PeriodontitisNCT07286916
Impact of Guided Biofilm Therapy on Epithelial and Mesenchymal Biomarkers in Periodontitis Patients
A study testing Root surface debridement and Guided Biofilm Therapy in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to investigate the clinical and biochemical effects of the guided biofilm therapy protocol as an alternative to the conventional non-surgical periodontal therapy in patients with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Root surface debridement and Guided Biofilm Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIraq
- Study dates
- 4 Jan 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (>18 years).
- Subjects are not currently under active periodontal therapy or joining other trial in the last 3 months.
- Patients must be diagnosed with generalized unstable periodontitis with bilateral, symmetrical distribution of PPD ≥ 4mm and positive BOP.
- -
Who cannot join
- Patients not diagnosed with periodontitis.
- Patients consuming antibiotics.
- Regular users of nonsteroidal anti-inflammatory drugs (NSAIDs).
- Patients receiving periodontal treatment 3-months prior to the study.
- Pregnant or mothers in a breastfeeding period.
- Third molars and teeth with furcation involvement.
Show all 10Show fewer
- Patients taking antioxidant supplements.
- Patients with heavy calculus that would prevent PerioPaper strips entrance to the periodontal pocket.
- Patient with pulmonary diseases and with a history of allergy to erythritol.
- Patients not willing to participate. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry, University of Baghdad
Baghdad, 10047
College of Dentistry, University of Baghdad, 0096414169394, master@codental.uobaghdad.edu.iq
About this study
Official title: Impact of Guided Biofilm Therapy on Gingival Crevicular Fluid Epithelial and Mesenchymal Biomarkers in Periodontitis Patients: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to investigate the clinical and biochemical effects of the guided biofilm therapy protocol as an alternative to the conventional non-surgical periodontal therapy in patients with periodontitis. The main question it aims to answer is:
Does the guided biofilm therapy (GBT) protocol have an impact on gingival crevicular fluid (GCF) epithelial and mesenchymal biomarkers in patients with periodontitis?
Read more
All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of toothpaste and toothbrush, with suitable interdental aids. All patients will be instructed to attend again after 7 days.
At baseline, full-mouth periodontal charting and radiographs will be obtained and after 1-hour, GCF samples will be collected from both test and control groups. Sites allocated to control group will undergo supragingival debridement by using ultrasonic device. After one week, the control group will receive RSD using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol and will receive teeth polishing by using rubber polishing cups and tooth polishing paste, while the test group will receive a full GBT protocol which includes eight steps: (1) ASSESS, (2) DISCLOSE, (3) MOTIVATE, (4) AIRFLOW, (5) PERIOFLOW, (6) PIEZON PS*, (7) CHECK, and (8) RECALL. After finishing the treatment session, the patients will be asked to attend for follow up, clinical evaluation of PI, BOP, PPD, and CAL, and GCF samples collection after 1 month and 3 months.
- Conditions
- Periodontitis
- Being tested
- Root surface debridement, Guided Biofilm Therapy
- Keywords
- Guided biofilm therapy, Gingival crevicular fluid, Epithelial Mesenchymal Transition, Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root surface debridementProcedure or surgery
Control group sites that will receive conventional NSPT will undergo supragingival debridement by using ultrasonic device at baseline. After one week, sites will receive root surface debridement (RSD) using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol.
Guided Biofilm TherapyDevice
Test group sites will receive guided biofilm therapy (GBT) protocol using the Airflow Prophylaxis Master device by EMS which includes EMS DISCLOSING AGENT making the biofilm visible, EMS AIRFLOW combined with PLUS erythritol powder for removing biofilm, discoloration, and early calculus, PERIOFLOW removing the biofilm in deep periodontal pockets gently and thoroughly, and finally PIEZON PS for removing the remaining calculus.
| Study group | Role | What they receive |
|---|---|---|
| Conventional non-surgical periodontal therapy (NSPT) | Active comparator | Control group Receives: Procedure: Root surface debridement |
| Guided Biofilm Therapy (GBT) | Experimental | Test group Receives: Device: Guided Biofilm Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing pocket depth (PPD)
After treatment completion PPD ≤4mm with no BOP at 4mm pockets
Measured: 3 months
Secondary outcomes (4)
Clinical attachment level (CAL)
Measured: 3 months
Bleeding on probing (BOP)
Measured: 3 months
Plaque index (PI)
Measured: 3 months
Levels of gingival crevicular fluid (GCF) biomarkers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start4 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
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 University of BaghdadThe 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
- The study is a 2 arm, split-mouth, double blinded, randomized clinical trial. The first group is control group will receive conventional NSPT (scaling \& root surface debridement (RSD)), while the second group is the test group will be treated according to the GBT protocol.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Haider Sadeq, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286916
- Sponsor's protocol ID
- 1108625
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Guided Biofilm Therapy on Gingival Crevicular Fluid Epithelial and Mesenchymal Biomarkers in Periodontitis Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07286916
- Acronym / sponsor ID
- 1108625
- Conditions
- Periodontitis
- Keywords
- Guided biofilm therapy, Gingival crevicular fluid, Epithelial Mesenchymal Transition, Periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 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.
