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Silver Diamine Fluoride After Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03568474
Collaborator
(none)
40
Enrollment
2
Arms
18
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex

Condition or Disease Intervention/Treatment Phase
  • Drug: Silver Diamine Fluoride
  • Drug: Glass Ionomer
 Phase 4

Detailed Description

The study will be carried on young permanent molars with open apices & with deep caries. Incomplete caries removal and application of indirect pulp capping materials where Silver Diamine Fluoride (Group I) will be compared with glass ionomer only (group II). Then final restoration with composite resin for both groups. Children will be followed up for 9 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
parallel two arm groups with 1:1 allocation ratioparallel two arm groups with 1:1 allocation ratio
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
The participant, care provider, outcomes assessor and statistician will be masked
Primary Purpose:
Treatment
Official Title:
Postoperative Pain After Application of Silver Diamine Fluoride and Glass Ionomer Versus Glass Ionomer Alone Following Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries. A Randomized Pilot Study.
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Silver Diamine Fluoride

Silver Diamine fluoride will be applied after after minimal caries removal then glass ionomer over it followed by composite resin restoration.

Drug: Silver Diamine Fluoride
Indirect pulp capping material
Other Names:
  • SDF

    • Drug: Glass Ionomer
    Indirect pulp capping material
    Other Names:
  • GI

    		•
    Active Comparator: Glass Ionomer

    Glass ionomer will be applied after minimal caries removal followed by composite resin restoration.

    Drug: Glass Ionomer
    Indirect pulp capping material
    Other Names:
  • GI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative Pain [9 months]

      Will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)

    Secondary Outcome Measures

    1. Tooth vitality [9 months]

      Will be assessed by Vitality test using thermal stimulation, binary (yes or no)

    2. Abscess [9 months]

      Will be assessed intraoral Clinical examination whether there is swelling or not, binary (yes or no)

    3. Pain on percussion [9 months]

      Will be assessed by Percussion test by using the back of the mirror on the tooth, binary (yes or no)

    4. Root lengthening [9 months]

      Will be assessed measuring the root length by mm on the digital radiography (digora software)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:

    1. Patients free from any systematic diseases.

    2. Young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.

    3. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)

    4. The absence of clinical symptoms of irreversible pulpitis.

    5. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption).

    6. Compliant patient/ parent.

    Exclusion criteria:

    1. Teeth with previous restorative treatment.

    2. Unrestorable teeth.

    3. Uncooperative patients.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Chair: Nevine G Waly, Professor, Pediatric Dentistry, Faculty of Dentistry, Cairo University
    • Study Director: Sara A Mahmoud, PhD, Pediatric Dentistry, Faculty of Dentistry, Cairo University
    • Study Director: Mohamed K Zayt, PhD, Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University
    • Principal Investigator: Rehan A Ibrahim, MSc, Pediatric Dentistry, Faculty of Dentistry, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rehan Anwar Ibrahim, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03568474
    Other Study ID Numbers:
    • Egypt Cairo University
    First Posted:
    Jun 26, 2018
    Last Update Posted:
    Jun 26, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Fluorides

    Study Results

    No Results Posted as of Jun 26, 2018