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Clinical Trials/NCT06262035
NCT06262035
Recruiting
Not Applicable

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

Karolinska Institutet1 site in 1 country30 target enrollmentJune 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-implantitis
Sponsor
Karolinska Institutet
Enrollment
30
Locations
1
Primary Endpoint
Protein levels in peri-implantitis and periodontitis
Status
Recruiting
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
June 15, 2024
End Date
December 31, 2030
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tülay Yucel Lindberg

Associate Professor

Karolinska Institutet

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.

Outcomes

Primary Outcomes

Protein levels in peri-implantitis and periodontitis

Time Frame: Through study completion, an average of 1 years

To 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.

Time Frame: Through study completion, an average of 1 years

The microbiome composition will be analyzed in samples of subgingival/submucosal plaque using 16S-rRNA sequencing method.

Gene expression profile in peri-implantitis and periodontitis.

Time Frame: Through study completion, an average of 1 years

Soft 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.

Study Sites (1)

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