NCT07869277

Brief Summary

This prospective controlled clinical study included 80 participants allocated into four groups according to body mass index (BMI) and periodontal status: obese periodontitis, normal-weight periodontitis, obese periodontally healthy, and normal-weight periodontally healthy. Clinical periodontal parameters and salivary levels of IL-6, IL-10, TNF-α, and adiponectin were assessed at baseline in all participants. Individuals with periodontitis received non-surgical periodontal therapy, and clinical and biochemical evaluations were repeated after 3 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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

January 6, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2015

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

April 22, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

obesityinflammationperiodontal therapysalivacytokines

Outcome Measures

Primary Outcomes (2)

  • Change in Probing Pocket Depth (PPD) After Non-Surgical Periodontal Therapy

    Probing pocket depth (PPD) was measured in millimeters using a Williams periodontal probe at baseline and at the 3-month follow-up. The change from baseline to 3 months was calculated to assess the clinical response to non-surgical periodontal therapy.

    Baseline to 3 months

  • Change in Clinical Attachment Level (CAL) After Non-Surgical Periodontal Therapy

    Clinical attachment level (CAL) was measured in millimeters using a Williams periodontal probe at baseline and at the 3-month follow-up. The change from baseline to 3 months was calculated to assess the clinical response to non-surgical periodontal therapy.

    Baseline to 3 months

Study Arms (4)

Obese Patients with Periodontitis

EXPERIMENTAL

Participants with a body mass index (BMI) ≥30 kg/m² diagnosed with periodontitis. Clinical periodontal parameters and salivary inflammatory biomarkers were recorded at baseline. Non-surgical periodontal therapy (scaling and root planing) was performed, and clinical and biochemical outcomes were re-evaluated following treatment.

Procedure: Scaling and Root Planing (SRP)

Normal weight + Periodontitis

EXPERIMENTAL

Participants with a BMI between 18.5-24.9 kg/m² diagnosed with periodontitis. Baseline clinical periodontal measurements and salivary inflammatory biomarkers were assessed. Non-surgical periodontal therapy was provided, and post-treatment clinical and inflammatory responses were analyzed.

Procedure: Scaling and Root Planing (SRP)

Participants with a BMI between 18.5-24.9 kg/m² diagnosed with periodontitis. Baseline clinical peri

NO INTERVENTION

Participants with a BMI ≥30 kg/m² and no clinical signs of periodontitis. Clinical periodontal parameters and salivary inflammatory biomarkers were assessed at baseline. No periodontal treatment was administered.

Normal weight healthy

NO INTERVENTION

articipants with a BMI between 18.5-24.9 kg/m² and clinically healthy periodontal tissues. Baseline clinical and salivary inflammatory parameters were recorded. No intervention was performed.

Interventions

Non-surgical periodontal therapy consisting of scaling and root planing was performed using hand and ultrasonic instruments under local anesthesia when necessary. Supra- and subgingival plaque and calculus were removed. Oral hygiene instructions were provided to all participants. Treatment was completed within the standard clinical protocol.

Normal weight + PeriodontitisObese Patients with Periodontitis

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For periodontitis groups: diagnosis of periodontitis according to clinical criteria (presence of periodontal pockets and clinical attachment loss)
  • For healthy control groups: absence of clinical signs of periodontitis
  • Body mass index (BMI) ≥30 kg/m² for obese groups
  • Body mass index (BMI) 18.5-24.9 kg/m² for normal-weight groups
  • Systemically healthy individuals
  • No periodontal treatment within the previous 6 months
  • Willingness to participate and provide informed consent -

You may not qualify if:

  • Use of antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the past 3 months
  • Periodontal treatment within the previous 6 months
  • Current pregnancy or lactation
  • History of smoking or current tobacco use
  • Presence of acute oral infections other than periodontitis
  • Any condition that could interfere with study participation or outcome assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PeriodontitisObesityInflammation

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

April 22, 2026

First Posted

October 9, 2026

Study Start

January 6, 2015

Primary Completion

April 8, 2015

Study Completion

July 7, 2015

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

ndividual participant data will not be shared due to ethical and privacy considerations, as the original informed consent did not include provisions for public data sharing.