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Effectiveness of Nanohydroxyapetite Paste on Reducing Dentin Hypersensitivity

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: NCT02936830
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : March 11, 2020
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)
Actual Enrollment : 63 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
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Placebo Comparator: Control
21 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
21 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
21 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT02936830

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Saudi Arabia
Riyadh colleges of dentistry and pharmacy olaya campus
Riyadh, ArRiyadh, Saudi Arabia, 11681
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
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Principal Investigator: Dalia N AlHarith Riyadh Colleges of Dentistry and Pharmacy
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Responsible Party: Dalia Nayil Alharith, Post-graduate student, Riyadh Colleges of Dentistry and Pharmacy Identifier: NCT02936830    
Other Study ID Numbers: FPGRP/43533002/71
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Sodium Fluoride
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Cryoprotective Agents