Clinical trial NCT06262035: Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases
Official title: Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peri-implantitis
Periodontitis
Keywords: Peri-implantitis
Periodontitis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with periodontitis and peri-implantitis, referred from a general clinic in Stockholm County to a periodontist.

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.

Primary outcomes:
measure: Protein levels in peri-implantitis and periodontitis
timeFrame: Through study completion, an average of 1 years
measure: Microbiome composition in peri-implantitis and periodontitis using 16S-rRNA sequencing method.
timeFrame: Through study completion, an average of 1 years
measure: Gene expression profile in peri-implantitis and periodontitis.
timeFrame: Through study completion, an average of 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Aqua Dental Specialistklinik
Study officials:
affiliation: Karolinska Institutet
name: Tülay Lindberg, Ass.prof
role: PRINCIPAL_INVESTIGATOR
References: