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Effect of Different Over-the-counter Toothpastes on Enamel Remineralization (RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03774498
Recruitment Status : Unknown
Verified December 2018 by Mohammed Farag Abd El-Khalek kelany, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Information provided by (Responsible Party):
Mohammed Farag Abd El-Khalek kelany, Cairo University

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 13, 2018
Last Update Posted Date December 13, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
Enamel remineralization [ Time Frame: 8 weeks ]
Decalcification index: (0):No white spot ,(1):Visible white spots ,no surface interruption (mild),(2):Visible white spot with roughened surface,not require restoration (moderate),(3):Visible with surface interruption (severe), (4):Cavitation. International Caries Detection and Assessment System:(0):Sound tooth surface: No evidence of caries after 5 sec air drying ,(1):First visual change in enamel: Opacity or white or brown discoloration visible after prolonged drying,(2):Distinct change in enamel visible when wet, must be visible when dry,(3):Localized enamel breakdown (no visual signs of dentin involvement) seen when wet and after prolonged drying,(4):Underlying dark shadow from dentine,(5):Distinct cavity with visible dentine,(6): Extensive (more than half the surface) cavity with visible dentine. Scoring is done by photographs at the beginning and at follow-up visits with the same setting each time.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of Different Over-the-counter Toothpastes on Enamel Remineralization
Official Title  ICMJE Effect of Different Over-the-counter Toothpastes on Enamel Remineralization: A Double Blinded Randomized Clinical Trial
Brief Summary This study will be conducted to compare between recent over-the-counter toothpaste (Novamin & Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.
Detailed Description

Statement of problem:

Dental caries has been recognized as a dynamic process that results from an imbalance between the physiologic demineralization and remineralization of tooth structure. It has been well established that tooth undergoes cyclic demineralization of enamel crystals with periods of remineralization resulting from re-precipitation of calcium and phosphate ions from the saliva. If the process of demineralization dominates, caries result. However, if remineralization dominates along with removal of bacterial infection, enamel integrity gets restored. This basic knowledge of carious process brings us to an understanding that by controlling the amount, pattern and rhythm of demineralization and remineralization, carious lesions can either be controlled from progressing further or can be reversed. Several decades ago it was noted that clinically detectable white-spot lesions could be hardened; various scientific methods have been advocated for arrest and the reversal of incipient caries lesion by either decreasing the solubility of the mineral present or by increasing the mineral content of the previously demineralized tooth. Since remineralization occurring naturally in oral environment is often inadequate for maintaining strong decay free enamel and dentin, the process needs to be augmented by using some external means. It has been proposed that a simultaneous supply of calcium, phosphate and fluoride ions might serve as an invaluable tool to remineralize and strengthen the tooth structure by formation of calcium fluorapatite. Fluoride as a constituent of drinking water and in the form of various topically applied products especially over-the-counter toothpastes have a long successful history of use as a caries preventive agent.

NovaMin is claimed to release calcium and phosphate ions intraorally to help the self-repair process of enamel. A silica-rich surface layer forms through poly-condensation of hydrated silica groups on which precipitation of ions happens which crystallizes over time to form a hydroxyl-carbonate apatite. Although it is used extensively as a desensitizing agent reports also claim that the chemical reactions that promote apatite formation may enhance the remineralization. But there is limited clinical research to ascertain if there is any synergistic effect on combining anti-cariogenic activity of fluoride ions with these remineralization systems.

Direct benefit of the research to the human volunteer:

  • Have better remineralization for initial white spot carious lesions using recent Novamin technology.
  • Gain the other advantages for Novamin technology on the gingival health as well as dental health.
  • Patient will know the proper brushing technique as he would be given instructions about this during the study.
  • Patient will get to know the difference in efficiency of different over-the-counter toothpastes especially those assigned in the investigator's study.

Scientific value and social Benefits:

  • Determine whether the new Novamin technology results are worth and have good efficient remineralization potential or not.
  • Know more conservative mean for repair of demineralized areas in teeth.
  • Have proper data base about difference in over-the-counter toothpastes.

Research question:

Will recent over-the-counter toothpaste (Novamin & Fluoride) be better than regular over-the-counter toothpaste (Sodium Fluoride) in remineralization of white spot lesions in adult patients who are having initial white spot carious lesions?

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Enamel Caries
Intervention  ICMJE Drug: Sensodyne repair and protect
NovaMin & fluoride toothpaste
Other Name: no other names
Study Arms  ICMJE
  • Active Comparator: Sensodyne repair and protect
    NovaMin & fluoride toothpaste
    Intervention: Drug: Sensodyne repair and protect
  • No Intervention: Sensodyne Daily Care Toothpaste 0.315%
    Sodium fluoride toothpaste
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 12, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2019
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients having at least two permanent tooth surfaces having white spot lesions (buccal/facial aspects of incisors, canines or pre-molars).
  • Subjects with orthodontic appliances.
  • Systemically healthy subjects of both genders, between the ages of 18 to 45 years, who were well versed with the use of toothbrush and dentifrice for oral hygiene maintenance, will be considered for the study.

Exclusion Criteria:

  • Presently on desensitizing treatment.
  • Subjects with bridge work that may interfere with evaluation.
  • Medical histories that may compromise study protocol.(including psychiatric and pharmaco-therapeutic problems)
  • Allergies.
  • Systemic conditions which are etiologic/predisposing to dentinal hypersensitivity (Enamel and dentine genetic abnormalities).
  • Eating disorders.
  • Pregnancy or breast feeding.
  • Any other pathology.
  • Known history of allergies to toothpaste contents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03774498
Other Study ID Numbers  ICMJE CEBD-CU-2018-11-22
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mohammed Farag Abd El-Khalek kelany, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Omyma Safwat, Professor Cairo University
PRS Account Cairo University
Verification Date December 2018

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