GingivitisNCT05268757
Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation
A study testing Oral hygiene discontinuation in people with Gingivitis, 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 28 days. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Oral hygiene discontinuation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2022to 1 Jun 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age > 18 yrs.
Who cannot join
- Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
- Current smokers
- Any systemic diseases and current use of any medication with known effect on oral health
- Use of systemic antibiotics within the latest three months
- Age < 18 yrs., and age > 30 yrs.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department of Odontology
Copenhagen, 2200
About this study
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
Read the detailed description
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.
Clinical measurements and sampling will be performed at baseline, day 14 and day 28
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
- Conditions
- Gingivitis
- Being tested
- Oral hygiene discontinuation
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene discontinuationBehavioural
Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care). Receives: Behavioral: Oral hygiene discontinuation |
| Placebo | Placebo comparator | In this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care). Receives: Behavioral: Oral hygiene discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microbial composition in dental
Changes in alpha and beta diversity of microbial composition
Measured: Baseline vs. Day 14 and Day 28
Secondary outcomes (1)
Changes in clinical parameters
Changes in levels of dental plaque and gingival inflammation
Measured: Baseline vs. Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start5 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Prevention
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Deerland Probiotics and Enzymes
- Responsible party
- Principal investigator, Daniel Belstrøm, DDS, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268757
- Sponsor's protocol ID
- UCPH_01_006
- Status last verified
- Aug 2022
- First submitted
- 24 Feb 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation
- ClinicalTrials.gov ID
- NCT05268757
- Acronym / sponsor ID
- UCPH_01_006
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Deerland Probiotics and Enzymes
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 7 Mar 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 28 days.
Detailed description
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.
The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.
Clinical measurements and sampling will be performed at baseline, day 14 and day 28
Primary endpoint: Changes in microbial composition.
Secondary endpoints: Changes in clinical and immunological parameters
Study design
- Primary purpose
- Prevention
- 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 | Behavioral: Oral hygiene discontinuationIn this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care). |
| Placebo | Placebo comparator | Behavioral: Oral hygiene discontinuationIn this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age > 18 yrs.
Key exclusion criteria (5 listed)
- Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
- Current smokers
- Any systemic diseases and current use of any medication with known effect on oral health
- Use of systemic antibiotics within the latest three months
- Age < 18 yrs., and age > 30 yrs.
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 |
|---|---|---|
| Oral hygiene discontinuationOral hygiene discontinuation for 14 days followed by 14 days of regular oral care | Behavioural | Placebo, Probiotic |
Primary outcome
Changes in microbial composition in dental
Time frame: Baseline vs. Day 14 and Day 28
Changes in alpha and beta diversity of microbial composition
1 secondary outcome
Changes in clinical parameters
Time frame: Baseline vs. Day 14 and Day 28
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 23 Aug 2022.
- Individual participant dataSharing planned: No
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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 Oral hygiene discontinuation in people with Gingivitis, 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 5 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 23 Aug 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?
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?
Changes in microbial composition in dental (time frame: Baseline vs. Day 14 and Day 28). 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 23 Aug 2022.