Periodontitis (Stage 3)TSTGNCT07272980
Three-Session Non-Surgical Periodontal Therapy Improves Biochemical and Microbiological Profiles in Patients With Severe Grade C Periodontitis
A study testing Scaling and Root Planing (SRP) in people with Periodontitis (Stage 3) and Periodontitis Stage III, run by Gülnur Emingil at 1 site in Turkey (Türkiye).
Trial summary
This clinical study investigates two different non-surgical periodontal therapy approaches in patients with advanced periodontitis and compares them with periodontally healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis (Stage 3), Periodontitis Stage III
- 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
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2010to 22 May 2011
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy, non-smoking individuals aged 18-65 years
- Diagnosis of Stage III or IV Grade C periodontitis according to the 2018 classification of periodontal diseases
- Presence of at least 20 teeth
- No periodontal treatment within the previous 6 months
- Willingness to participate and provide written informed consent
Who cannot join
- Presence of systemic diseases or conditions affecting the periodontium (e.g., diabetes mellitus, cardiovascular diseases, immunological disorders)
- Pregnancy or lactation
- Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the past 3 months
- History of periodontal therapy or surgery within the last 6 months
- Smoking or use of any tobacco products
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University, School of Dentistry
Istanbul, Turkey, 34408
About this study
This clinical study investigates two different non-surgical periodontal therapy approaches in patients with advanced periodontitis and compares them with periodontally healthy individuals. Participants with Stage III/IV Grade C periodontitis are randomly assigned to either a single-session or a three-session scaling and root planing (SRP) protocol. Clinical parameters, gingival crevicular fluid inflammatory markers, and subgingival microbial profiles are assessed at baseline and during a 6-month follow-up period. The study aims to determine whether performing non-surgical periodontal therapy in multiple sessions influences clinical, biochemical, and microbiological responses.
Read the detailed description
This randomized, single-blinded, controlled clinical trial is conducted at the Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey. The purpose of the study is to evaluate whether a three-session non-surgical periodontal therapy protocol provides different clinical, biochemical, and microbiological responses compared to a single-session protocol in patients with Stage III/IV Grade C periodontitis.
Participants with periodontitis are randomly assigned to one of two intervention groups:
Single-Session Therapy Group (SSTG): full-mouth scaling and root planing (SRP) performed in one visit.
Three-Session Therapy Group (TSTG): quadrant-wise SRP delivered over three sessions within the same week.
All procedures are carried out by a single calibrated clinician. Clinical periodontal parameters-probing depth, clinical attachment level, plaque index, and bleeding on probing-are recorded at baseline and at predetermined follow-up visits at 1, 3, and 6 months.
Gingival crevicular fluid samples are collected to quantify inflammatory biomarkers, including interleukin-1β (IL-1β), interleukin-6 (IL-6), clusterin, cystatin C, and osteocalcin, using multiplex immunoassays. Subgingival microbial profiles are evaluated using checkerboard DNA-DNA hybridization targeting a panel of selected bacterial species.
The study protocol has received ethics approval from the Ege University School of Medicine Ethics Committee, and written informed consent is obtained from all participants. The research is supported by the Scientific Research Projects Coordination Unit of Ege University.
- Conditions
- Periodontitis (Stage 3), Periodontitis Stage III
- Being tested
- Scaling and Root Planing (SRP)
- Keywords
- non-surgical periodontal therapy, scaling and root planning, periodontitis
- Medical subject headings
- Periodontitis
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
Full-mouth scaling and root planing (SRP) performed under local anesthesia, either in a single session or divided into three weekly sessions depending on the study arm. Standard oral hygiene instructions were provided to all participants.
| Study group | Role | What they receive |
|---|---|---|
| Single-session non-surgical periodontal therapy | Experimental | Participants received full-mouth scaling and root planing (SRP) completed in a single session under local anesthesia. Standard oral hygiene instructions were provided. Receives: Procedure: Scaling and Root Planing (SRP) |
| Three-session non-surgical periodontal therapy | Experimental | Participants received full-mouth scaling and root planing (SRP) over three consecutive weekly sessions under local anesthesia. Standard oral hygiene instructions were provided. Receives: Procedure: Scaling and Root Planing (SRP) |
| Healthy control group | No intervention | Periodontally healthy participants without clinical attachment loss or probing depths ≥4 mm were examined and sampled but received no periodontal treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Full-Mouth Mean Probing Depth (PD)
Mean change in probing depth (in millimeters) measured at six sites per tooth from baseline to 6 months.
Measured: Baseline to 6 months
Secondary outcomes (5)
Change in Clinical Attachment Level (CAL)
Evaluation of changes in CAL (mm) at six sites per tooth to assess periodontal healing and inflammation following single-session versus three-session scaling and root planing (SRP).
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Bleeding on Probing (BOP)
Change in BOP (%), measured as the percentage of sites exhibiting bleeding on gentle probing, to assess gingival inflammation.
Measured: Baseline, 1 month, 3 months, 6 months
Change in Plaque Index (PI)
Change in PI to evaluate supragingival plaque levels, assessed as the percentage of tooth surfaces with visible supragingival plaque, to evaluate the level of supragingival biofilm accumulation.
Measured: Baseline, 1 month, 3 months, 6 months
Change in Gingival Crevicular Fluid Biomarker Levels (Clusterin, Cystatin C, IL-1β, IL-6, and Osteocalcin)
GCF samples collected from sites with PD ≥ 5 mm will be analyzed using multiplex immunoassay to determine changes in host-response biomarkers reflecting tissue inflammation and repair.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Subgingival Microbiota Composition
Quantitative and qualitative assessment of periodontal pathogens (e.g., A. actinomycetemcomitans, P. gingivalis, T. denticola, T. forsythia, F. nucleatum) via DNA-DNA checkerboard hybridization to evaluate microbiological effects of SRP regimens.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start21 Nov 2010
- Primary completion22 May 2011
- Study completion22 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with Stage III/IV Grade C periodontitis were randomly assigned to one of two treatment groups: a single-session scaling and root planing (SRP) protocol or a three-session SRP protocol. Both groups received the allocated intervention in parallel and were followed for 6 months. A healthy control group was also included for comparison.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gülnur Emingil
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University Scientific Research Projects Coordination Unit
- Responsible party
- Sponsor-investigator, Gülnur Emingil, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272980
- Sponsor's protocol ID
- 2012-DİŞ-006
- Acronym
- TSTG
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) underlying this article will not be shared because anonymized patient-level data were analyzed only in aggregate form, and no separate data repository was created for public access. Summary results are fully presented in the published article.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Session Non-Surgical Periodontal Therapy Improves Biochemical and Microbiological Profiles in Patients With Severe Grade C Periodontitis
- ClinicalTrials.gov ID
- NCT07272980
- Acronym / sponsor ID
- TSTG / 2012-DİŞ-006
- Conditions
- Periodontitis (Stage 3), Periodontitis Stage III
- Keywords
- non-surgical periodontal therapy, scaling and root planning, periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gülnur EmingilUniversity, hospital or other
- Collaborators
- Ege University Scientific Research Projects Coordination Unit
- Study start
- 21 Nov 2010 (actual)
- Primary completion
- 22 May 2011 (actual)
- Study completion
- 22 May 2011 (actual)
- First posted
- 9 Dec 2025 (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 clinical study investigates two different non-surgical periodontal therapy approaches in patients with advanced periodontitis and compares them with periodontally healthy individuals. Participants with Stage III/IV Grade C periodontitis are randomly assigned to either a single-session or a three-session scaling and root planing (SRP) protocol. Clinical parameters, gingival crevicular fluid inflammatory markers, and subgingival microbial profiles are assessed at baseline and during a 6-month follow-up period. The study aims to determine whether performing non-surgical periodontal therapy in multiple sessions influences clinical, biochemical, and microbiological responses.
Detailed description
This randomized, single-blinded, controlled clinical trial is conducted at the Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey. The purpose of the study is to evaluate whether a three-session non-surgical periodontal therapy protocol provides different clinical, biochemical, and microbiological responses compared to a single-session protocol in patients with Stage III/IV Grade C periodontitis.
