Tooth DecayNCT05859646
Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp
A study testing Probiotic use in people with Tooth Decay and Probiotics, run by Didem Sakaryali Uyar at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the change of S. mutans and Lactobacillus spp. counts after all dental treatments were completed under general anesthesia and compare the groups in case of using probiotics and not using probiotics with the time for 6-months follow-up period. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Decay, Probiotics, Streptococcus Mutans
- What is being tested?
- Probiotic use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Every included child had at least 8 tooth with caries.
Who cannot join
- Patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Streptococcus Mutans and Lactobacillus Species Due to Probiotic Use in Oral Flora
To evaluate the change of S. mutans and Lactobacillus spp. counts after all dental treatments were completed under general anesthesia and compare the groups in case of using probiotics and not using probiotics with the time for 6-months follow-up period.
Read the detailed description
Fifthy-eight pediatric patients without any systemical diseases whose dental treatments were completed under general anesthesia were included in the study. The study was carried out as two-groups; Group A: Patients who started using probiotics after general anesthesia and Group B: Patients who did not use probiotics after general anesthesia. The counts of S. mutans and Lactobacillus spp. were determined by quantitative polymerase chain reaction (qPCR) by analysis of saliva samples taken from all patients on the day before the general anesthesia (T0), at 1-month (T1), 3-month (T2) and 6-month (T3) follow-up periods. The statistical significance level was accepted as p<0.05.
- Conditions
- Tooth Decay, Probiotics, Streptococcus Mutans
- Being tested
- Probiotic use
- Keywords
- tooth caries, probiotics, qPCR, Streptococcus mutans, Lactobacillus
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic useDietary supplement
Also called Follow-up after general anesthesia
Probiotics were used for 3 months and all participated patients were followed for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Group A-Probiotics group: Patients who started using probiotic drops after general anesthesia procedure Receives: Dietary Supplement: Probiotic use |
| Control | No intervention | Group B-Control group: Patients who did not use any probiotics after general anesthesia procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
S mutans count
CFU
Measured: 6 month
Lactobacillus spp count
CFU
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Jan 2020
- Primary completion15 Jan 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 separate groups, experimental and control, 6 month follow-up period, randomized distribution
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Didem Sakaryali Uyar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Didem Sakaryali Uyar, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859646
- Sponsor's protocol ID
- D-KA 19/41
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the study is published, it can be sent to the individual upon reasonable request.
Publications
Sakaryali Uyar D, Uskudar Guclu A, Celik E, Memis Ozgul B, Altay Kocak A, Basustaoglu AC. Evaluation of probiotics' efficiency on cariogenic bacteria: randomized controlled clinical study. BMC Oral Health. 2024 Aug 2;24(1):886. doi: 10.1186/s12903-024-04659-y.
PubMed 39095860
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Streptococcus Mutans and Lactobacillus Species Due to Probiotic Use in Oral Flora
- ClinicalTrials.gov ID
- NCT05859646
- Acronym / sponsor ID
- D-KA 19/41
- Conditions
- Tooth Decay, Probiotics, Streptococcus Mutans
- Keywords
- tooth caries, probiotics, qPCR, Streptococcus mutans, Lactobacillus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Didem Sakaryali UyarUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the change of S. mutans and Lactobacillus spp. counts after all dental treatments were completed under general anesthesia and compare the groups in case of using probiotics and not using probiotics with the time for 6-months follow-up period.
Detailed description
Fifthy-eight pediatric patients without any systemical diseases whose dental treatments were completed under general anesthesia were included in the study. The study was carried out as two-groups; Group A: Patients who started using probiotics after general anesthesia and Group B: Patients who did not use probiotics after general anesthesia. The counts of S. mutans and Lactobacillus spp. were determined by quantitative polymerase chain reaction (qPCR) by analysis of saliva samples taken from all patients on the day before the general anesthesia (T0), at 1-month (T1), 3-month (T2) and 6-month (T3) follow-up periods. The statistical significance level was accepted as p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 separate groups, experimental and control, 6 month follow-up period, randomized distribution
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotic useGroup A-Probiotics group: Patients who started using probiotic drops after general anesthesia procedure |
| Control | No intervention | –Group B-Control group: Patients who did not use any probiotics after general anesthesia procedure |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Every included child had at least 8 tooth with caries.
Key exclusion criteria (1 listed)
- Patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic useAlso: Follow-up after general anesthesiaProbiotics were used for 3 months and all participated patients were followed for 6 months. | Dietary supplement | Probiotics |
Primary outcome
S mutans count
Time frame: 6 month
CFU
Lactobacillus spp count
Time frame: 6 month
CFU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 39095860Sakaryali Uyar D, Uskudar Guclu A, Celik E, Memis Ozgul B, Altay Kocak A, Basustaoglu AC. Evaluation of probiotics' efficiency on cariogenic bacteria: randomized controlled clinical study. BMC Oral Health. 2024 Aug 2;24(1):886. doi: 10.1186/s12903-024-04659-y.
- Individual participant dataSharing planned: No. After the study is published, it can be sent to the individual upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic use in people with Tooth Decay and Probiotics, run by Didem Sakaryali Uyar at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S mutans count (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.