PeriodontitisPhase 4NCT07707063
This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients
A Phase 4 study testing Injectable Platelet-Rich Fibrin (I-PRF), Diode Laser Activation and Povidone-Iodine Irrigation (1%) in people with Periodontitis and Smokers, run by Military Hospital of Tunis at 1 site in Tunisia.
Trial summary
This study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP). This protocol is designed to be a standardized therapeutic model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Smokers, Non Smokers
- What is being tested?
- Injectable Platelet-Rich Fibrin (I-PRF), Diode Laser Activation and Povidone-Iodine Irrigation (1%)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 25 May 2026to 18 May 2027
- Phase
- Phase 4
- 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
None listed.
Who cannot join
- Pregnant /Lactating
- History of radiotherapy or chemotherapy in the head/neck region.
- Known hypersensitivity to Iodine or Methylene blue solution
- Systematic antibiotic use within the last 30 days
- Long-term use of immunosuppressants or corticosteroids (daily use)
- type 1 / 2 diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Military Hospital of Instruction of Tunis
Tunis, Mont Fleury, 1008
hela Jegham, DDS - Professor, +216 54 241 521, hela.jegham@yahoo.fr
hedi chouchene, DDS
About this study
Official title: Clinical Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients : A Split Mouth Randomized Clinical Trial
This study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP). This protocol is designed to be a standardized therapeutic model. The subgingival adjuncts are standardized, ensuring that the results are not operator dependent and can be replicated across any dental unit. The primary goal of this study is to evaluate the clinical efficacy of three distinct adjunctive strategies: Biological (I-PRF), Antiseptic : Povidone- iodine , Diode-Laser activation, compared to a Saline Control in the initial treatment of stage 2, 3 and stage 4 of the 2018 AAP/EFP periodontal classification.
Read the detailed description
The investigators hypothesize that while all adjuncts will improve results over SRP and saline irrigation , the biological group (I-PRF) will show the most significant gains in the Smoker Subgroup due to its ability to stimulate local angiogenesis and tissue repair in a traditionally poor healing environment.
- By including smokers, this study addresses "the down to reality " challenge in dentistry. Smoking often impairs the blood supply to the gums; this trial investigates: if a biological approach like I-PRF (which introduces fresh growth factors) or a high-volume Antiseptic irrigation with Povidone-iodine, or a 980nm diode laser activation can overcome these healing barriers . The Key Research Goals: is to determine if the Biological group (I-PRF), which introduces high concentrations of growth factors and leukocytes, provides superior Probing Pocket Depth (PPD) reduction compared to an antiseptic group (Povidone-Iodine) and photobiomodulation group (diode laser activation).
- The Smoking Factor:
Investigator will explore if the regenerative properties of I-PRF can overcome the compromised healing response typically found in the Smoking Subgroup.
- Healing Quality: Investigator will identify which group shows the fastest reduction in inflammation, measured by Bleeding on Probing (BOP) and Clinical Attachment Level (CAL) gain.
- Conditions
- Periodontitis, Smokers, Non Smokers, Periodontal Disease
- Being tested
- Injectable Platelet-Rich Fibrin (I-PRF), Diode Laser Activation, Povidone-Iodine Irrigation (1%), Saline Irrigation (0.9%), Scaling and Root Planing
- Keywords
- Injectable platelet-rich fibrin (I-PRF), Diode Laser, iodine solution, Periodontal Pockets, periodontal debridement, lasers, Regenerative periodontal therapy
- Medical subject headings
- Periodontitis, Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Platelet-Rich Fibrin (I-PRF)Biological
Following scaling and root planing, periodontal pockets in the assigned quadrant will receive 5 mL of injectable platelet-rich fibrin (I-PRF) prepared at 60 G for 3 minutes
Diode Laser ActivationDevice
Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol
Povidone-Iodine Irrigation (1%)Drug
Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of 1% povidone iodine solution delivered using a blunt-tip cannula.
Saline Irrigation (0.9%)Procedure or surgery
Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of sterile 0.9% saline solution delivered using a blunt-tip cannula. This intervention serves as the control treatment for comparison with the adjunctive therapies.