Participants with periodontitis are randomly assigned to one of two intervention groups:
Single-Session Therapy Group (SSTG): full-mouth scaling and root planing (SRP) performed in one visit.
Three-Session Therapy Group (TSTG): quadrant-wise SRP delivered over three sessions within the same week.
All procedures are carried out by a single calibrated clinician. Clinical periodontal parameters-probing depth, clinical attachment level, plaque index, and bleeding on probing-are recorded at baseline and at predetermined follow-up visits at 1, 3, and 6 months.
Gingival crevicular fluid samples are collected to quantify inflammatory biomarkers, including interleukin-1β (IL-1β), interleukin-6 (IL-6), clusterin, cystatin C, and osteocalcin, using multiplex immunoassays. Subgingival microbial profiles are evaluated using checkerboard DNA-DNA hybridization targeting a panel of selected bacterial species.
The study protocol has received ethics approval from the Ege University School of Medicine Ethics Committee, and written informed consent is obtained from all participants. The research is supported by the Scientific Research Projects Coordination Unit of Ege University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants with Stage III/IV Grade C periodontitis were randomly assigned to one of two treatment groups: a single-session scaling and root planing (SRP) protocol or a three-session SRP protocol. Both groups received the allocated intervention in parallel and were followed for 6 months. A healthy control group was also included for comparison.
| Arm | Type | Receives |
|---|---|---|
| Single-session non-surgical periodontal therapy | Experimental | Procedure: Scaling and Root Planing (SRP)Participants received full-mouth scaling and root planing (SRP) completed in a single session under local anesthesia. Standard oral hygiene instructions were provided. |
| Three-session non-surgical periodontal therapy | Experimental | Procedure: Scaling and Root Planing (SRP)Participants received full-mouth scaling and root planing (SRP) over three consecutive weekly sessions under local anesthesia. Standard oral hygiene instructions were provided. |
| Healthy control group | No intervention | –Periodontally healthy participants without clinical attachment loss or probing depths ≥4 mm were examined and sampled but received no periodontal treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy, non-smoking individuals aged 18-65 years
- Diagnosis of Stage III or IV Grade C periodontitis according to the 2018 classification of periodontal diseases
- Presence of at least 20 teeth
- No periodontal treatment within the previous 6 months
- Willingness to participate and provide written informed consent
Key exclusion criteria (5 listed)
- Presence of systemic diseases or conditions affecting the periodontium (e.g., diabetes mellitus, cardiovascular diseases, immunological disorders)
- Pregnancy or lactation
- Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the past 3 months
- History of periodontal therapy or surgery within the last 6 months
- Smoking or use of any tobacco products
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)Full-mouth scaling and root planing (SRP) performed under local anesthesia, either in a single session or divided into three weekly sessions depending on the study arm. Standard oral hygiene instructions were provided to all participants. | Procedure or surgery | Single-session non-surgical periodontal therapy, Three-session non-surgical periodontal therapy |
Primary outcome
Change in Full-Mouth Mean Probing Depth (PD)
Time frame: Baseline to 6 months
Mean change in probing depth (in millimeters) measured at six sites per tooth from baseline to 6 months.
5 secondary outcomes
Change in Clinical Attachment Level (CAL)
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Bleeding on Probing (BOP)
Time frame: Baseline, 1 month, 3 months, 6 months
Change in Plaque Index (PI)
Time frame: Baseline, 1 month, 3 months, 6 months
Change in Gingival Crevicular Fluid Biomarker Levels (Clusterin, Cystatin C, IL-1β, IL-6, and Osteocalcin)
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Subgingival Microbiota Composition
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
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 15 Dec 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) underlying this article will not be shared because anonymized patient-level data were analyzed only in aggregate form, and no separate data repository was created for public access. Summary results are fully presented in the published article.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing (SRP) in people with Periodontitis (Stage 3) and Periodontitis Stage III, run by Gülnur Emingil at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Full-Mouth Mean Probing Depth (PD) (time frame: Baseline to 6 months). 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 15 Dec 2025.