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Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases

Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06262035
Enrollment
30
Registered
2024-02-15
Start date
2024-06-15
Completion date
2030-12-31
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implantitis, Periodontitis

Keywords

Peri-implantitis, Periodontitis

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.

Interventions

OTHERPeriodontitis and Peri-implantitis

Defined periodontitis at ≤ 2 non-adjacent teeth AND Defined peri-implantitis at ≤ 1 implant, in function of at least 1 year.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Protein levels in peri-implantitis and periodontitisThrough study completion, an average of 1 yearsTo measure protein levels in gingival crevicular fluid and in peri-implant crevicular fluid.
Microbiome composition in peri-implantitis and periodontitis using 16S-rRNA sequencing method.Through study completion, an average of 1 yearsThe microbiome composition will be analyzed in samples of subgingival/submucosal plaque using 16S-rRNA sequencing method.
Gene expression profile in peri-implantitis and periodontitis.Through study completion, an average of 1 yearsSoft tissue specimens will be studied in regards of gene expression levels using RNA sequencing method (Ilumina). The mRNA expression of candidate genes will be studied at protein level using immunohistochemistry.

Countries

Sweden

Contacts

Primary ContactCarl Titusson, DDS, MSc
carl.titusson@ki.se+4685088126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026