Scaling and Root PlaningProcedure or surgery
Conventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments. All study quadrants will receive SRP before adjunctive treatment allocation.
| Study group | Role | What they receive |
|---|---|---|
| I-PRF | Experimental | Quadrants randomly assigned to receive I-PRF irrigation after SRP Receives: Biological: Injectable Platelet-Rich Fibrin (I-PRF); Procedure: Scaling and Root Planing |
| Povidone-Iodine | Experimental | Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP Receives: Drug: Povidone-Iodine Irrigation (1%); Procedure: Scaling and Root Planing |
| Diode Laser | Experimental | Quadrants randomly assigned to receive diode laser activation after SRP Receives: Device: Diode Laser Activation; Procedure: Scaling and Root Planing |
| Saline Control | Sham comparator | Quadrants randomly assigned to receive 0.9% saline irrigation after SRP Receives: Procedure: Saline Irrigation (0.9%); Procedure: Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing (BOP)
Bleeding on Probing (BOP) will be assessed within 15 seconds after gentle probing at six sites per tooth using a calibrated periodontal probe ( The instrument used (UNC-15 periodontal probe). The presence or absence of bleeding will be recorded and expressed as the percentage of bleeding sites per treatment quadrant. Measurements will be obtained by a blinded examiner at baseline, 3 months, and 6 months
Measured: Baseline, 3 months, and 6 months
Probing Pocket Depth (PPD)
Probing Pocket Depth (PPD) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual/palatal, midlingual/palatal, and distolingual/palatal). Measurements will be performed by a calibrated examiner blinded to treatment allocation at baseline, 3 months, and 6 months.
Measured: Baseline, 3 months, and 6 months
Clinical Attachment Level (CAL)
Clinical Attachment Level (CAL) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth by measuring the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. Assessments will be performed by a blinded calibrated examiner at baseline, 3 months, and 6 months.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start25 May 2026
- Primary completion18 May 2027 (estimated)
- Study completion18 May 2027 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hela Jegham, Military Hospital of Tunis
- Investigators
- Hela Jegham, DDS -Professor, Study director, Military Hospital of Instruction of Tunishedi chouchene, DDS, Principal investigator, Military Hospital of Instruction of TunisRym masmoudi, DDS - Associate Professor, Study director, Military Hospital of Instruction of Tunisyassmine rjeb, DDS, Principal investigator, Military Hospital of Instruction of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707063
- Sponsor's protocol ID
- MilitaryHosp Tunis
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: identified individual participant data collected during the study will be shared, including demographic characteristics (age and sex), smoking status, baseline and follow-up periodontal measurements, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), treatment allocation by quadrant, and outcome data used in the primary and secondary analyses.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients : A Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07707063
- Acronym / sponsor ID
- MilitaryHosp Tunis
- Conditions
- Periodontitis, Smokers, Non Smokers, Periodontal Disease
- Keywords
- Injectable platelet-rich fibrin (I-PRF), Diode Laser, iodine solution, Periodontal Pockets, periodontal debridement, lasers, Regenerative periodontal therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 18 May 2027 (estimated)
- First posted
- 16 Jul 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 study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP). This protocol is designed to be a standardized therapeutic model. The subgingival adjuncts are standardized, ensuring that the results are not operator dependent and can be replicated across any dental unit. The primary goal of this study is to evaluate the clinical efficacy of three distinct adjunctive strategies: Biological (I-PRF), Antiseptic : Povidone- iodine , Diode-Laser activation, compared to a Saline Control in the initial treatment of stage 2, 3 and stage 4 of the 2018 AAP/EFP periodontal classification.
Detailed description
The investigators hypothesize that while all adjuncts will improve results over SRP and saline irrigation , the biological group (I-PRF) will show the most significant gains in the Smoker Subgroup due to its ability to stimulate local angiogenesis and tissue repair in a traditionally poor healing environment.
- By including smokers, this study addresses "the down to reality " challenge in dentistry. Smoking often impairs the blood supply to the gums; this trial investigates: if a biological approach like I-PRF (which introduces fresh growth factors) or a high-volume Antiseptic irrigation with Povidone-iodine, or a 980nm diode laser activation can overcome these healing barriers . The Key Research Goals: is to determine if the Biological group (I-PRF), which introduces high concentrations of growth factors and leukocytes, provides superior Probing Pocket Depth (PPD) reduction compared to an antiseptic group (Povidone-Iodine) and photobiomodulation group (diode laser activation).
