The aim of this study was to investigate the effect of Casein Phosphopeptide -Amorphous Calcium Phosphate with Fluoride paste on plaque and salivary pH levels in fixed orthodontic patients. In this crossover randomized clinical trial, performed in a private practice, 30 patients who have undergone fixed orthodontic treatment for at least 3 and at most 12 months, free from systemic disorders, not using any medication or mouthwash and have maintained permanent first molars were included in this study. The initial plaque and salivary pH is recorded and then patients are randomly assigned to 2 groups, where in the first group patients are instructed to use a Casein Phosphopeptide -Amorphous Calcium Phosphate/Fluoride paste and a placebo in the other. The pH levels are recorded after one month, where after patients experience a one month washout period. The pH is recorded once again and the patients are given the alternative paste respectively. The final pH levels are recorded after one month of using the alternate paste. In this study, the clinician, researcher and patient are blinded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903244185N1
Registration date:2011-07-12, 1390/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-12, 1390/04/21
Registrant information
Name
Haleh Heshmat
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 8808 5500
Email address
mojzad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of pH changes in orthodontic patients using Casein Phosphopeptide -Amorphous Calcium Phosphate with Fluoride paste
Public title
Investigating the effect of Casein Phosphopeptide -Amorphous Calcium Phosphate with Fluoride on caries prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Patients receiving fixed orthodontic treatment and over 12 years of age. Between 3 and 12 months of their orthodontic treatment should have commenced.
Exclusion criteria: Taking medications; systemic diseases; pregnancy; loss/missing of first permanent molars; using mouthwashes.
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Dentistry Ethics comittee, Tehran Islamic Azad University
Street address
No.4 - Neyestan 10 - Pasdaran Street
City
Tehran
Postal code
Approval date
2011-03-13, 1389/12/22
Ethics committee reference number
د/129/پ
Health conditions studied
1
Description of health condition studied
Caries limited to enamel
ICD-10 code
K02.0
ICD-10 code description
White spots (Initial caries)
Primary outcomes
1
Description
Salivary pH
Timepoint
Before and after each paste use. A total of 4 measures with one month intervals
Method of measurement
pH test strips
2
Description
Plaque pH
Timepoint
Before and after each paste use. A total of 4 measures with one month intervals
Method of measurement
pH test strips
Secondary outcomes
empty
Intervention groups
1
Description
As a crossover study, patients in the first group receive the medication - MI paste plus - containing casein phosphopeptide - amorphous calcium phosphate and Fluoride. A pea-sized amount of the paste is applied to the teeth each night after routine brushing. This regimen is continued for one month
Category
Treatment - Drugs
2
Description
As a crossover study, patients in the second group receive the placebo paste first. The placebo is also a paste but devoid of any active ingredient. A pea-sized amount of the paste is applied to the teeth each night after routine brushing. This regimen is continued for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private practice
Full name of responsible person
Faramarz Mojtahedzadeh DMD, MS
Street address
No. 3, 8th street, Gandhi Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Haleh Heshmat
Street address
2D, Building 12, Sina Complex, Iranzamin St, Phase 1, Shahrake Qarb
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Dentistry, Tehran Azad University
Full name of responsible person
Haleh Heshmat DMD,MS
Position
Specialist in Restorative Dentistry/ Assistant Professor
Other areas of specialty/work
Street address
2d, Building 12, Sina complex, Phase 1, Shahrake Qarb
City
Tehran
Postal code
Phone
+98 21 8808 5500
Fax
Email
h_heshmat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Tehran Azad University
Full name of responsible person
Haleh Heshmat DMD, MS
Position
Specialist in Restorative Dentistry/ Assistant Professor
Other areas of specialty/work
Street address
2D, Building 12, Sina Complex, Phase 1, Shahrake Qarb
City
Tehran
Postal code
Phone
+98 21 8808 5500
Fax
+98 21 8808 5500
Email
h_heshmat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Faramarz Mojtahedzadeh DMD,MS
Position
Assisstant Professor, (DMD, MS) Orthodontist
Other areas of specialty/work
Street address
2D, Building 12, Sina Complex, Phase 1, ShahrakeQarb
City
Tehran
Postal code
1465896473
Phone
+98 21 8808 5500
Fax
Email
mojzad@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)