The effect of casein phosphopeptide - amorphous calcium phosphate on saliva
| ISRCTN | ISRCTN17509082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17509082 |
| Secondary identifying numbers | 2090 |
- Submission date
- 05/11/2022
- Registration date
- 22/11/2022
- Last edited
- 12/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Dental caries (tooth decay) has multiple causes, including dental plaque, which can be controlled with a mixture of different strategies. Increasing the secretion of saliva increases the proportion of calcium and phosphate ions dissolved, reducing demineralization and promoting remineralization, which in turn prevents caries. Casein phosphopeptide - amorphous calcium phosphate (CPP-ACP) has been demonstrated to have anticariogenic activity. Due to the lack of any studies on the effect of pastes containing this substance on saliva, the aim of this study is to investigate its effectiveness in increasing the proportion of calcium in saliva and its impact on the pH and salivary flow rate, and the tooth remineralization process in children.
Who can participate?
Children aged 6-8 years old
What does the study involve?
Participants will be asked to apply GC tooth mousse (containing CPP-ACP) or placebo (dummy) mousse in order to study the changes in saliva pH, salivary flow rate and calcium concentration in saliva.
What are the possible benefits and risks of participating?
The GC tooth mousse may help with the remineralization process. There are no risks involved.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
September 2021 to April 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Muaaz Alkhouli, muaaz.alkhouli@outlook.com
Contact information
Principal Investigator
Faculty of Dental Medicine
2nd Floor
Pediatric Dentistry Department
Mazzeh Street
Damascus
0000
Syria
 ORCID ID |
0000-0003-0220-3859 |
|---|---|
| Phone | +963 (0)966133383 |
| muaaz.alkhouli@outlook.com |
Scientific
Faculty of Dental Medicine
2nd Floor
Pediatric Dentistry department
Mazzeh Street
Damascus
0000
Syria
| Phone | +963 (0)966956853 |
|---|---|
| mdashash@yahoo.com |
Study information
| Study design | Interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of casein phosphopeptide - amorphous calcium phosphate on salivary flow rate, salivary pH and salivary calcium concentration in children |
| Study acronym | CPP-ACP |
| Study hypothesis | 1. Casein phosphopeptide - amorphous calcium phosphate (CPP-ACP) causes an increased salivary flow rate compared with a placebo 2. CPP-ACP results in a higher pH of saliva compared with a placebo 3. CPP-ACP increases the calcium concentration of saliva more than the placebo does |
| Ethics approval(s) | Approved 17/09/2021, ethics scientific committee at Damascus University (Mazzeh Street, Damascus, Syria; +963 (0)9933490577; drsalloum74@hotmail.com), ref: 2090 |
| Condition | Remineralization capacity of CPP-ACP |
| Intervention | Participants will be allocated equally into two groups: Group 1 (intervention) receive GC Tooth Mousse (CPP-ACP) and Group 2 (control) receive a placebo mousse. A random allocation list will be carried out using the website https://www.randomlists.com/, all of the participants will be numbered from 1 - 50 in order to allocate them randomly into the two study groups. Saliva samples are taken from the participants before the application, after the application directly, after half an hour and after an hour. the pH of the collected samples, salivary flow rate and calcium concentration are tested. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), GC tooth mousse |
| Primary outcome measure | Measured at T0: before the application (baseline); T1: directly after the application ; T2: after half an hour; T3: after 1 hour: 1. pH of saliva measured using pH test strips (Whatman® Panpeha™ pH indicator strips) 2. Salivary flow rate measured by calculating the amount of saliva which will be collected in tubes and dividing it into five to see the amount of saliva secreted per minute (ml/d) |
| Secondary outcome measures | Calcium concentration of saliva measured using Calein as an indicator, ethylenediaminetetra-acetate (EDTA) as a Ca-complexing agent, and a standard Ca solution to set up the calibration series; measured at T0: before the application (baseline); T1: directly after the application ; T2: after half an hour; T3: after 1 hour. |
| Overall study start date | 17/09/2021 |
| Overall study end date | 04/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Participant inclusion criteria | 1. Good oral hygiene 2. Participants not be taking antibiotics or any kind of medications that can affect the flow rate of saliva 3. Does not suffer from an allergy to milk protein confirmed or suspected and/or the presence of the sensitivity of benzoate (preservative) |
| Participant exclusion criteria | 1. Taking antibiotics or drugs that may affect the salivary flow rate 2. The existence of diseases that may affect the flow rate of saliva or a combination such as diabetes 3. Sensitivity to milk protein confirmed or suspected and/or the presence of the sensitivity of benzoate (preservative) |
| Recruitment start date | 01/12/2021 |
| Recruitment end date | 02/03/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
30621
Syria
Sponsor information
University/education
Mazzeh Street
Damascus
30621
Syria
| Phone | +963 (11) 339 23223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 04/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The original data, along with the codebook and analysis scripts, will be stored at the Damascus University repository. The data will consist of csv sheets with the data of the patients and R analysis scripts. The dataset will be called dataset and the dataset generated by the research, including also preprints and technical reports, will be called dataverse. The dataverse corresponding to this investigation will receive a digital object identifier (DOI). The citation has seven components. Five are human-readable: the author(s), title, year, data repository (or distributor), and version number. Two components are machine-readable: the DOI and the universal numeric fingerprint (UNF). The data generated will be de-identified using R's randomizeR package, removing all personal information. The naming convention for the archives will be date in yyyymmdd-version-identifier.extension format. The use of spaces will be avoided, being replaced by -. The original anonymized data will be published in the Mendeley data repository with restricted access once the data cleaning and exploratory analysis stage is completed. The data will be made public at the time of sending the final report to a peer-reviewed journal, with its DOI corresponding to the data associated with the research. The data will be embargoed until the final report is accepted, at which time it will become publicly available. No access restrictions will be applied to the data once the final project report has been accepted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Salivary pH and salivary flow results | 11/04/2023 | 12/04/2023 | Yes | No |
Editorial Notes
12/04/2023: Publication reference added.
14/02/2023: The study setting has been changed from ‘Other’.
22/11/2022: Trial's existence confirmed by the ethics scientific committee at Damascus University.
