Effectiveness of Nanohydroxyapetite Paste on Reducing Dentin Hypersensitivity

NCT02936830 | Completed Phase 4 DMC

• 1 other identifier: FPGRP/43533002/71
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Sensitivity measured by a visual analog scale

  Dentin sensitivity measured by giving the patient a visual analog scale

  One month

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Fluoride group

ACTIVE COMPARATOR

21 individuals with dentin hypersensitivity will receive 5% Sodium Fluoride varnish applied on the sensitive area by the dentist

Drug: 5% Sodium Fluoride Varnish

Nanohydroxyapetite

EXPERIMENTAL

21 individuals with dentin hypersensitivity will receive 15% nanohydroxyapetite paste applied on the sensitive area by the dentist

Drug: 15% Nanohydroxyapetite paste

Interventions

5% Sodium Fluoride Varnish DRUG

5% sodium fluoride varnish applied on the dentin by the dentist

Also known as: Duraphat

Fluoride group

15% Nanohydroxyapetite paste DRUG

15% nanohydoxyapetite paste without potassium nitrate or fluoride applied on the dentin by the dentist

Also known as: Nanohydroxyapetite paste

Nanohydroxyapetite

Glycerol DRUG

Glycerol with water in a 1: 1 ratio

Also known as: glycerol water mixture

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh colleges of dentistry and pharmacy olaya campus

Riyadh, ArRiyadh, 11681, Saudi Arabia

Location

Related Publications (4)

• 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.

  PMID: 27217637 BACKGROUND

• 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.

  PMID: 27128158 BACKGROUND

• 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.

  PMID: 26919080 BACKGROUND

• 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.

  PMID: 26464553 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

sodium fluoride topical preparation; Glycerol

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Dalia N AlHarith

  Riyadh Colleges of Dentistry and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate student

Study Record Dates

• First Submitted: October 16, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)