The goal of this clinical trial is to investigate the clinical and biochemical effects of the guided biofilm therapy protocol as an alternative to the conventional non-surgical periodontal therapy in patients with periodontitis. The main question it aims to answer is:
Does the guided biofilm therapy (GBT) protocol have an impact on gingival crevicular fluid (GCF) epithelial and mesenchymal biomarkers in patients with periodontitis?
All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of toothpaste and toothbrush, with suitable interdental aids. All patients will be instructed to attend again after 7 days.
At baseline, full-mouth periodontal charting and radiographs will be obtained and after 1-hour, GCF samples will be collected from both test and control groups. Sites allocated to control group will undergo supragingival debridement by using ultrasonic device. After one week, the control group will receive RSD using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol and will receive teeth polishing by using rubber polishing cups and tooth polishing paste, while the test group will receive a full GBT protocol which includes eight steps: (1) ASSESS, (2) DISCLOSE, (3) MOTIVATE, (4) AIRFLOW, (5) PERIOFLOW, (6) PIEZON PS*, (7) CHECK, and (8) RECALL. After finishing the treatment session, the patients will be asked to attend for follow up, clinical evaluation of PI, BOP, PPD, and CAL, and GCF samples collection after 1 month and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a 2 arm, split-mouth, double blinded, randomized clinical trial. The first group is control group will receive conventional NSPT (scaling \& root surface debridement (RSD)), while the second group is the test group will be treated according to the GBT protocol.
| Arm | Type | Receives |
|---|---|---|
| Conventional non-surgical periodontal therapy (NSPT) | Active comparator | Procedure: Root surface debridementControl group |
| Guided Biofilm Therapy (GBT) | Experimental | Device: Guided Biofilm TherapyTest group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects (>18 years).
- Subjects are not currently under active periodontal therapy or joining other trial in the last 3 months.
- Patients must be diagnosed with generalized unstable periodontitis with bilateral, symmetrical distribution of PPD ≥ 4mm and positive BOP.
- -
Key exclusion criteria (10 listed)
- Patients not diagnosed with periodontitis.
- Patients consuming antibiotics.
- Regular users of nonsteroidal anti-inflammatory drugs (NSAIDs).
- Patients receiving periodontal treatment 3-months prior to the study.
- Pregnant or mothers in a breastfeeding period.
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 |
|---|---|---|
| Root surface debridementControl group sites that will receive conventional NSPT will undergo supragingival debridement by using ultrasonic device at baseline. After one week, sites will receive root surface debridement (RSD) using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol. | Procedure or surgery | Conventional non-surgical periodontal therapy (NSPT) |
| Guided Biofilm TherapyTest group sites will receive guided biofilm therapy (GBT) protocol using the Airflow Prophylaxis Master device by EMS which includes EMS DISCLOSING AGENT making the biofilm visible, EMS AIRFLOW combined with PLUS erythritol powder for removing biofilm, discoloration, and early calculus, PERIOFLOW removing the biofilm in deep periodontal pockets gently and thoroughly, and finally PIEZON PS for removing the remaining calculus. | Device | Guided Biofilm Therapy (GBT) |
Primary outcome
Change in probing pocket depth (PPD)
Time frame: 3 months
After treatment completion PPD ≤4mm with no BOP at 4mm pockets
4 secondary outcomes
Clinical attachment level (CAL)
Time frame: 3 months
Bleeding on probing (BOP)
Time frame: 3 months
Plaque index (PI)
Time frame: 3 months
Levels of gingival crevicular fluid (GCF) biomarkers
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root surface debridement and Guided Biofilm Therapy in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
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 10 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Haider Sadeq, B.D.S (009647722247642, Ibrahim.Ata2405@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in probing pocket depth (PPD) (time frame: 3 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 27 Feb 2026.