Effectiveness of Nanohydroxyapetite Paste on Reducing Dentin Hypersensitivity
Primary Purpose
Dentin Hypersensitivity
Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
5% Sodium Fluoride Varnish
15% Nanohydroxyapetite paste
Glycerol
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Hypersensitivity
Eligibility 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
Sites / Locations
- Riyadh colleges of dentistry and pharmacy olaya campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Control
Fluoride group
Nanohydroxyapetite
Arm Description
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
21 individuals with dentin hypersensitivity will receive 5% Sodium Fluoride varnish applied on the sensitive area by the dentist
21 individuals with dentin hypersensitivity will receive 15% nanohydroxyapetite paste applied on the sensitive area by the dentist
Outcomes
Primary Outcome Measures
Sensitivity measured by a visual analog scale
Dentin sensitivity measured by giving the patient a visual analog scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02936830
First Posted
October 16, 2016
Last Updated
March 9, 2020
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT02936830
Brief Title
Effectiveness of Nanohydroxyapetite Paste on Reducing Dentin Hypersensitivity
Official Title
Effectiveness of Nano-hydroxyapetite Care Paste in Reducing Dentinhypersenstitivity: A Double Blind Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Degree of pain.
Duration of pain.
Intensity of pain.
Tolerability of pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Fluoride group
Arm Type
Active Comparator
Arm Description
21 individuals with dentin hypersensitivity will receive 5% Sodium Fluoride varnish applied on the sensitive area by the dentist
Arm Title
Nanohydroxyapetite
Arm Type
Experimental
Arm Description
21 individuals with dentin hypersensitivity will receive 15% nanohydroxyapetite paste applied on the sensitive area by the dentist
Intervention Type
Drug
Intervention Name(s)
5% Sodium Fluoride Varnish
Other Intervention Name(s)
Duraphat
Intervention Description
5% sodium fluoride varnish applied on the dentin by the dentist
Intervention Type
Drug
Intervention Name(s)
15% Nanohydroxyapetite paste
Other Intervention Name(s)
Nanohydroxyapetite paste
Intervention Description
15% nanohydoxyapetite paste without potassium nitrate or fluoride applied on the dentin by the dentist
Intervention Type
Drug
Intervention Name(s)
Glycerol
Other Intervention Name(s)
glycerol water mixture
Intervention Description
Glycerol with water in a 1: 1 ratio
Primary Outcome Measure Information:
Title
Sensitivity measured by a visual analog scale
Description
Dentin sensitivity measured by giving the patient a visual analog scale
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalia N AlHarith
Organizational Affiliation
Riyadh Colleges of Dentistry and Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riyadh colleges of dentistry and pharmacy olaya campus
City
Riyadh
State/Province
ArRiyadh
ZIP/Postal Code
11681
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27217637
Citation
Kunam D, Manimaran S, Sampath V, Sekar M. Evaluation of dentinal tubule occlusion and depth of penetration of nano-hydroxyapatite derived from chicken eggshell powder with and without addition of sodium fluoride: An in vitro study. J Conserv Dent. 2016 May-Jun;19(3):239-44. doi: 10.4103/0972-0707.181940.
Results Reference
background
PubMed Identifier
27128158
Citation
Douglas de Oliveira DW, Oliveira ES, Mota AF, Pereira VH, Bastos VO, Gloria JC, Goncalves PF, Flecha OD. Effectiveness of Three Desensitizing Dentifrices on Cervical Dentin Hypersensitivity: A Pilot Clinical Trial. J Int Acad Periodontol. 2016 Apr 8;18(2):57-65.
Results Reference
background
PubMed Identifier
26919080
Citation
Wang L, Magalhaes AC, Francisconi-Dos-Rios LF, Calabria MP, Araujo D, Buzalaf M, Lauris J, Pereira JC. Treatment of Dentin Hypersensitivity Using Nano-Hydroxyapatite Pastes: A Randomized Three-Month Clinical Trial. Oper Dent. 2016 Jul-Aug;41(4):E93-E101. doi: 10.2341/15-145-C. Epub 2016 Feb 26.
Results Reference
background
PubMed Identifier
26464553
Citation
Gopinath NM, John J, Nagappan N, Prabhu S, Kumar ES. Evaluation of Dentifrice Containing Nano-hydroxyapatite for Dentinal Hypersensitivity: A Randomized Controlled Trial. J Int Oral Health. 2015 Aug;7(8):118-22.
Results Reference
background
Learn more about this trial
Effectiveness of Nanohydroxyapetite Paste on Reducing Dentin Hypersensitivity
We'll reach out to this number within 24 hrs