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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06262035
• Other study ID #: 2023-02987-01
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2024
• Source: Karolinska Institutet
• Contact: Carl Titusson, DDS, MSc
• Phone: +4685088126
• Email: carl.titusson[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peri-implantitis
• Periodontitis

Intervention

Other:
• Periodontitis and Peri-implantitis
Defined periodontitis at = 2 non-adjacent teeth AND Defined peri-implantitis at = 1 implant, in function of at least 1 year.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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