Digital PCR for Quantifying Periodontal Pathobionts

NCT06692595 | Completed

• 2 other identifiers: UKCdPCR1J7-4639
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of quantitative polymerase chain reaction (qPCR) and digital polimerase chain reaction (dPCR) quantification of subgingival plaque samples.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• concentration of targeted bacterial species, expressed as genome equivalents per mL (Geq/mL), normalized for ribosomal gene copy number per cell

  Baseline

Study Arms (2)

Periodontitis patients

Diagnostic Test: digital PCR

Individuals with healthy periodontium

Diagnostic Test: digital PCR

Interventions

digital PCR DIAGNOSTIC_TEST

digital PCR quantification of subgingival plaque samples

Individuals with healthy periodontium; Periodontitis patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Subgingival plaque sample

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., PhD

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: September 3, 2024
• Primary Completion: October 20, 2024
• Study Completion: November 2, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)