Peridontal DiseaseNCT07243145
Analysis of the Impact of Contemporary Subgingival Debridement Techniques on Immunological Biomarkers in Gingival Crevicular Fluid
An observational study of Peridontal Disease and Periodontal Inflammation, run by Selcen Ozcan Bulut at 1 site in Turkey (Türkiye).
Trial summary
AIM: This prospective clinical study aimed to evaluate the efficacy of two distinct non-surgical periodontal therapy modalities in patients diagnosed with Stage 1 and Stage 2 periodontitis. METHOD: The study comprised 80 nonsmoking, systemically healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Peridontal Disease, Periodontal Inflammation, Periodontitis, Adult
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 15 May 2025
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who applied to Niğde Ömer Halisdemir University Faculty of Dentistry Periodontics Clinic between 15.10.2024 and 15.12.2024 for periodontal treatment, volunteered to participate in the study and met the following criteria were included in the study. Written consent was obtained from volunteer patients for the research. The patients were evaluated by a single periodontologist (SND), and patients with mild to moderate periodontitis (Stage 1-2) who required supragingival and subgingival calculus removal were included in the study.
Who may be able to join
- Systemically healthy (no known chronic diseases)
- Completed periodontal diagnostic data (Gingival Index, Plaque Index, Periodontal pocket depths, Attachment loss, Radiological data, and Bone loss data)
- Did not take anti-inflammatory drugs in the previous month
- Volunteered to participate with Stage 1-2 periodontitis.
Who cannot join
- Patients with systemic diseases
- Pregnant or lactating patients
- Smokers
- Patients who did not wish to participate in the study were excluded
Trial locations and contacts
1 site in 1 country.
About this study
AIM: This prospective clinical study aimed to evaluate the efficacy of two distinct non-surgical periodontal therapy modalities in patients diagnosed with Stage 1 and Stage 2 periodontitis.
METHOD: The study comprised 80 nonsmoking, systemically healthy volunteers. Patients were divided into two groups at random: the Guided Biofilm Therapy (GBT) group and the convetional therapy group, which included Gracey curette and an ultrasonic device. All patients were assessed before and one and three months after therapy for clinical characteristics like pocket depth, Gingival Index (GI), Plaque Index (PI), Bleeding on Probing Index (BOP), and the levels of IL-1β, IL-10, TNF-α, and MMP-8 in gingival crevicular fluid (GCF).
RESULTS: ... CONCLUSION:...
Read the detailed description
AIM: This prospective clinical study aimed to evaluate the efficacy of two distinct non-surgical periodontal therapy modalities in patients diagnosed with Stage 1 and Stage 2 periodontitis.
METHOD: The study comprised 80 nonsmoking, systemically healthy volunteers. Patients were divided into two groups at random: the Guided Biofilm Therapy (GBT) group and the convetional therapy group, which included Gracey curette and an ultrasonic device. All patients were assessed before and one and three months after therapy for clinical characteristics like pocket depth, Gingival Index (GI), Plaque Index (PI), Bleeding on Probing Index (BOP), and the levels of IL-1β, IL-10, TNF-α, and MMP-8 in gingival crevicular fluid (GCF).
RESULTS: ... CONCLUSION:...
- Keywords
- periodontitis, guided biofilm therapy, non surgical periodontal treatment, Gingival Crevicular Fluid
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1.Group: The Conventional Treatment | Cavitron and Gracey curette (the standard technique) was utilized for subgingival debridement | |
| 2. group: Guided biofilm therapy | Subgingival debridement was carried out using the GBT approach, which involved following the protocol's directions properly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated.
0= Normal gingiva
- Mild inflammation - minor color change, minor edema. No bleeding after probing.
- Moderate inflammation - redness, edema and shine. Bleeding after probing.
- Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.
Measured: baseline
Gingival index
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated.
0= Normal gingiva
- Mild inflammation - minor color change, minor edema. No bleeding after probing.
- Moderate inflammation - redness, edema and shine. Bleeding after probing.
- Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.
Measured: 1st month
Gingival index
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated.
0= Normal gingiva
- Mild inflammation - minor color change, minor edema. No bleeding after probing.
- Moderate inflammation - redness, edema and shine. Bleeding after probing.
- Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.
Measured: 3rd month
IL-1β
A single specialist physician took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific).
As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF
Measured: baseline
IL-1β
A single specialist physician (SOB) took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific).
As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF
Measured: 1st month
IL-1β
A single specialist physician (SOB) took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific).