- The Smoking Factor:
Investigator will explore if the regenerative properties of I-PRF can overcome the compromised healing response typically found in the Smoking Subgroup.
- Healing Quality: Investigator will identify which group shows the fastest reduction in inflammation, measured by Bleeding on Probing (BOP) and Clinical Attachment Level (CAL) gain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I-PRF | Experimental | Biological: Injectable Platelet-Rich Fibrin (I-PRF), Procedure: Scaling and Root PlaningQuadrants randomly assigned to receive I-PRF irrigation after SRP |
| Povidone-Iodine | Experimental | Drug: Povidone-Iodine Irrigation (1%), Procedure: Scaling and Root PlaningQuadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP |
| Diode Laser | Experimental | Device: Diode Laser Activation, Procedure: Scaling and Root PlaningQuadrants randomly assigned to receive diode laser activation after SRP |
| Saline Control | Sham comparator | Procedure: Saline Irrigation (0.9%), Procedure: Scaling and Root PlaningQuadrants randomly assigned to receive 0.9% saline irrigation after SRP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Pregnant /Lactating
- History of radiotherapy or chemotherapy in the head/neck region.
- Known hypersensitivity to Iodine or Methylene blue solution
- Systematic antibiotic use within the last 30 days
- Long-term use of immunosuppressants or corticosteroids (daily use)
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 |
|---|---|---|
| Injectable Platelet-Rich Fibrin (I-PRF)Following scaling and root planing, periodontal pockets in the assigned quadrant will receive 5 mL of injectable platelet-rich fibrin (I-PRF) prepared at 60 G for 3 minutes | Biological | I-PRF |
| Diode Laser ActivationFollowing scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol | Device | Diode Laser |
| Povidone-Iodine Irrigation (1%)Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of 1% povidone iodine solution delivered using a blunt-tip cannula. | Drug | Povidone-Iodine |
| Saline Irrigation (0.9%)Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of sterile 0.9% saline solution delivered using a blunt-tip cannula. This intervention serves as the control treatment for comparison with the adjunctive therapies. | Procedure or surgery | Saline Control |
| Scaling and Root PlaningConventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments. All study quadrants will receive SRP before adjunctive treatment allocation. | Procedure or surgery | Diode Laser, I-PRF, Povidone-Iodine, Saline Control |
Primary outcome
Bleeding on Probing (BOP)
Time frame: Baseline, 3 months, and 6 months
Bleeding on Probing (BOP) will be assessed within 15 seconds after gentle probing at six sites per tooth using a calibrated periodontal probe ( The instrument used (UNC-15 periodontal probe). The presence or absence of bleeding will be recorded and expressed as the percentage of bleeding sites per treatment quadrant. Measurements will be obtained by a blinded examiner at baseline, 3 months, and 6 months
Probing Pocket Depth (PPD)
Time frame: Baseline, 3 months, and 6 months
Probing Pocket Depth (PPD) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual/palatal, midlingual/palatal, and distolingual/palatal). Measurements will be performed by a calibrated examiner blinded to treatment allocation at baseline, 3 months, and 6 months.
Clinical Attachment Level (CAL)
Time frame: Baseline, 3 months, and 6 months
Clinical Attachment Level (CAL) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth by measuring the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. Assessments will be performed by a blinded calibrated examiner at baseline, 3 months, and 6 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 16 Jul 2026.
- Individual participant dataSharing planned: Yes. identified individual participant data collected during the study will be shared, including demographic characteristics (age and sex), smoking status, baseline and follow-up periodontal measurements, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), treatment allocation by quadrant, and outcome data used in the primary and secondary analyses.
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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.
Hela Jegham, DDS -Professor study director
Military Hospital of Instruction of Tunis
hedi chouchene, DDS principal investigator
Military Hospital of Instruction of Tunis
Rym masmoudi, DDS - Associate Professor study director
Military Hospital of Instruction of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Injectable Platelet-Rich Fibrin (I-PRF), Diode Laser Activation and Povidone-Iodine Irrigation (1%) in people with Periodontitis and Smokers, run by Military Hospital of Tunis at 1 site in Tunisia.
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 0 inclusion and 6 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 16 Jul 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 Tunisia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hela Jegham, DDS - Professor (+21654241521, hela.jegham@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on Probing (BOP) (time frame: Baseline, 3 months, and 6 months). The study lists 3 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 16 Jul 2026.