Reduction of Dentine Hypersensitivity Using 8% Arginine Based Toothpaste and 8% Strontium Acetate Based Toothpaste (DH)

NCT03061383 | Unknown DMC

• 1 other identifier: CEBC-CU-2017-02-16
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, triple-blind, placebo-controlled study. 51 subjects with a confirmed diagnosis of dentin hypersensitivity were randomized to one of three treatments: Arginine based toothpaste, strontium acetate based toothpaste , or placebo. Treatment will be done at baseline then patients will use the toothpaste at home twice per day by using soft bristled tooth brush and the given dentifrice using modified stillmans method as explained by examiner. Standard test stimuli is calibrated short blast of air syringe, will be applied to sensitive dentin surfaces. Subjects recorded the intensity of sensitivity in response to stimulus on a visual analog scale at baseline, and after 1 week, 2 weeks and 3 months.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• reduction of dentin hypersensitivity

  Subjects recorded the intensity of sensitivity in response to stimulus on a visual analog scale

  3 months

Study Arms (3)

8% Arginine based toothpaste

ACTIVE COMPARATOR

The procedure will be performed after scaling in group D1 using 8% arginine based toothpaste (Colgate Pro-relief) . Treatment will be done at baseline then patients will use the toothpaste at home twice per day by using soft bristled tooth brush and the given dentifrice using modified stillmans method as explained by examiner

Other: 8% Arginine based toothpaste

8% Strontium acetate based toothpaste

ACTIVE COMPARATOR

The procedure will be performed after scaling in group D2 using 8% strontium acetate based toothpaste (Sensodyne Rapid Action) . Treatment will be done at baseline then patients will use the toothpaste at home twice per day by using soft bristled tooth brush and the given dentifrice using modified stillmans method as explained by examiner

Other: 8% strontium acetate based toothpaste

tooth past without active ingredient

PLACEBO COMPARATOR

The procedure will be performed after scaling in group D3 control group using placebo . Treatment will be done at baseline then patients will use the toothpaste at home twice per day by using soft bristled tooth brush and the given dentifrice using modified stillmans method as explained by examiner

Other: placebo

Interventions

8% Arginine based toothpaste OTHER

toothpaste

Also known as: Colgate sensitive Pro-relief

8% Arginine based toothpaste

8% strontium acetate based toothpaste OTHER

toothpaste

Also known as: Sensodyne Rapid Action

8% Strontium acetate based toothpaste

placebo OTHER

toothpaste

tooth past without active ingredient

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
• Subjects aged between 18-35 years
• At least three sensitive teeth (buccal /facial) aspect with recession , abrasion, erosion with a score of \>3 on verbal rating scale, ranging from 0-3= no pain/mild pain, 4-6= moderate pain, and 7- 10= severe pain.
• Subjects were required to be available for the duration of the study, and to sign an informed consent form

You may not qualify if:

• Subjects with a history of allergy to any of the drugs or chemicals used in the study.
• Any removable appliance (RPD or orthodontic retainer). Ongoing orthodontic treatment with fixed appliances.
• Presence of any large or defective restorations, cracked enamel or caries on the hypersensitive tooth.
• Pregnancy and lactating mothers.
• Dental pathology causing pain similar to dentin hypersensitivity.
• Patients with any systemic problem or mental or physical disability

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Esraa Abdel Ghaffar Ahmed Ali

Madīnat an Naşr, Egypt

Location

Related Publications (1)

• Pinto SC, Bandeca MC, Pinheiro MC, Cavassim R, Tonetto MR, Borges AH, Sampaio JE. Preventive effect of a high fluoride toothpaste and arginine-carbonate toothpaste on dentinal tubules exposure followed by acid challenge: a dentine permeability evaluation. BMC Res Notes. 2014 Jun 24;7:385. doi: 10.1186/1756-0500-7-385.

  PMID: 24958423 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• mohamed adel ezzat khairy, PHD

  Professor of Conservative Dentistry, Faculty of Oral and Dental Medicine, Cairo University

  STUDY DIRECTOR

• Maha abdel salam El-baz, PHD

  Lecturer of Conservative Dentistry, Faculty of Oral and Dental Medicine, Cairo University

  STUDY CHAIR

Central Study Contacts

esraa abdel ghaffar ahmed ali, master

CONTACT

01020614170; ososdent@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: It will be a triple blinded study so that the participant, the researcher and the data analysis will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reduction of dentine hypersensitivity using 8% Arginine based toothpaste and 8% Strontium acetate based toothpaste: Randomized Controlled clinical trial

Model Details: Participants will be tested in this study having at least 3 sensitive sound teeth. Participants will be divided into 3 groups, according to the type of desensitizing agents (D); D1 treatment using 8% arginine based toothpaste (Colgate Pro-relief), D2 treatment using 8% strontium acetate based toothpaste (Sensodyne Rapid Action) and D3 control group using placebo (gel without any active ingredient).

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 23, 2017
• Study Start: March 3, 2017
• Primary Completion: October 3, 2018
• Study Completion: November 30, 2018
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)