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

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aqua Dental Specialistklinik

Stockholm, Sweden

Location status: Recruiting

Location contact

Nilminie Rathnayake, Dr

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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 contacts

Contact information is provided by the study sponsor or research team.

Carl Titusson, DDS, MSc

CONTACT

[email protected]

+4685088126

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2030
First posted: Feb 15, 2024
Registry last updated: Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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