Does laban with probiotics effect the acidity of saliva in individuals with braces?
| ISRCTN | ISRCTN13794257 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13794257 |
| Secondary identifying numbers | TUCDREC/040224/SJambi |
- Submission date
- 28/05/2024
- Registration date
- 30/05/2024
- Last edited
- 30/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to investigate the effect of laban containing probiotics on the acidity of saliva in people who have fixed (glued on) braces on their teeth.
When individuals get braces, this leads to some changes in the mouth, such as the degree of acidity of the saliva in your mouth. Increased acid values in combination with difficulty in cleaning teeth with braces can lead to unsightly enamel demineralization, and in severe cases cavities in the teeth. This is an irreversible process. Laban with probiotics has the potential of normalising the acidity in the mouth, thus reducing the effects of demineralization and cavities.
Who can participate?
Anyone with fixed braces attending the Taibah University dental clinics is welcome to participate.
What does the study involve?
The study involves attending to the dental clinic and you will be asked to either rinse with the laban with probiotics, the laban without probiotics or you will not be asked to rinse with anything. Which of these three categories you will recieve will depend on chance. Also, if you do get to rince, neither the dentist caring for you or yourself will know which laban you are rinsing with. This is important for the integrety of the study.
Then the dentist will do a few measurements:
1. They will dry your lower lip and observe when it gets wet again
2. They will ask you to chew on a piece of tasteless wax gum and spit in a little cup
3. Then they will use the saliva in the cup to measure the amount of saliva in the cup as well as the acidity using two different types of strips.
You will be asked to do this 4 times with adequate rest in between.
What are the possible benefits and risks of participating?
There is no pain or discomfort from participating in the study, and you will be serving the community by participating. There is minimum risk to participating in the study. If you are allergic or intolerent to milk, it is important to let us know, and in this case unfortunately you won't be able to participate in the study for your own safety.
Where is the study run from?
Taibah University College of Dentistry (Saudi Arabia)
When is the study starting and how long is it expected to run for?
January 2024 to February 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Safa Jambi
sjambi@taibahu.edu.sa
Contact information
Public, Scientific, Principal Investigator
5242 Rashid AlSalmi St
Madinah
42319
Saudi Arabia
 ORCID ID |
0000-0002-2658-8215 |
|---|---|
| Phone | +966 555521721 |
| sjambi@taibahu.edu.sa |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Prevention, Efficacy |
| Participant information sheet | https://docs.google.com/forms/d/e/1FAIpQLSd6jGzNWuHpLAHFktBSYHV3ZNSOOjswkjJi6iDjMjTHEMaPvg/viewform?pli=1 |
| Scientific title | The effect of probiotic reinforced laban on saliva PH in patients with fixed orthodontic appliances: A three-arm controlled trial |
| Study acronym | PRL SaPHiOr |
| Study objectives | There is no difference in saliva PH levels in patients with fixed orthodontic appliances who rinse with probiotic-reinforced laban, those who rinse with regular laban, and those who do not rinse. |
| Ethics approval(s) |
Approved 11/02/2024, Taibah University College of Dentistry Research Ethics Committee (TUCD-REC) (Prince Abdulmajeed Ibn Abdulaziz road, Bani Muawiyah, Medinah, 42313, Saudi Arabia; +966 148618888, 77439; tucdrec@taibahu.edu.sa), ref: TUCDREC/040224/SJambi |
| Health condition(s) or problem(s) studied | Prevention of enamel demineralization and caries in patients with fixed orthodontic appliances. |
| Intervention | This is a randomized controlled trial investigating the effect of probiotic reinforced laban in comparison to laban not reinforced with probitics and a control group with no treatment. Laban is a yoghurt drink commonly consumed in Saudia Arabia, when it is reinforced with probiotics this may improve salivary PH thus reducing enamel demineralization and caries. Participants will be allocated to one of the three arms by random allocation. The allocation sequence will be generated by an independent researcher. Allocation concealment will be through central randomization; the investigators collecting the data on clinic will contact a central methods center by phone immediately before administering the intervention. Patients will contact a central randomisation site and the interventions administered in the dental clinics. Immediately before the start of the research clinic, an independent researcher will prepare the two interventions (probiotic reinforced and not reinforced laban) in identical plastic cups with plastic covers, these will be coded and labelled to blind the patients, investigators and data collectors. Decoding will only occur after final analysis of the data. The amount of laban prepared in each cup is 30 ml. Trial participants will be asked to take as much as is comfortable for them and asked to rinse their mouth with it without swallowing, and then spit it out in the dental chair spitoon. Then the salivary outcomes will be measured. |
| Intervention type | Other |
| Primary outcome measure | Saliva PH will be measured using PH test strips which is part of the Saliva-Check Buffer kit from GC company at baseline, 15, 30, 60 min. |
| Secondary outcome measures | 1. Unstimulated saliva measured by visual inspection of the lower lip mucosa after drying with a cotton roll at baseline, 15, 30, 60 min 2. Stimulated saliva measured by asking the patient to chew a wax gum pieces and spit in a collection cup at baseline, 15, 30, 60 min 3. Buferring capacity measured by buffer test strips at baseline, 15, 30, 60 min |
| Overall study start date | 07/01/2024 |
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 78 |
| Key inclusion criteria | Patients with fixed orthodontic appliances visiting Taibah University Dental College, Orthodontic department. |
| Key exclusion criteria | 1. Patients who have a known allergy to dairy products or lactose intolerance 2. Patients who never consumed dairy products before 3. History of antimicrobial agents within the past 4 weeks 4. Patient with systematic diseases or taking drugs that may effect salivary pH 5. Patients with recent orthognathic surgery |
| Date of first enrolment | 20/04/2024 |
| Date of final enrolment | 28/02/2025 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Madinah
42353
Saudi Arabia
Sponsor information
University/education
Janadah bin Umayyah Road
Medina
42353
Saudi Arabia
| Phone | +966 148618888 |
|---|---|
| dentistryc@taibahu.edu.sa | |
| Website | https://www.taibahu.edu.sa/Pages/AR/Home.aspx |
"ROR" |
https://ror.org/01xv1nn60 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Safa Jambi, drsjanbi@gmail.com |
Editorial Notes
30/05/2024: Trial's existence confirmed by Taibah University College of Dentistry Research Ethics Committee (TUCD-REC).
