frame: 12 months ]
    Periapical radiograph
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial
Official Title  ICMJE Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment
Brief Summary The management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity.
Detailed Description

This study is designed to assess the clinical and radiographic effectivness of nano silver fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second primary molars. This clinical study is important because World Health Organization (WHO) has reported that school children experience to dental caries was 60-90% of worldwide (P. D. Garkoti et al., 2015).

This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide (Metalita M et al., 2016).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Eligible consented participants will be randomly assigned to know which side of the participant (right or left) will be control or intervention group according to a sequence generated on a Microsoft Excel sheet where the intervention (I) and the control (C) are simply randomized.
Primary Purpose: Treatment
Condition  ICMJE Deep Caries
Intervention  ICMJE
  • Drug: Nano Silver Fluoride
    Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.
    Other Name: NSF
  • Drug: Calcium hydroxide
    Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.
    Other Name: CaoH
Study Arms  ICMJE
  • Experimental: Nano Silver Fluoride
    2 drops of nano silver fluoride (NSF) applied on the last soft carious layer using micro brush
    Intervention: Drug: Nano Silver Fluoride
  • Active Comparator: Calcium Hydroxide
    Calcium hydroxide placed on the last soft carious layer approaching the pulp
    Intervention: Drug: Calcium hydroxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients:

  • Cooperative children.
  • Both genders.
  • In age range from 4 to 7 years.

Teeth:

  • Vital second primary molars with deep caries limited to occlusal surface.
  • No clinical signs or symptoms of irreversible pulpitis or pulp necrosis.
  • No radiographic abnormalities
  • Restorable teeth.

Exclusion Criteria:

  • • Children with known history of allergy to any of the tested materials.

    • Children with systemic conditions.
    • Parents who refused to participate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005872
Other Study ID Numbers  ICMJE Cairo U E
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Clinical and Radiographic Evaluation of Nano Silver Fluoride versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars
Responsible Party Heba Moahmed Fouad, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP