PeriodontitisNCT07788937
Effect of Guided Biofilm Therapy in Patients With Stage 3 Periodontitis
A study testing Non-Surgical Periodontal Therapy, Diode Laser Therapy and Guided Biofilm Therapy in people with Periodontitis and Periodontitis (Stage 3), run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This randomized interventional study aims to compare the clinical and biochemical effects of conventional non-surgical periodontal therapy (NSPT), adjunctive diode laser therapy, and guided biofilm therapy (GBT) in patients with Stage 3 periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Periodontitis (Stage 3)
- What is being tested?
- Non-Surgical Periodontal Therapy, Diode Laser Therapy and Guided Biofilm Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2023to 28 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Diagnosis of Stage III periodontitis with clinical attachment loss (CAL) ≥5 mm, probing pocket depth (PPD) ≥6 mm, and radiographic bone loss extending to the middle or apical third of the root.
- Systemically healthy individuals.
- Non-smokers and non-alcohol users.
- No periodontal treatment within the previous 6 months.
- No history of destructive periodontal disease.
- Not pregnant or breastfeeding.
- Written informed consent provided.
Who cannot join
- Age <18 years or >65 years.
- Periodontitis other than Stage III.
- Presence of systemic diseases affecting periodontal health.
- Current smokers or alcohol users.
- Periodontal treatment within the previous 6 months.
- History of destructive periodontal disease.
- Pregnancy or breastfeeding.
- Inability or unwillingness to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontology, Faculty of Dentistry, Ataturk University
Erzurum, 25240
About this study
Official title: The Effect of Guided Biofilm Therapy and Adjunctive Diode Laser on Periodontal Inflammation and Alveolar Bone Destruction in Patients With Stage 3 Periodontitis
This randomized interventional study aims to compare the clinical and biochemical effects of conventional non-surgical periodontal therapy (NSPT), adjunctive diode laser therapy, and guided biofilm therapy (GBT) in patients with Stage 3 periodontitis.
Participants are allocated to one of three treatment groups: conventional NSPT alone, NSPT combined with diode laser therapy, or NSPT combined with guided biofilm therapy. Clinical periodontal parameters, including plaque index, gingival index, probing pocket depth, clinical attachment level, and bleeding on probing, are evaluated before treatment and during follow-up. In addition, serum and gingival crevicular fluid samples are collected to determine the levels of inflammatory biomarkers, including IL-1β, IL-1 receptor antagonist (IL-1RA), sclerostin, and transforming growth factor-beta 1 (TGF-β1).
The study evaluates whether adjunctive treatment modalities provide additional clinical and biological benefits compared with conventional non-surgical periodontal therapy alone.
Read the detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of periodontal supporting tissues. Conventional non-surgical periodontal therapy (NSPT) is considered the standard treatment; however, adjunctive treatment approaches have been introduced to improve clinical outcomes and reduce inflammation.
Guided biofilm therapy (GBT) is a minimally invasive treatment protocol that combines biofilm visualization, air-polishing, and selective calculus removal. Diode laser therapy has also been proposed as an adjunctive treatment because of its antimicrobial, anti-inflammatory, and biostimulatory effects.
The purpose of this randomized clinical study is to compare the effects of conventional NSPT alone, NSPT combined with diode laser therapy, and NSPT combined with GBT in patients diagnosed with Stage 3 periodontitis.
Participants are randomly assigned to one of three parallel treatment groups. Clinical periodontal parameters are recorded at baseline and during follow-up. Gingival crevicular fluid and serum samples are collected for biochemical analysis. The concentrations of IL-1β, IL-1 receptor antagonist (IL-1RA), sclerostin, and transforming growth factor-beta 1 (TGF-β1) are measured using enzyme-linked immunosorbent assay (ELISA).
The primary objective is to compare the effects of the three treatment protocols on periodontal inflammation and clinical periodontal outcomes. Secondary objectives include evaluating changes in inflammatory biomarker levels in serum and gingival crevicular fluid and investigating the potential biological mechanisms associated with each treatment modality.
The findings of this study are expected to contribute to the evidence regarding adjunctive treatment approaches for Stage 3 periodontitis and improve understanding of the biological effects of guided biofilm therapy and diode laser therapy in periodontal treatment.
