NCT04896294

Brief Summary

This will be a double-blind, randomized, three-arm parallel groups study of the effect of toothpastes containing Ca-hydroxyapatite (HAP), Mg-Zn-hydroxyapatite (Zn-Mg-HAP), or fluoroapatite (FAP). The aim of the study is to compare the effect of toothpastes containing Ca-hydroxyapatite (HAP), fluoroapatite (FAP), and Mg-Zn-hydroxyapatite (Mg-Zn-HAP) on dentin hypersensitivity associated with dental abrasion. Materials and methods. Thirty consent patients aged 35-45 with dentin hypersensitivity associated with abrasion will be recruited for the study. The study will have 2 phases: preparatory phase (recruitment of the patients, standardization of their oral hygiene protocols, wash-out period, calibration of the researchers and training) and the main part (double-blind, randomized, parallel groups study of toothpastes effect). Patients will be randomly divided into 3 groups (group 1 - toothpastes with Ca-HAP, group 2 - toothpastes with Zn-Mg-HAP, group 3 - toothpastes with FAP). Clinical examination will be performed at the baseline, after 2 and 4 weeks, and will include patient's interview, oral hygiene level assessment (OHI-S), and dentin sensitivity testing (Shiff's index). The null hypothesis is that there will be no statistically significant differences in dentin sensitivity level between the study groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2021

Completed
Last Updated

October 1, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 12, 2021

Last Update Submit

September 30, 2021

Conditions

Dentin Hypersensitivity

Keywords

dentin sensitivitytooth abrasionCa-hydroxyapatitefluoroapatiteMg-Zn-hydroxyapatite

Outcome Measures

Primary Outcomes (1)

  • change in dentin hypersensitivity score according to Shiff's index

    Air from air/water syringe is applied perpendicular to the cervical areas of the tooth from a distance of 1 cm for a second. Enamel sensitivity is estimated in accordance with the following criteria: 0 - no reaction, 1. \- discomfort but the patient does not insist on stopping the test, 2. \- discomfort, accompanied by a request to discontinue the test, 3. \- severe pain reaction with pronounced motor reactions aimed at the immediate termination of the test.

    4 weeks after the baseline

Study Arms (3)

Group 1 - HAP-containing toothpaste

ACTIVE COMPARATOR

The use of HAP-containing toothpaste twice daily (using standardised toothbrushing technique) for 4 weeks. Toothpaste composition: Aqua, Sorbitol, Hydrated Silica, Glycerin, Hydroxyapatite, Cellulose Gum, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocoyl Taurate, Aroma, Xanthan Gum, Stevia Rebaudiana Extract, Anethole, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Eucalyptol, o-Cymen-5-ol, Citric Acid, Vitis Vinifera (Grape) Seed Extract, Tannase, Thymol, Limonene. Fluoride free.

Combination Product: Hygienic procedure (toothbrushing using HAP-containing toothpaste)

Group 2 - Zn Mg HAP-containing toothpaste

EXPERIMENTAL

The use of Zn Mg HAP-containing toothpaste twice daily (using standardised toothbrushing technique) for 4 weeks. Toothpaste composition: Aqua, Sorbitol, Hydrated Silica, Glycerin, Zn-Mg-hydroxyapatite, Cellulose Gum, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocoyl Taurate, Aroma, Xanthan Gum, Stevia Rebaudiana Extract, Anethole, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Eucalyptol, o-Cymen-5-ol, Citric Acid, Vitis Vinifera (Grape) Seed Extract, Tannase, Thymol, Limonene. Fluoride free.

Combination Product: Hygienic procedure (toothbrushing using Zn Mg HAP-containing)

Group 3 - FAP-containing toothpaste

EXPERIMENTAL

The use of FAP-containing toothpaste twice daily (using standardised toothbrushing technique) for 4 weeks. Toothpaste composition: Aqua, Sorbitol, Hydrated Silica, Glycerin, Fluorapatite, Cellulose Gum, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocoyl Taurate, Aroma, Xanthan Gum, Stevia Rebaudiana Extract, Anethole, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Eucalyptol, o-Cymen-5-ol, Citric Acid, Vitis Vinifera (Grape) Seed Extract, Tannase, Thymol, Limonene.

Combination Product: Hygienic procedure (toothbrushing using FAP-containing toothpaste)

Interventions

Hygienic procedure (toothbrushing using HAP-containing toothpaste)COMBINATION_PRODUCT

Toothbrushing using standardised technique and pear-sized amount of HAP-containing toothpaste twice daily for 1 month.

