Effect of Different Over-the-counter Toothpastes on Enamel Remineralization

NCT03774498 | Unknown

• 1 other identifier: CEBD-CU-2018-11-22
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Enamel Caries

Outcome Measures

Primary Outcomes (1)

• Enamel remineralization

  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.

  8 weeks

Study Arms (2)

Sensodyne repair and protect

ACTIVE COMPARATOR

NovaMin \& fluoride toothpaste

Drug: Sensodyne repair and protect

Sensodyne Daily Care Toothpaste 0.315%

NO INTERVENTION

Sodium fluoride toothpaste

Interventions

Sensodyne repair and protect DRUG

NovaMin \& fluoride toothpaste

Also known as: no other names

Sensodyne repair and protect

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Omyma Safwat, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohammed F. Abd El-Khalek, Dentist

CONTACT

01101000457; mohammed.farag@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 13, 2018
• Study Start: January 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 13, 2018

Record last verified: 2018-12