NCT06262035 Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases
| NCT ID | NCT06262035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Peri-implantitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-06-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
1. To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis. 2. To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated.
Eligibility Criteria
Inclusion Criteria: ≥18 years of age Defined periodontitis at two non-adjacent teeth Defined peri-implantitis at ≥1 implant Signed informed consent Exclusion Criteria: Surgical intervention of periodontitis and/or peri-implantitis during last 6 months. Local or systemic use of antibiotics during last 6 months.
Contact & Investigator
Tülay Lindberg, Ass.prof
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06262035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peri-implantitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06262035 currently recruiting?
Yes, NCT06262035 is actively recruiting participants. Contact the research team at carl.titusson@ki.se for enrollment information.
Where is the NCT06262035 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06262035 clinical trial?
NCT06262035 is sponsored by Karolinska Institutet. The principal investigator is Tülay Lindberg, Ass.prof at Karolinska Institutet. The trial plans to enroll 30 participants.