NCT07526883

Brief Summary

The goal of this clinical study was to evaluate whether non-surgical treatment for severe periodontitis (gum disease) could improve body-wide inflammation and blood fat levels in young adults with severe periodontitis. The main questions it aimed to answer were: Did non-surgical periodontal treatment improve gum health in young adults with severe periodontitis? Did non-surgical periodontal treatment change body-wide inflammation and blood fat levels after treatment? Researchers compared participants with severe periodontitis to healthy participants without periodontitis. Participants with severe periodontitis:

  • Received oral hygiene instructions, deep cleaning below the gumline, root surface cleaning, and removal of teeth that could not be saved
  • Had full-mouth gum examinations
  • Provided blood samples at the start of the study and again at 2 and 6 months after treatment Healthy participants:
  • Had gum examinations
  • Provided blood samples for comparison at the start of the study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
15.8 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

March 13, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

InflammationPeriodontal DebridementPeriodontitisSystemic Biomarkers

Outcome Measures

Primary Outcomes (15)

  • The change in serum high-sensitivity C-reactive protein (hs-CRP) concentration after periodontal treatment

    This change is measured in serum, as mg/dl, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. The study was powered on the change in this parameter from baseline to 6 months after treatment.

    6 months

  • The change in HDL cholesterol concentration after periodontal treatment

    This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in LDL cholesterol concentration after periodontal treatment

    This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in total cholesterol concentration after periodontal treatment

    This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in triglyceride concentration after periodontal treatment

    This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in albumin concentration after periodontal treatment

    This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in von Willebrand factor (vWf) level after periodontal treatment

    This parameter is measured in blood samples, as percentage (%), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in creatinine concentration after periodontal treatment

    This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in fibrinogen concentration after periodontal treatment

    This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in Factor VII level after periodontal treatment

    This parameter is measured in blood samples, as percentage (%), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in interleukin-1 receptor (IL-1ra) antagonist concentration after periodontal treatment

    This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in interleukin-6 (IL-6) level after periodontal treatment

    This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in soluble tumor necrosis factor receptor I (sTNFRI) concentration after periodontal treatment

    This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in soluble tumor necrosis factor receptor II concentration (sTNFRII) after periodontal treatment

    This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

  • The change in tissue plasminogen activator (tPA) concentration after periodontal treatment

    This parameter is measured in blood samples, as ng/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.

    6 months

Secondary Outcomes (5)

  • The change in sulcus bleeding index (SBI) after periodontal treatment

    6 months

  • The change in plaque index (PI) after periodontal treatment

    6 months

  • The change in clinical attachment level (CAL) after periodontal treatment

    6 months

  • The change in probing pocket depth (PPD) after periodontal treatment

    6 months

  • The change in level of gingival margin (LGM) after periodontal treatment

    6 months

Study Arms (2)

Healthy Group

NO INTERVENTION

The healthy control arm included systemically and periodontally healthy young adults with no periodontal or systemic disease who met the same exclusion criteria as the periodontitis group. Participants did not receive periodontal treatment. They underwent baseline full-mouth periodontal examination and blood sampling to provide healthy reference values.

Periodontitis Group

ACTIVE COMPARATOR

The periodontitis arm included systemically healthy young adults with severe periodontitis. Participants underwent baseline full-mouth periodontal examination and blood sampling, received non-surgical periodontal treatment, and were re-evaluated at 2 and 6 months after treatment.

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment consisted of oral hygiene instruction, subgingival scaling, root planing, and extraction of unsalvageable teeth under local anesthesia. Treatment was completed within 1 week. Clinical periodontal measurements and blood samples were obtained at baseline and repeated at 2 and 6 months after completion of treatment.

Periodontitis Group

Eligibility Criteria

Age19 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults aged 19 to 36 years
  • At least 20 teeth present
  • Clinical attachment loss of at least 5 mm affecting at least 8 teeth
  • Bone loss around at least 3 teeth other than incisors and first molars

You may not qualify if:

  • Systemic disease
  • Pregnancy or lactation
  • Current or former smoking
  • Systemic conditions that could alter the host response
  • Medical conditions requiring antibiotic prophylaxis during routine dental procedures
  • Antibiotic therapy within the previous 6 months
  • Previous periodontal treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Faculty of Dentistry, Department of Periodontology

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Aggressive PeriodontitisInflammationPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 13, 2026

First Posted

April 13, 2026

Study Start

July 1, 2006

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations