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Effectiveness of Nanohydroxyapetite Paste on Reducing Dentin Hypersensitivity

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ClinicalTrials.gov Identifier: NCT02936830
Recruitment Status : Unknown
Verified October 2016 by Dalia Nayil Alharith, Riyadh Colleges of Dentistry and Pharmacy.
Recruitment status was:  Recruiting
First Posted : October 18, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Dalia Nayil Alharith, Riyadh Colleges of Dentistry and Pharmacy

Tracking Information
First Submitted Date  ICMJE October 16, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date October 19, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Sensitivity measured by a visual analog scale [ Time Frame: One month ]
Dentin sensitivity measured by giving the patient a visual analog scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02936830 on ClinicalTrials.gov Archive Site
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 Effectiveness of Nanohydroxyapetite Paste on Reducing Dentin Hypersensitivity
Official Title  ICMJE Effectiveness of Nano-hydroxyapetite Care Paste in Reducing Dentinhypersenstitivity: A Double Blind Randomized Control Trial
Brief Summary The aim of this study is to compare the efficacy of dentine hypersensitivity reduction using in office paste formula containing nanoHydroxyapatite with the commercially available fluoride (duraphat) and a placebo in treating hypersensitivity in a single visit.
Detailed Description

Following the approval of the Research Ethics Committee of Riyadh college of Dentistry and Pharmacy (The Institutional Review Board), a randomized double blind single treatment controlled clinical trial will be carried out on 60 patients (-- males and -- females) between the age group of 18 to 45 years, visiting the out-patient clinics of Riyadh Colleges of Dentistry and Pharmacy during the period between October and December.

The protocols for the study will be developed as per the guidelines for the design and conduct of clinical trials on dentinal hypersensitivity and in accordance with the Declaration of Helsinki and Guidelines for Good Clinical Practice. Prior to the start of the study patients will be given both verbal and written information about the process and an appropriate signed informed consent form will be obtained.

Only subjects demonstrating two hypersensitive teeth that satisfied the tactile and airblast hypersensitivity enrolment criteria, qualified to participate in the study. Qualified subjects will be randomly defined to one of the three study groups in order to have 20 subjects per treatment group:

  • Study 1: nanoXIM care paste, fluoride-free (test group)
  • Study 2: fluoride paste
  • Study 3: placebo group (positive control group).

Subjects selected will undergo thorough clinical examination, followed by oral prophylaxis, oral hygiene instructions and dietary counseling. After the teeth isolation with cotton rolls, changes in the dentin sensitivity to tactile (dental explorer), thermal stimuli (drops of melted ice) and air stimuli (blast from dental syringe) will be evaluated. Following application of the stimuli, responses will be evaluated and assessed by the Visual Analog Scale (VAS). The survey form will be completed by the examiner to have a baseline prior to paste application in the first visit. The survey contains five questions, rated on a 10-point scale, assessing:

  1. Degree of pain.
  2. Duration of pain.
  3. Intensity of pain.
  4. Tolerability of pain.
  5. Description of pain.

Data Analysis

The study patients will be randomly assigned into 3 groups (N, F and P) equal groups of 20. The randomization process will be made using a computer-generated random table. Excel software (Micro- soft) will be used for randomization. The pastes used on the study labeled N, F and P respectively, will be completely wrapped not allowing the pastes applicant or any other member of the research team to know what test paste will be applied on the patients. The patients will be blinded by not letting them know which agents will be applied. The chief investigator, the first author in this study, will coordinate the entire trial and recruited the various operators for the same.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Dentin Hypersensitivity
Intervention  ICMJE
  • Drug: 5% Sodium Fluoride Varnish
    5% sodium fluoride varnish applied on the dentin by the dentist
    Other Name: Duraphat
  • Drug: 15% Nanohydroxyapetite paste
    15% nanohydoxyapetite paste without potassium nitrate or fluoride applied on the dentin by the dentist
    Other Name: Nanohydroxyapetite paste
  • Drug: Glycerol
    Glycerol with water in a 1: 1 ratio
    Other Name: glycerol water mixture
Study Arms  ICMJE
  • Placebo Comparator: Control
    20 individuals with dentin hypersensitivity will receive a placebo solution of glycerol diluted in water in a 1:1 concentration applied on the sensitive area by the dentist
    Intervention: Drug: Glycerol
  • Active Comparator: Fluoride group
    20 individuals with dentin hypersensitivity will receive 5% Sodium Fluoride varnish applied on the sensitive area by the dentist
    Intervention: Drug: 5% Sodium Fluoride Varnish
  • Experimental: Nanohydroxyapetite
    20 individuals with dentin hypersensitivity will receive 15% nanohydroxyapetite paste applied on the sensitive area by the dentist
    Intervention: Drug: 15% Nanohydroxyapetite paste
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hypersensitive areas on facial surfaces of the teeth (incisors, canines, premolars, and first molars with exposed cervical dentin) with at least two teeth scoring "pain (scale stimuli test, scores 2 and 3)" during application of stimulus (airblast and tactile sensitivity test)
  • Good periodontal health (no probing depth > 4 mm) with no other conditions that might explain their apparent dentin hypersensitivity
  • Good overall physical health
  • Age between 18 and 45 years
  • Provision of written informed consent
  • Patient willing to participate in the study

Exclusion Criteria:

  • Chipped teeth
  • Defective restorations
  • Fractured undisplaced canines
  • Deep dental caries
  • Deep periodontal pockets
  • Orthodontic appliances
  • Dentures or fixed dental prostheses that would interfere with the evaluation of hypersensitivity
  • Periodontal surgery within the previous 6 months
  • Ongoing treatment with antibiotics and/or anti- inflammatory drugs past 3 months
  • Ongoing treatment for tooth hypersensitivity
  • Pregnancy or lactation
  • Smokers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02936830
Other Study ID Numbers  ICMJE FPGRP/43533002/71
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dalia Nayil Alharith, Riyadh Colleges of Dentistry and Pharmacy
Study Sponsor  ICMJE Riyadh Colleges of Dentistry and Pharmacy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dalia N AlHarith Riyadh Colleges of Dentistry and Pharmacy
PRS Account Riyadh Colleges of Dentistry and Pharmacy
Verification Date October 2016

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