PeriodontitisNCT02520375
Effects of Prebiotic Oral Healthcare Products as an Adjunct to Non-surgical Periodontal Therapy
A study testing Prebiotic in people with Periodontitis, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 40 patients
- ≥ 36 years of age
- Page 4 of 4 [DRAFT] -
- No previous scaling and rootplaning
- Clinical diagnosis: severe generalized periodontitis characterized by the presence of > 14 affected teeth when > 14 teeth are present (if number of teeth present is < 14, 8-14 teeth need to be affected) with an attachment loss of > 6mm prior to initial non-surgical periodontal therapy.
- A minimum of 3 natural teeth in every quadrant
- Willing and able to give written informed consent
Who cannot join
- Patients with aggressive periodontitis or necrotizing periodontitis
- Patients who smoke
- Pregnant or lactating woman
- A history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal antiinflammatory drugs)
- Patients with poorly controlled diabetes
- Patients taking bisphosphonate mediation
- Patient who have taken systemic antibiotics 3 months prior to treatment
About this study
The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning.
Read the detailed description
The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning. Study design: this study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients. Study population: adults, who consult at the department of Periodontology at the University Hospital Leuven and who fit the inclusion criteria will be asked to participate in this study.
- Conditions
- Periodontitis
- Being tested
- Prebiotic, Control
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticOther
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | This group will be administered a prebiotic mouthrinse and toothpaste Receives: Other: Prebiotic |
| Control | Placebo comparator | This group will be administered a control mouthrinse and toothpaste Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket Probing Depth (PPD) at teeth with residual pockets
Pocket probing depth measured with Merrit B prob
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Primary completionDec 2017 (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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520375
- Sponsor's protocol ID
- s58074
- Status last verified
- Mar 2017
- First submitted
- 1 Jul 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prebiotic Oral Healthcare Products as an Adjunct to Non-surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT02520375
- Acronym / sponsor ID
- s58074
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Primary completion
- Dec 2017 (estimated)
- First posted
- 11 Aug 2015 (estimated)
- 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 aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning.
Detailed description
The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning. Study design: this study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients. Study population: adults, who consult at the department of Periodontology at the University Hospital Leuven and who fit the inclusion criteria will be asked to participate in this study.
Study design
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Other: PrebioticThis group will be administered a prebiotic mouthrinse and toothpaste |
| Control | Placebo comparator | Other: ControlThis group will be administered a control mouthrinse and toothpaste |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 40 patients
- ≥ 36 years of age
- No previous scaling and rootplaning
- Clinical diagnosis: severe generalized periodontitis characterized by the presence of > 14 affected teeth when > 14 teeth are present (if number of teeth present is < 14, 8-14 teeth need to be affected) with an attachment loss of > 6mm prior to initial non-surgical periodontal therapy.
- A minimum of 3 natural teeth in every quadrant
Key exclusion criteria (7 listed)
- Patients with aggressive periodontitis or necrotizing periodontitis
- Patients who smoke
- Pregnant or lactating woman
- A history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal antiinflammatory drugs)
- Patients with poorly controlled diabetes
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 |
|---|---|---|
| Prebiotic | Other | Prebiotic |
| Control | Other | Control |
Primary outcome
Pocket Probing Depth (PPD) at teeth with residual pockets
Time frame: Baseline - 6 months
Pocket probing depth measured with Merrit B prob
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Periodontitis, run by Universitaire Ziekenhuizen KU Leuven.
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 7 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pocket Probing Depth (PPD) at teeth with residual pockets (time frame: Baseline - 6 months). 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 14 Mar 2017.