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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

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.

Condition or disease Intervention/treatment Phase
Dentin Hypersensitivity Drug: 5% Sodium Fluoride Varnish Drug: 15% Nanohydroxyapetite paste Drug: Glycerol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effectiveness of Nano-hydroxyapetite Care Paste in Reducing Dentinhypersenstitivity: A Double Blind Randomized Control Trial
Study Start Date : October 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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
Drug: Glycerol
Glycerol with water in a 1: 1 ratio
Other Name: glycerol water mixture

Active Comparator: Fluoride group
20 individuals with dentin hypersensitivity will receive 5% Sodium Fluoride varnish applied on the sensitive area by the dentist
Drug: 5% Sodium Fluoride Varnish
5% sodium fluoride varnish applied on the dentin by the dentist
Other Name: Duraphat

Experimental: Nanohydroxyapetite
20 individuals with dentin hypersensitivity will receive 15% nanohydroxyapetite paste applied on the sensitive area by the dentist
Drug: 15% Nanohydroxyapetite paste
15% nanohydoxyapetite paste without potassium nitrate or fluoride applied on the dentin by the dentist
Other Name: Nanohydroxyapetite paste




Primary Outcome Measures :
  1. Sensitivity measured by a visual analog scale [ Time Frame: One month ]
    Dentin sensitivity measured by giving the patient a visual analog scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02936830


Contacts
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Contact: Hezekiah A Mosadomi, DMD 0096612931177 ext 132 prof.mosadomi@riyadh.edu.sa

Locations
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Saudi Arabia
Riyadh colleges of dentistry and pharmacy olaya campus Recruiting
Riyadh, ArRiyadh, Saudi Arabia, 11681
Contact: Dalia N Alharith    0551303333    Alsharifadalia.alharith@student.riyadh.edu.sa   
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
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Principal Investigator: Dalia N AlHarith Riyadh Colleges of Dentistry and Pharmacy

Publications:
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Responsible Party: Dalia Nayil Alharith, Post-graduate student, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT02936830     History of Changes
Other Study ID Numbers: FPGRP/43533002/71
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sodium Fluoride
Listerine
Hypersensitivity
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Glycerol
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Cryoprotective Agents