Periodontal DiseasesdPCRNCT06692595
Digital PCR for Quantifying Periodontal Pathobionts
An observational study of Periodontal Diseases, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
Comparison of quantitative polymerase chain reaction (qPCR) and digital polimerase chain reaction (dPCR) quantification of subgingival plaque samples. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- digital PCR
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Sep 2024to 2 Nov 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study comprised of two subject groups. The first group consisted of 20 subjects with periodontitis, who had at least one probing site in each jaw quadrant with pocket depth (PPD) measuring \> 4 mm and positive bleeding on probing (BOP). Periodontitis stage and grade were determined following the 2018 classification system. The second group consisted of 20 volunteers without periodontal pathologies (healthy group), i.e. plaque index \< 10% at baseline visit, absence of periodontal pockets measuring \> 4 mm and no prior periodontal treatment.
For inclusion, each subject had to be systemically healthy and aged 20 to 80 years. Subjects were excluded if they: had less than 5 teeth in each jaw quadrant, regularly used a mouthwash as part of their oral hygiene routine, had received antibiotics during the last 6 months or during the study period, were pregnant or lactating, had a known systemic illness (i.e. HIV/AIDS, diabetes mellitus, cancer, diseases of bone metabolism, diseases affecting wound healing) or were treated with immunosuppressants, chemotherapy, radiation, calcium antagonists, antiepileptics and non-steroidal anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital PCR for Quantifying Periodontal Pathobionts: A Comparative Study With qPCR
Comparison of quantitative polymerase chain reaction (qPCR) and digital polimerase chain reaction (dPCR) quantification of subgingival plaque samples.
- Conditions
- Periodontal Diseases
- Being tested
- digital PCR
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital PCRDiagnostic test
digital PCR quantification of subgingival plaque samples
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis patients | Not described Receives: Diagnostic Test: digital PCR | |
| Individuals with healthy periodontium | Not described Receives: Diagnostic Test: digital PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of targeted bacterial species, expressed as genome equivalents per mL (Geq/mL), normalized for ribosomal gene copy number per cell
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start3 Sep 2024
- Primary completion20 Oct 2024
- Study completion2 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rok Gašperšič, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692595
- Sponsor's protocol ID
- UKCdPCR1
- Other IDs
- J7-4639
- Acronym
- dPCR
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital PCR for Quantifying Periodontal Pathobionts: A Comparative Study With qPCR
- ClinicalTrials.gov ID
- NCT06692595
- Acronym / sponsor ID
- dPCR / UKCdPCR1
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 18 Nov 2024 (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.
Comparison of quantitative polymerase chain reaction (qPCR) and digital polimerase chain reaction (dPCR) quantification of subgingival plaque samples.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis patients | – | Diagnostic Test: digital PCR |
| Individuals with healthy periodontium | – | Diagnostic Test: digital PCR |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study comprised of two subject groups. The first group consisted of 20 subjects with periodontitis, who had at least one probing site in each jaw quadrant with pocket depth (PPD) measuring \> 4 mm and positive bleeding on probing (BOP). Periodontitis stage and grade were determined following the 2018 classification system. The second group consisted of 20 volunteers without periodontal pathologies (healthy group), i.e. plaque index \< 10% at baseline visit, absence of periodontal pockets measuring \> 4 mm and no prior periodontal treatment.
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 |
|---|---|---|
| digital PCRdigital PCR quantification of subgingival plaque samples | Diagnostic test | Individuals with healthy periodontium, Periodontitis patients |
Primary outcome
concentration of targeted bacterial species, expressed as genome equivalents per mL (Geq/mL), normalized for ribosomal gene copy number per cell
Time frame: Baseline
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 18 Nov 2024.
- 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?
An observational study of Periodontal Diseases, run by University of Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Nov 2024. 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 Slovenia. 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?
concentration of targeted bacterial species, expressed as genome equivalents per mL (Geq/mL), normalized for ribosomal gene copy number per cell (time frame: Baseline). 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 18 Nov 2024.