PeriodontitisNCT05518747
Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
A study testing Probiotic in people with Periodontitis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to 31 Dec 2023
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis stage 2-3, Grade B-C, generalized
Who cannot join
- • Use of systemic antibiotics within the latest three months.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University of Copenhagen, Department of Odontology
Copenhagen, 2200
Daniel Belstrøm, DDS, PhD, +45 21300580, dbel@sund.ku.dk
Merete Markvart, DDS, PhD, +45 35 33 77 65, mema@sund.ku.dk
About this study
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.
Read the detailed description
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks
. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.
Clinical measurements and sampling will be performed at baseline, week 6 and week 12.
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
- Conditions
- Periodontitis
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks.
PlaceboDietary supplement
In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microbial composition in dental plaque
Changes in alpha and beta diversity of microbial composition
Measured: Baseline vs. week 6 and week 12
Secondary outcomes (5)
Changes in dental plaque
Changes in mean level of dental plaque
Measured: Baseline vs. week 6 and week 12
Changes in bleeding on probing
Changes in mean level of bleeding on probing
Measured: Baseline vs. week 6 and week 12
Changes in probing pocket depth
Changes in mean level of probing pocket depth
Measured: Baseline vs. week 6 and week 12
Changes in clinical attachment level
Changes in mean level of clinical attachment level
Measured: Baseline vs. week 6 and week 12
Changes in salivary levels of inflammatory cytokines
Changes in mean salivary levels of selected inflammatory cytokines
Measured: Baseline vs. week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized clinical trial with a test and placebo group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Belstrøm, DDS, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518747
- Sponsor's protocol ID
- UCPH_01_007
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All microbial data will be shared, as these will be uploaded to a publically accessible database. In accordance with GDPR, immunological and clinical data will only be shared as mean (range) values.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT05518747
- Acronym / sponsor ID
- UCPH_01_007
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Aug 2022 (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.
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.
Detailed description
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks
. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.
Clinical measurements and sampling will be performed at baseline, week 6 and week 12.
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized clinical trial with a test and placebo group
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticIn this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIn this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Periodontitis stage 2-3, Grade B-C, generalized
Key exclusion criteria (1 listed)
- • Use of systemic antibiotics within the latest three months.
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 |
|---|---|---|
| ProbioticIn this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks. | Dietary supplement | Probiotic |
| PlaceboIn this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Changes in microbial composition in dental plaque
Time frame: Baseline vs. week 6 and week 12
Changes in alpha and beta diversity of microbial composition
5 secondary outcomes
Changes in dental plaque
Time frame: Baseline vs. week 6 and week 12
Changes in bleeding on probing
Time frame: Baseline vs. week 6 and week 12
Changes in probing pocket depth
Time frame: Baseline vs. week 6 and week 12
Changes in clinical attachment level
Time frame: Baseline vs. week 6 and week 12
Changes in salivary levels of inflammatory cytokines
Time frame: Baseline vs. week 6 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No. All microbial data will be shared, as these will be uploaded to a publically accessible database. In accordance with GDPR, immunological and clinical data will only be shared as mean (range) values.
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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.
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 in people with Periodontitis, run by University of Copenhagen at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in microbial composition in dental plaque (time frame: Baseline vs. week 6 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.