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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

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.

Condition or disease Intervention/treatment Phase
Deep Caries Drug: Nano Silver Fluoride Drug: Calcium hydroxide Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Nano Silver Fluoride
2 drops of nano silver fluoride (NSF) applied on the last soft carious layer using micro brush
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

Active Comparator: Calcium Hydroxide
Calcium hydroxide placed on the last soft carious layer approaching the pulp
Drug: Calcium hydroxide
Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.
Other Name: CaoH




Primary Outcome Measures :
  1. Spontaneous pain or pain on biting [ Time Frame: 12 months ]
    By asking patient

  2. Pain on percussion [ Time Frame: 12 months ]
    By the back of mirror

  3. Swelling [ Time Frame: 12 months ]
    Clinical examination by operator

  4. Mobility [ Time Frame: 12 months ]
    Clinical examination by operator

  5. Sinus or fistula tract [ Time Frame: 12 months ]
    Clinical examination by operator


Secondary Outcome Measures :
  1. Furcation or perapical radiolucency [ Time Frame: 12 months ]
    Periapical radiograph

  2. External or internal root resorption [ Time Frame: 12 months ]
    Periapical radiograph

  3. Widening periodontal membrane space [ Time Frame: 12 months ]
    Periapical radiograph



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Heba Moahmed Fouad, Specialist, Cairo University
ClinicalTrials.gov Identifier: NCT04005872    
Other Study ID Numbers: Cairo U E
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
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

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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
Additional relevant MeSH terms:
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Calcium
Fluorides
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents