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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04005872
Collaborator
(none)
50
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

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
  • Drug: Nano Silver Fluoride
  • Drug: Calcium hydroxide
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 hydroxideThis 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
Anticipated Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Sep 30, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • CaoH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Spontaneous pain or pain on biting [12 months]

      By asking patient

    2. Pain on percussion [12 months]

      By the back of mirror

    3. Swelling [12 months]

      Clinical examination by operator

    4. Mobility [12 months]

      Clinical examination by operator

    5. Sinus or fistula tract [12 months]

      Clinical examination by operator

    Secondary Outcome Measures

    1. Furcation or perapical radiolucency [12 months]

      Periapical radiograph

    2. External or internal root resorption [12 months]

      Periapical radiograph

    3. Widening periodontal membrane space [12 months]

      Periapical radiograph

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heba Moahmed Fouad, Specialist, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04005872
    Other Study ID Numbers:
    • Cairo U E
    First Posted:
    Jul 2, 2019
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Calcium
    Fluorides

    Study Results

    No Results Posted as of Jul 5, 2019