As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Oct 2024
- Primary completion15 Apr 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peridontal DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcen Ozcan Bulut
- Sponsor type
- University, hospital or other
- Collaborators
- Nigde Omer Halisdemir University, Niğde Ömer Halisdemir University
- Responsible party
- Sponsor-investigator, Selcen Ozcan Bulut, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243145
- Sponsor's protocol ID
- 2023/87
- Status last verified
- Nov 2025
- First submitted
- 29 May 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact of Contemporary Subgingival Debridement Techniques on Immunological Biomarkers in Gingival Crevicular Fluid
- ClinicalTrials.gov ID
- NCT07243145
- Acronym / sponsor ID
- 2023/87
- Keywords
- periodontitis, guided biofilm therapy, non surgical periodontal treatment, Gingival Crevicular Fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Selcen Ozcan BulutUniversity, hospital or other
- Collaborators
- Nigde Omer Halisdemir University, Niğde Ömer Halisdemir University
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 21 Nov 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.
AIM: This prospective clinical study aimed to evaluate the efficacy of two distinct non-surgical periodontal therapy modalities in patients diagnosed with Stage 1 and Stage 2 periodontitis.
METHOD: The study comprised 80 nonsmoking, systemically healthy volunteers. Patients were divided into two groups at random: the Guided Biofilm Therapy (GBT) group and the convetional therapy group, which included Gracey curette and an ultrasonic device. All patients were assessed before and one and three months after therapy for clinical characteristics like pocket depth, Gingival Index (GI), Plaque Index (PI), Bleeding on Probing Index (BOP), and the levels of IL-1β, IL-10, TNF-α, and MMP-8 in gingival crevicular fluid (GCF).
RESULTS: ... CONCLUSION:...
Detailed description
AIM: This prospective clinical study aimed to evaluate the efficacy of two distinct non-surgical periodontal therapy modalities in patients diagnosed with Stage 1 and Stage 2 periodontitis.
METHOD: The study comprised 80 nonsmoking, systemically healthy volunteers. Patients were divided into two groups at random: the Guided Biofilm Therapy (GBT) group and the convetional therapy group, which included Gracey curette and an ultrasonic device. All patients were assessed before and one and three months after therapy for clinical characteristics like pocket depth, Gingival Index (GI), Plaque Index (PI), Bleeding on Probing Index (BOP), and the levels of IL-1β, IL-10, TNF-α, and MMP-8 in gingival crevicular fluid (GCF).
RESULTS: ... CONCLUSION:...
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Group: The Conventional Treatment | – | –Cavitron and Gracey curette (the standard technique) was utilized for subgingival debridement |
| 2. group: Guided biofilm therapy | – | –Subgingival debridement was carried out using the GBT approach, which involved following the protocol's directions properly. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who applied to Niğde Ömer Halisdemir University Faculty of Dentistry Periodontics Clinic between 15.10.2024 and 15.12.2024 for periodontal treatment, volunteered to participate in the study and met the following criteria were included in the study. Written consent was obtained from volunteer patients for the research. The patients were evaluated by a single periodontologist (SND), and patients with mild to moderate periodontitis (Stage 1-2) who required supragingival and subgingival calculus removal were included in the study.
Key inclusion criteria (4 listed)
- Systemically healthy (no known chronic diseases)
- Completed periodontal diagnostic data (Gingival Index, Plaque Index, Periodontal pocket depths, Attachment loss, Radiological data, and Bone loss data)
- Did not take anti-inflammatory drugs in the previous month
- Volunteered to participate with Stage 1-2 periodontitis.
Key exclusion criteria (4 listed)
- Patients with systemic diseases
- Pregnant or lactating patients
- Smokers
- Patients who did not wish to participate in the study were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gingival index
Time frame: baseline
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva 1. Mild inflammation - minor color change, minor edema. No bleeding after probing. 2. Moderate inflammation - redness, edema and shine. Bleeding after probing. 3. Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.
Gingival index
Time frame: 1st month
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva 1. Mild inflammation - minor color change, minor edema. No bleeding after probing. 2. Moderate inflammation - redness, edema and shine. Bleeding after probing. 3. Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.
Gingival index
Time frame: 3rd month
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva 1. Mild inflammation - minor color change, minor edema. No bleeding after probing. 2. Moderate inflammation - redness, edema and shine. Bleeding after probing. 3. Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.
IL-1β
Time frame: baseline
A single specialist physician took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific). As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF
IL-1β
Time frame: 1st month
A single specialist physician (SOB) took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific). As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF
IL-1β
Time frame: 3rd month
A single specialist physician (SOB) took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific). As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF
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 21 Nov 2025.
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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?
An observational study of Peridontal Disease and Periodontal Inflammation, run by Selcen Ozcan Bulut 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 4 inclusion and 4 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 21 Nov 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?
Gingival index (time frame: baseline). The study lists 6 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 21 Nov 2025.