- Conditions
- Periodontitis, Periodontitis (Stage 3)
- Being tested
- Non-Surgical Periodontal Therapy, Diode Laser Therapy, Guided Biofilm Therapy
- Keywords
- Guided Biofilm Therapy, Non-Surgical Periodontal Therapy, Diode Laser
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal TherapyProcedure or surgery
Conventional non-surgical periodontal therapy consisting of full-mouth scaling and root planing performed using ultrasonic and hand instruments according to the study protocol.
Diode Laser TherapyProcedure or surgery
Adjunctive diode laser therapy administered following conventional non-surgical periodontal therapy according to the study protocol.
Guided Biofilm TherapyProcedure or surgery
Guided biofilm therapy performed using an erythritol powder air-polishing system as an adjunct to conventional non-surgical periodontal therapy according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Conventional NSPT | Active comparator | Participants received conventional non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing using ultrasonic and hand instruments. No adjunctive treatment was administered in this group. Clinical and biochemical outcomes were evaluated during the follow-up period. Receives: Procedure: Non-Surgical Periodontal Therapy |
| NSPT + Diode Laser | Experimental | Participants received conventional non-surgical periodontal therapy followed by adjunctive diode laser therapy according to the study protocol. Clinical periodontal parameters and inflammatory biomarkers were evaluated during follow-up. Receives: Procedure: Non-Surgical Periodontal Therapy; Procedure: Diode Laser Therapy |
| NSPT + Guided Biofilm Therapy | Experimental | Participants received conventional non-surgical periodontal therapy combined with guided biofilm therapy (GBT) using an air-polishing system according to the study protocol. Clinical periodontal parameters and inflammatory biomarkers were evaluated during follow-up. Receives: Procedure: Non-Surgical Periodontal Therapy; Procedure: Guided Biofilm Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Level (CAL)
Change in clinical attachment level (CAL, mm) from baseline to 3 months after treatment. CAL was measured using a periodontal probe at six sites per tooth.
Measured: Baseline and 3 months
Change in IL-1β Levels in Gingival Crevicular Fluid
Change in gingival crevicular fluid IL-1β concentrations measured by ELISA from baseline to 3 months.
Measured: Baseline and 3 months
Change in Probing Pocket Depth (PPD)
Change in probing pocket depth (PPD, mm) measured using a periodontal probe at six sites per tooth.
Measured: Baseline and 3 months
Change in Gingival Index (GI)
Change in gingival inflammation assessed using the Gingival Index (GI).
Measured: Baseline and 3 months
Change in Plaque Index (PI)
Change in dental plaque accumulation assessed using the Plaque Index (PI).
Measured: Baseline and 3 months
Change in Bleeding on Probing (BOP)
Change in bleeding on probing (BOP) assessed during periodontal examination.
Measured: Baseline and 3 months
Change in Gingival Crevicular Fluid IL-1 Receptor Antagonist (IL-1RA) Levels
Change in gingival crevicular fluid IL-1 receptor antagonist (IL-1RA) concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and 3 months
Change in Gingival Crevicular Fluid Sclerostin Levels
Change in gingival crevicular fluid sclerostin concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and 3 months
Change in Gingival Crevicular Fluid Transforming Growth Factor-β1 (TGF-β1) Levels
Change in gingival crevicular fluid transforming growth factor-beta 1 (TGF-β1) concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and 3 months
Change in Radiographic Alveolar Bone Level
Change in radiographic alveolar bone level assessed using standardized periapical radiographs.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start31 Aug 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
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.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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 were randomly assigned to one of three parallel treatment groups: conventional non-surgical periodontal therapy (NSPT) alone, NSPT combined with adjunctive diode laser therapy, or NSPT combined with guided biofilm therapy (GBT). Each participant received only one assigned intervention throughout the study, and outcomes were compared between the three parallel groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem OZKAL EMINOGLU, Ataturk University
- Investigators
- Didem Özkal Eminoğlu, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788937
- Sponsor's protocol ID
- TDK-2023-12443
- Other IDs
- ID: TDK-2023-12443
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article, including demographic characteristics, clinical periodontal measurements, radiographic measurements, and inflammatory biomarker data (IL-1β, IL-1 receptor antagonist \[IL-1RA\], sclerostin, and transforming growth factor-beta 1 \[TGF-β1\]), will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Biofilm Therapy and Adjunctive Diode Laser on Periodontal Inflammation and Alveolar Bone Destruction in Patients With Stage 3 Periodontitis
- ClinicalTrials.gov ID
- NCT07788937
- Acronym / sponsor ID
- TDK-2023-12443
- Conditions
- Periodontitis, Periodontitis (Stage 3)
- Keywords
- Guided Biofilm Therapy, Non-Surgical Periodontal Therapy, Diode Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 27 Aug 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 randomized interventional study aims to compare the clinical and biochemical effects of conventional non-surgical periodontal therapy (NSPT), adjunctive diode laser therapy, and guided biofilm therapy (GBT) in patients with Stage 3 periodontitis.
Participants are allocated to one of three treatment groups: conventional NSPT alone, NSPT combined with diode laser therapy, or NSPT combined with guided biofilm therapy. Clinical periodontal parameters, including plaque index, gingival index, probing pocket depth, clinical attachment level, and bleeding on probing, are evaluated before treatment and during follow-up. In addition, serum and gingival crevicular fluid samples are collected to determine the levels of inflammatory biomarkers, including IL-1β, IL-1 receptor antagonist (IL-1RA), sclerostin, and transforming growth factor-beta 1 (TGF-β1).
The study evaluates whether adjunctive treatment modalities provide additional clinical and biological benefits compared with conventional non-surgical periodontal therapy alone.
Detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of periodontal supporting tissues. Conventional non-surgical periodontal therapy (NSPT) is considered the standard treatment; however, adjunctive treatment approaches have been introduced to improve clinical outcomes and reduce inflammation.
Guided biofilm therapy (GBT) is a minimally invasive treatment protocol that combines biofilm visualization, air-polishing, and selective calculus removal. Diode laser therapy has also been proposed as an adjunctive treatment because of its antimicrobial, anti-inflammatory, and biostimulatory effects.
The purpose of this randomized clinical study is to compare the effects of conventional NSPT alone, NSPT combined with diode laser therapy, and NSPT combined with GBT in patients diagnosed with Stage 3 periodontitis.
Participants are randomly assigned to one of three parallel treatment groups. Clinical periodontal parameters are recorded at baseline and during follow-up. Gingival crevicular fluid and serum samples are collected for biochemical analysis. The concentrations of IL-1β, IL-1 receptor antagonist (IL-1RA), sclerostin, and transforming growth factor-beta 1 (TGF-β1) are measured using enzyme-linked immunosorbent assay (ELISA).
The primary objective is to compare the effects of the three treatment protocols on periodontal inflammation and clinical periodontal outcomes. Secondary objectives include evaluating changes in inflammatory biomarker levels in serum and gingival crevicular fluid and investigating the potential biological mechanisms associated with each treatment modality.
The findings of this study are expected to contribute to the evidence regarding adjunctive treatment approaches for Stage 3 periodontitis and improve understanding of the biological effects of guided biofilm therapy and diode laser therapy in periodontal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel treatment groups: conventional non-surgical periodontal therapy (NSPT) alone, NSPT combined with adjunctive diode laser therapy, or NSPT combined with guided biofilm therapy (GBT). Each participant received only one assigned intervention throughout the study, and outcomes were compared between the three parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Conventional NSPT | Active comparator | Procedure: Non-Surgical Periodontal TherapyParticipants received conventional non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing using ultrasonic and hand instruments. No adjunctive treatment was administered in this group. Clinical and biochemical outcomes were evaluated during the follow-up period. |
| NSPT + Diode Laser | Experimental | Procedure: Non-Surgical Periodontal Therapy, Procedure: Diode Laser TherapyParticipants received conventional non-surgical periodontal therapy followed by adjunctive diode laser therapy according to the study protocol. Clinical periodontal parameters and inflammatory biomarkers were evaluated during follow-up. |
| NSPT + Guided Biofilm Therapy | Experimental | Procedure: Non-Surgical Periodontal Therapy, Procedure: Guided Biofilm TherapyParticipants received conventional non-surgical periodontal therapy combined with guided biofilm therapy (GBT) using an air-polishing system according to the study protocol. Clinical periodontal parameters and inflammatory biomarkers were evaluated during follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 to 65 years.
