NCT07503041

Brief Summary

This study investigates inflammatory biomarkers in gingival crevicular fluid (GCF) from smokers and non-smokers with severe periodontitis, before and during non-surgical periodontal therapy (NSPT). During periodontal disease development the periodontal pockets become deeper. In the inflamed periodontal tissue the interstitial fluid is filtered out into the periodontal pocket. The GCF reflects local inflammatory activity and contains cytokines/chemokines that may serve as biomarkers for disease severity and treatment response. Investigators aim at collecting GCF from periodontal pockets from each patients before and during NSPT. Investigators compare non-smokers and smokers. The samples will be analysed for pro-inflammatory mediators and investigators aim at biomarkers that are at a high level in deep inflamed periodontal pockets. Investigators also want to observe if these biomarkers are altered in GCF after periodontal therapy. Finally investigators want to compare non-smokers and smokers with respect to treatment outcome and respons of chemokines/cytokines in GCF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

February 5, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Gingival crevicular fluidperiodontal pocketchemokinesinflammation

Outcome Measures

Primary Outcomes (1)

  • Biomarker measurement in GCF

    Analyse the GCF for 40 biomarkers

    Within a period of 5 years

Study Arms (2)

Collecting gingival crevicular fluid

Applying a paperpoint in a periodontal pocket for 30 sec

Other: Collecting fluid for biomarker analysesProcedure: Hygiene instruction, tooth cleaning, plaque removal

Treatment of periodontitis

Non surgical treatment of periodontitis patients

Other: Collecting fluid for biomarker analysesProcedure: Hygiene instruction, tooth cleaning, plaque removal

Interventions

We are looking at spesific biomarkers in GCF that has not been investigated before

Collecting gingival crevicular fluidTreatment of periodontitis
Collecting gingival crevicular fluidTreatment of periodontitis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with severe periodontitis referred to our specialist clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postboks 2354 Møllendal

Bergen, 5867, Norway

Location

MeSH Terms

Conditions

PeriodontitisPeriodontal PocketInflammation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2026

First Posted

March 31, 2026

Study Start

January 8, 2016

Primary Completion

December 21, 2025

Study Completion

December 21, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations