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Clinical Trials/NCT06262035
NCT06262035RecruitingNot Applicable

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

Karolinska Institutet1 site in 1 country30 target enrollmentStarted: June 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Protein levels in peri-implantitis and periodontitis

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tülay Yucel Lindberg

Associate Professor

Karolinska Institutet

Study Sites (1)

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