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CompletedNCT07869277Updated Oct 9, 2026

Obesity and Clinical and Cytokine Responses to Periodontal Therapy

An interventional study of Scaling and Root Planing (SRP) in Periodontitis and Obesity (Body Mass Index >30 kg/m2), sponsored by Emine Çifcibaşı. Completed. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Emine Çifcibaşı · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 years 3 months after the study started (first participant enrolled Jan 2015, registered Apr 2026).
Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

This study was designed to investigate the interaction between obesity and periodontitis in terms of clinical periodontal status and systemic inflammatory burden, as well as to evaluate whether obesity modifies the response to non-surgical periodontal therapy.

Participants were categorized into four groups according to body mass index (BMI) and periodontal status: obese individuals with periodontitis, normal-weight individuals with periodontitis, obese periodontally healthy controls, and normal-weight periodontally healthy controls. Clinical periodontal parameters, including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP), were recorded at baseline. Salivary inflammatory biomarkers, including C-reactive protein (CRP) and interleukin-6 (IL-6), were analyzed to assess systemic and local inflammatory profiles.

Non-surgical periodontal therapy was performed in participants diagnosed with periodontitis. Clinical and salivary parameters were re-evaluated following treatment to determine therapeutic response.

The primary objectives were: (1) to assess whether obesity is associated with differences in baseline periodontal and inflammatory parameters, and (2) to determine whether obesity influences the clinical and inflammatory outcomes of non-surgical periodontal therapy.

02

Conditions studied

  • Periodontitis
  • Obesity (Body Mass Index >30 kg/m2)

Keywords

  • obesity
  • inflammation
  • periodontal therapy
  • saliva
  • cytokines
03

In context

Periodontitis

1,664 studies on the registry are indexed under Periodontitis; 328 are open to participants now.

This study's enrollment of 80 is above the median of 45 across 1,206 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

This is the only study on the registry with Emine Çifcibaşı as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: Adults aged 25-50 years

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 -

Exclusion Criteria: Presence of systemic diseases that could affect periodontal status or inflammatory response (e.g., diabetes mellitus, autoimmune disorders)

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

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Obese Patients with Periodontitis

    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)

  • Experimental
    Normal weight + Periodontitis

    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)

  • No intervention
    Participants with a BMI between 18.5-24.9 kg/m² diagnosed with periodontitis. Baseline clinical peri

    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.

  • No intervention
    Normal weight healthy

    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

  • ProcedureScaling and Root Planing (SRP)

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 3 months

  2. 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.

    Time frame: Baseline to 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Study protocol · Aug 22, 2014
  • Statistical analysis plan · Aug 22, 2014
  • Informed consent form · Aug 22, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Apr 2015, 3 months.

Of 605 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 3 months is below that.

Counting every sponsor, half of 624 studies reached it within 15 months; a quarter within 7 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 22, 2026
First posted
Oct 9, 2026
StartActual
Jan 6, 2015
Primary completionActual
Apr 8, 2015
CompletionActual
Jul 7, 2015
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869277
Lead sponsor
Emine Çifcibaşı
Responsible party
Emine Çifcibaşı (Assoc.Prof., Istanbul University) — Sponsor-investigator
First posted
Oct 9, 2026
Start date
Jan 6, 2015
Primary completion
Apr 8, 2015
Completion
Jul 7, 2015
Last update
Oct 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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