- Diagnosis of Stage III periodontitis with clinical attachment loss (CAL) ≥5 mm, probing pocket depth (PPD) ≥6 mm, and radiographic bone loss extending to the middle or apical third of the root.
- Systemically healthy individuals.
- Non-smokers and non-alcohol users.
- No periodontal treatment within the previous 6 months.
Key exclusion criteria (8 listed)
- Age <18 years or >65 years.
- Periodontitis other than Stage III.
- Presence of systemic diseases affecting periodontal health.
- Current smokers or alcohol users.
- Periodontal treatment within the previous 6 months.
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 |
|---|---|---|
| Non-Surgical Periodontal TherapyConventional non-surgical periodontal therapy consisting of full-mouth scaling and root planing performed using ultrasonic and hand instruments according to the study protocol. | Procedure or surgery | Conventional NSPT, NSPT + Diode Laser, NSPT + Guided Biofilm Therapy |
| Diode Laser TherapyAdjunctive diode laser therapy administered following conventional non-surgical periodontal therapy according to the study protocol. | Procedure or surgery | NSPT + Diode Laser |
| Guided Biofilm TherapyGuided biofilm therapy performed using an erythritol powder air-polishing system as an adjunct to conventional non-surgical periodontal therapy according to the study protocol. | Procedure or surgery | NSPT + Guided Biofilm Therapy |
Primary outcome
Change in Clinical Attachment Level (CAL)
Time frame: Baseline and 3 months
Change in clinical attachment level (CAL, mm) from baseline to 3 months after treatment. CAL was measured using a periodontal probe at six sites per tooth.
Change in IL-1β Levels in Gingival Crevicular Fluid
Time frame: Baseline and 3 months
Change in gingival crevicular fluid IL-1β concentrations measured by ELISA from baseline to 3 months.
Change in Probing Pocket Depth (PPD)
Time frame: Baseline and 3 months
Change in probing pocket depth (PPD, mm) measured using a periodontal probe at six sites per tooth.
Change in Gingival Index (GI)
Time frame: Baseline and 3 months
Change in gingival inflammation assessed using the Gingival Index (GI).
Change in Plaque Index (PI)
Time frame: Baseline and 3 months
Change in dental plaque accumulation assessed using the Plaque Index (PI).
Change in Bleeding on Probing (BOP)
Time frame: Baseline and 3 months
Change in bleeding on probing (BOP) assessed during periodontal examination.
Change in Gingival Crevicular Fluid IL-1 Receptor Antagonist (IL-1RA) Levels
Time frame: Baseline and 3 months
Change in gingival crevicular fluid IL-1 receptor antagonist (IL-1RA) concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Change in Gingival Crevicular Fluid Sclerostin Levels
Time frame: Baseline and 3 months
Change in gingival crevicular fluid sclerostin concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Change in Gingival Crevicular Fluid Transforming Growth Factor-β1 (TGF-β1) Levels
Time frame: Baseline and 3 months
Change in gingival crevicular fluid transforming growth factor-beta 1 (TGF-β1) concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Change in Radiographic Alveolar Bone Level
Time frame: Baseline and 3 months
Change in radiographic alveolar bone level assessed using standardized periapical radiographs.
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 27 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article, including demographic characteristics, clinical periodontal measurements, radiographic measurements, and inflammatory biomarker data (IL-1β, IL-1 receptor antagonist [IL-1RA], sclerostin, and transforming growth factor-beta 1 [TGF-β1]), will be shared.
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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.
Didem Özkal Eminoğlu principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Therapy, Diode Laser Therapy and Guided Biofilm Therapy in people with Periodontitis and Periodontitis (Stage 3), run by Ataturk University 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 8 inclusion and 8 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 27 Aug 2026. 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 Clinical Attachment Level (CAL) (time frame: Baseline and 3 months). The study lists 10 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 27 Aug 2026.