PeriodontitisNCT07869277
Obesity and Clinical and Cytokine Responses to Periodontal Therapy
A study testing Scaling and Root Planing (SRP) in people with Periodontitis and Obesity (Body Mass Index >30 kg/m2), run by Emine Çifcibaşı.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Obesity (Body Mass Index >30 kg/m2)
- What is being tested?
- Scaling and Root Planing (SRP)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2015to 7 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
- -
Who cannot join
None listed.
About this study
Official title: Evaluation of Biochemical and Periodontal Parameters in Obese Individuals
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.
- Conditions
- Periodontitis, Obesity (Body Mass Index >30 kg/m2)
- Being tested
- Scaling and Root Planing (SRP)
- Keywords
- obesity, inflammation, periodontal therapy, saliva, cytokines
- Medical subject headings
- Periodontitis, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root Planing (SRP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start6 Jan 2015
- Primary completion8 Apr 2015
- Study completion7 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emine Çifcibaşı
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Emine Çifcibaşı, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869277
- Sponsor's protocol ID
- 22/08/2104-14
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biochemical and Periodontal Parameters in Obese Individuals
- ClinicalTrials.gov ID
- NCT07869277
- Acronym / sponsor ID
- 22/08/2104-14
- Conditions
- Periodontitis, Obesity (Body Mass Index >30 kg/m2)
- Keywords
- obesity, inflammation, periodontal therapy, saliva, cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Emine ÇifcibaşıUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 6 Jan 2015 (actual)
- Primary completion
- 8 Apr 2015 (actual)
- Study completion
- 7 Jul 2015 (actual)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese Patients with Periodontitis | Experimental | Procedure: Scaling and Root Planing (SRP)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. |
| Normal weight + Periodontitis | Experimental | Procedure: Scaling and Root Planing (SRP)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. |
| 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling 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. | Procedure or surgery | Normal weight + Periodontitis, Obese Patients with Periodontitis |
Primary outcome
Change in Probing Pocket Depth (PPD) After Non-Surgical Periodontal Therapy
Time frame: Baseline to 3 months
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.
Change in Clinical Attachment Level (CAL) After Non-Surgical Periodontal Therapy
Time frame: Baseline to 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing (SRP) in people with Periodontitis and Obesity (Body Mass Index >30 kg/m2), run by Emine Çifcibaşı.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) After Non-Surgical Periodontal Therapy (time frame: Baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.