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

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ClinicalTrials.gov Identifier: NCT03568474
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Rehan Anwar Ibrahim, Cairo University

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
Deep Caries 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel 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.
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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 Name: SDF

Drug: Glass Ionomer
Indirect pulp capping material
Other Name: 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 Name: GI




Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 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 [ Time Frame: 9 months ]
    Will be assessed by Vitality test using thermal stimulation, binary (yes or no)

  2. Abscess [ Time Frame: 9 months ]
    Will be assessed intraoral Clinical examination whether there is swelling or not, binary (yes or no)

  3. Pain on percussion [ Time Frame: 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 [ Time Frame: 9 months ]
    Will be assessed measuring the root length by mm on the digital radiography (digora software)



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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03568474


Contacts
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Contact: Rehan Anwar, MSc +201210339553 rehananwar28@hotmail.com
Contact: Sara A Mahmoud, PhD +201000042564 sara_yn79@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
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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

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Responsible Party: Rehan Anwar Ibrahim, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03568474     History of Changes
Other Study ID Numbers: Egypt Cairo University
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: thesis and article publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: after cessation of the study
Access Criteria: Internet

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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:
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Fluorides
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Cariostatic Agents
Protective Agents