Group 1 - HAP-containing toothpaste
Hygienic procedure (toothbrushing using Zn Mg HAP-containing)COMBINATION_PRODUCT

Toothbrushing using standardised technique and pear-sized amount of Zn Mg HAP-containing toothpaste twice daily for 1 month.

Group 2 - Zn Mg HAP-containing toothpaste
Hygienic procedure (toothbrushing using FAP-containing toothpaste)COMBINATION_PRODUCT

Toothbrushing using standardised technique and pear-sized amount of FAP-containing toothpaste twice daily for 1 month.

Group 3 - FAP-containing toothpaste

Eligibility Criteria

Age35 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged between 35 and 45 years
  • signed an approved Informed Consent Form, authorizing the participation in the trial and the use of the results of the trial for educational purposes and for the publication
  • the diagnosis of dentin hypersensitivity stated clinically
  • a premolar or first molar with an abrasive cervical defect of at least 1 millimeter, and not deeper than 1.5 millimeter, as measured by placing a periodontal probe into the deepest part of the cervical lesion; no mesial, distal or buccal restorations (to avoid confounding hypersensitivity)
  • a hypersensitivity score of 2 or higher on the Shiff scale with standardized air-blast stimulation
  • no other tooth in the same quadrant exhibiting hypersensitivity

You may not qualify if:

  • medical and pharmacotherapeutic histories that may compromise the protocol (pregnancy or breastfeeding, allergies to toothpastes ingredients, eating disorders)
  • systemic conditions that are etiologic to dentin hypersensitivity (e.g., chronic acid regurgitation)
  • excessive dietary or environmental exposure to acids
  • periodontal surgery in the preceding 3 months
  • orthodontic appliance treatment within previous 3 months
  • teeth or supporting structures with any other painful pathology or defects
  • teeth restored in the preceding 3 months
  • abutment teeth for fixed or removable prostheses
  • extensively restored teeth and those with restorations extending into the test area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Dentistry of Sechenov University

Moscow, 121059, Russia

Location

Related Publications (5)

  • Makeeva IM, Polyakova MA, Doroshina VY, Turkina AY, Babina KS, Arakelyan MG. [Comparative effectiveness of therapeutic toothpastes with fluoride and hydroxyapatite]. Stomatologiia (Mosk). 2018;97(5):34-40. doi: 10.17116/stomat20189705134. Russian.

    PMID: 30346419BACKGROUND

  • Makeeva IM, Budaychieva ZS, Polyakova MA, Margaryan EG, Novozhilova NE, Musiyev AA. [Special aspects of individual oral hygiene in patients with I class gingival recession]. Stomatologiia (Mosk). 2019;98(4):25-28. doi: 10.17116/stomat20199804125. Russian.

    PMID: 31513144BACKGROUND

  • Sokhova IA, Doroshina VY, Polyakova MA, Margaryan EG. [Comparative assessment of the effectiveness of toothpastes to reduce hyperesthesia in inflammatory periodontal diseases]. Stomatologiia (Mosk). 2020;99(1):27-32. doi: 10.17116/stomat20209901127. Russian.

    PMID: 32125298BACKGROUND

  • Makeeva IM, Polyakova MA, Doroshina VY, Sokhova IA, Arakelyan MG, Makeeva MK. [Efficiency of paste and suspension with nano-hydroxyapatite on the sensitivity of teeth with gingival recession]. Stomatologiia (Mosk). 2018;97(4):23-27. doi: 10.17116/stomat20189704123. Russian.

    PMID: 30199063BACKGROUND

  • Polyakova MA, Arakelyan MG, Babina KS, Margaryan EG, Sokhova IA, Doroshina VY, Novozhilova NE. Qualitative and Quantitative Assessment of Remineralizing Effect of Prophylactic Toothpaste Promoting Brushite Formation: A Randomized Clinical Trial. J Int Soc Prev Community Dent. 2020 May 7;10(3):359-367. doi: 10.4103/jispcd.JISPCD_493_19. eCollection 2020 May-Jun.

    PMID: 32802784BACKGROUND

MeSH Terms

Conditions

Dentin SensitivityTooth Abrasion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth Wear

Study Officials

  • Maria Polyakova, PhD

    Sechenov University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 21, 2021

Study Start

April 24, 2021

Primary Completion

June 21, 2021

Study Completion

July 19, 2021

Last Updated

October 1, 2021

Record last verified: 2021-05

Locations

RU(1)