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

NCT06262035 | Recruiting

• 1 other identifier: 2023-02987-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Peri-implantitis; Periodontitis

Keywords

Peri-implantitis; Periodontitis

Outcome Measures

Primary Outcomes (3)

• Protein levels in peri-implantitis and periodontitis

  To measure protein levels in gingival crevicular fluid and in peri-implant crevicular fluid.

  Through study completion, an average of 1 years

• Microbiome composition in peri-implantitis and periodontitis using 16S-rRNA sequencing method.

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

  Through study completion, an average of 1 years

• Gene expression profile in peri-implantitis and periodontitis.

  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.

  Through study completion, an average of 1 years

Interventions

Periodontitis and Peri-implantitis OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥18 years of age Defined periodontitis at two non-adjacent teeth Defined peri-implantitis at ≥1 implant Signed informed consent

You may not qualify if:

• Surgical intervention of periodontitis and/or peri-implantitis during last 6 months.
• Local or systemic use of antibiotics during last 6 months.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Aqua Dental Specialistklinik

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Gingival crevicular fluid Peri-implant crevicular fluid Soft tissue biopsies

MeSH Terms

Conditions

Peri-Implantitis; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Tülay Lindberg, Ass.prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Titusson, DDS, MSc

CONTACT

+4685088126; carl.titusson@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 15, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)