NCT03656432

Brief Summary

Effect of CPP-ACP pastes with/without Fluoride on White spot lesion progression, salivary pH and fluoride release in high caries risk Patients, over 3 month period using VistaCam, Digital pH meter and Selective ion electrode.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2018

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

August 30, 2018

Last Update Submit

September 4, 2018

Conditions

Caries

Keywords

CPP-ACP pastesCPP_ACPFFluoride releaseearly carious lesion

Outcome Measures

Primary Outcomes (1)

  • White Spot Lesion (WSL) progression

    The researcher will inspect the development of any new WSLs in the oral cavity in the clinic of Conservative Dentistry Department Cairo University. The software quantifies the green and red fluorescent light on a scale from 0 to 3 as a ratio of red to green, showing the areas with a higher than healthy tooth ratio.

    (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.

Secondary Outcomes (2)

  • unstimulated Salivary pH change

    (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.

  • stimulated Fluoride Release

    For the WSLs assessment, (T1) baseline before application, (T2) 1 month and (T3) 3 months

Study Arms (3)

CPP-ACP paste

EXPERIMENTAL

MI Paste represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.

Drug: CPP-ACP paste

CPP-ACP containing fluoride

EXPERIMENTAL

MI paste plus contains fluoride 0.2% (900 ppm) that is very similar to the amount of fluoride in the toothpaste binds to the tooth surfaces and plaque and provides biocompatible calcium, phosphate and fluoride in a localized way. So, it provides all the ions needed to build fluorapatite crystals that are more resistant to the acid attack compared to hydroxyapatite

Drug: CPP-ACP paste

toothpaste contains fluoride

ACTIVE COMPARATOR

Fluoridated Toothpaste are the most significant and worldwide spread forms of caries control used globally as the greater acceptability of toothpaste makes its regular use more likely, thereby improving effectiveness

Drug: CPP-ACP paste

Interventions

CPP-ACP pasteDRUG

The complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.

Also known as: CPP-ACP containing fluoride paste
CPP-ACP containing fluorideCPP-ACP pastetoothpaste contains fluoride

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age range from 17-30 years
  • Males or females
  • High caries risk patients defined according to American Dental Association (ADA)
  • Systematically healthy
  • Not taking any medication interfering with saliva secretion
  • Co-operative patients approving to participate in the trial
  • signed informed consent

You may not qualify if:

  • Patients younger than 17 years old or older than 30 years old.
  • Disabilities
  • Subjects suffering from any medical or systematic disease
  • Smokers
  • Pregnant females
  • Allergy to milk derivatives.
  • using any other agents containing fluoride
  • presence of untreated caries lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Poureslami H, Hoseinifar R, Khazaeli P, Hoseinifar R, Sharifi H, Poureslami P. Changes in the Concentration of Ions in Saliva and Dental Plaque after Application of CPP-ACP with and without Fluoride among 6-9 Year Old Children. J Dent Biomater. 2017 Mar;4(1):361-366.

    PMID: 28959766BACKGROUND

  • Sinfiteli PP, Coutinho TCL, Oliveira PRA, Vasques WF, Azevedo LM, Pereira AMB, Tostes MA. Effect of fluoride dentifrice and casein phosphopeptide-amorphous calcium phosphate cream with and without fluoride in preventing enamel demineralization in a pH cyclic study. J Appl Oral Sci. 2017 Nov-Dec;25(6):604-611. doi: 10.1590/1678-7757-2016-0559.

    PMID: 29211281BACKGROUND

  • Heshmat H, Banava S, Mohammadi E, Kharazifard MJ, Mojtahedzadeh F. The effect of recommending a CPP-ACPF product on salivary and plaque pH levels in orthodontic patients: a randomized cross-over clinical trial. Acta Odontol Scand. 2014 Nov;72(8):903-7. doi: 10.3109/00016357.2014.920515. Epub 2014 May 26.

    PMID: 24856191BACKGROUND

  • Ebrahimi M, Mehrabkhani M, Ahrari F, Parisay I, Jahantigh M. The effects of three remineralizing agents on regression of white spot lesions in children: A two-week, single-blind, randomized clinical trial. J Clin Exp Dent. 2017 May 1;9(5):e641-e648. doi: 10.4317/jced.53582. eCollection 2017 May.

    PMID: 28512540BACKGROUND

  • Tassery H, Levallois B, Terrer E, Manton DJ, Otsuki M, Koubi S, Gugnani N, Panayotov I, Jacquot B, Cuisinier F, Rechmann P. Use of new minimum intervention dentistry technologies in caries management. Aust Dent J. 2013 Jun;58 Suppl 1:40-59. doi: 10.1111/adj.12049.

    PMID: 23721337BACKGROUND

Related Links

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Mohamed R Farid, PhD

    Professor of Conservative Dentistry, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Doaa G Ashour, Master

CONTACT

01006512932Doaa.Gamal@dentistry.cu.edu.eg

Rania S Mosallam, PhD

CONTACT

01004222674rania.mosallam@hoymail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and PHD student at Conservative Dentistry Department

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 4, 2018

Study Start

October 1, 2018

Primary Completion

April 1, 2020

Study Completion

June 1, 2020

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share