Stage III PeriodontitisPhase 1/2NCT07859358

Injectable Platelet-Rich Fibrin (i-PRF) and Oxygen-Releasing Gel in the Treatment of Stage II Periodontitis.

A Phase 1/2 study testing Injectable Platelet-Rich Fibrin (i-PRF, Peroxoborate Oxygen-Releasing Oral Gel and Sterile 0.9% Saline Solution in people with Stage III Periodontitis, run by Assiut University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Stage III Periodontitis
What is being tested?: Injectable Platelet-Rich Fibrin (i-PRF, Peroxoborate Oxygen-Releasing Oral Gel and Sterile 0.9% Saline Solution
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 2 sitesEgypt
Study dates: 20 Jan 2026to 10 Jul 2026
Phase: Phase 1/2
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with PPD ≤5 mm and clinical attachment loss of 3-4 mm grade A;
Presence of 2 walled or 3 walled infra-bony defects posterior segments;
Evidence of ≥3 mm of intra-bony defect depth evaluated by the visualization of peri-apical radiographs.

Who cannot join

Patients requiring antibiotic prophylaxis before the periodontal examination;
Patients diagnosed with malocclusion at the site of the defect;
Patients with systemic disease and/or on drugs that contraindicate periodontal surgery;
Patients with a history of smoking and pan chewing;

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

faculty of dentistry Assiut University
Asyut, 47471
faculty of dentistry Assiut University
Asyut

Other trials in Egypt

About this study

Official title: Comparative Efficacy of Injectable Platelet-Rich Fibrin (i-PRF) and Oxygen-Releasing Gel as Adjuncts to Non-Surgical Therapy in Stage II Periodontitis: A Randomized Clinical Trial.

Periodontitis is a chronic multifactorial inflammatory disorder affecting the periodontium, often implicated with microbial dysbiosis. Following the establishment of a proper diagnosis, the initial therapeutic phase within the recommended protocol must focus patient motivation and behavior alongside the comprehensive management of modifiable local and systemic risk factors. Although SRP effectively reduces microbial load, complete regeneration of periodontal tissues remains challenging due to limited healing potential and persistent inflammation. Various adjunctive therapies have been explored to enhance periodontal healing, including oxygen-based and platelet concentrate approaches.

Topical oxygen therapy has recently gained attention for its antimicrobial and regenerative properties. Oxygen-releasing gels, such as those containing stabilized hydrogen peroxide, increase local oxygen tension, inhibit anaerobic pathogens, and promote angiogenesis and fibroblast proliferation, resulting in improved clinical parameters following SRP.

Injectable platelet-rich fibrin (i-PRF), a second-generation autologous platelet concentrate, provides a sustained release of growth factors such as PDGF, VEGF, and TGF-β, enhancing soft tissue healing and bone regeneration. Clinical trials have demonstrated that i-PRF used with SRP significantly improves probing depth reduction, attachment gain, and bleeding scores compared with SRP alone. However, no studies have directly compared oxygen therapy and i-PRF as adjuncts to non-surgical periodontal therapy. Investigating these two bio stimulatory approaches could identify a minimally invasive, cost-effective strategy to optimize periodontal healing and regeneration.

Conditions: Stage III Periodontitis
Being tested: Injectable Platelet-Rich Fibrin (i-PRF, Peroxoborate Oxygen-Releasing Oral Gel, Sterile 0.9% Saline Solution, Scaling and Root Planing (SRP), Custom Acrylic Probing Sten
Medical subject headings: Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Injectable Platelet-Rich Fibrin (i-PRFBiological
Autologous injectable platelet-rich fibrin prepared chairside from 10 mL patient venous blood collected in plain plastic tubes without anticoagulant. Blood centrifuged at 700 rpm (60g) for 3 minutes using fixed-angle centrifuge at room temperature. Supernatant liquid fraction (upper 4-5 mL, yellowish) collected via 3 mL syringe with 27G needle. Immediately injected subgingivally (1-2 mL per site) through custom acrylic stent notches targeting sites with CAL ≥4 mm and PPD ≥5 mm. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications). Contains PDGF-BB, TGF-β1, VEGF, IGF-1, and viable leukocytes for sustained regenerative effect over 7-10 days.
Peroxoborate Oxygen-Releasing Oral GelDrug
Stabilized peroxoborate/peroxide-based oxygen-releasing dental gel (5-10% active oxygen equivalent, neutral pH 6.8-7.2). Applied via 3 mL blunt-tip syringe (27G) through acrylic stent notches (1-2 mL per site) to fill CAL ≥4 mm, PPD ≥5 mm periodontal pockets completely. Provides continuous oxygen release (O2 + reactive oxygen species) for 24-48 hours, creating anaerobic microenvironment disruption, bacterial kill, and enhanced tissue oxygenation. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications). Excess gel expressed from pocket orifice confirms complete filling
Sterile 0.9% Saline SolutionOther
Pharmaceutical-grade sterile 0.9% sodium chloride irrigation solution (pH 5.0-7.0, preservative-free). Identical 3 mL syringe delivery through 27G needle and acrylic stent as active arms (1-2 mL per site). Volume/color matches i-PRF; injection technique mimics biologic viscosity. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications) to maintain blinding. Provides sham subgingival irrigation without therapeutic effect, standardizing procedure across all arms
Scaling and Root Planing (SRP)Procedure or surgery
Full-mouth non-surgical periodontal debridement performed in 2 sessions (45-60 min each, 1-week interval). Supragingival/subgingival scaling using ultrasonic scaler (Cavitron, 30K Hz) + hand instruments (Gracey curettes 11/12, 13/14, universal 7/8). Root planning to remove cementum-embedded calculus and bacterial toxins from root surfaces. Sites with PPD ≥5 mm receive special attention. Local anesthesia (2% lidocaine 1:100K epi) as needed. Post-SRP oral hygiene instructions: modified Bass brushing technique (2x daily), interdental brushes/floss
Custom Acrylic Probing StenDevice
Individually fabricated acrylic stent (2-3 mm thick) from alginate impression of maxillary/mandibular study teeth. Vertical grooves/notches (2 mm deep) cut at mesio-buccal, mid-buccal, disto-buccal sites using #15C scalpel on stone cast. Trimmed/polished for patient comfort while maintaining reference points. Serves as fixed coronal landmark for UNC-15 probe insertion during CAL/PPD measurements at baseline, weeks 4, 8, 12. Ensures measurement reproducibility (±0.5 mm) across examiners/timepoints. Autoclaved between visits.

Study groups in NCT07859358
Study group	Role	What they receive
i-PRF Adjunctive Therapy	Experimental	Not described Receives: Biological: Injectable Platelet-Rich Fibrin (i-PRF; Other: Sterile 0.9% Saline Solution; Procedure: Scaling and Root Planing (SRP); Device: Custom Acrylic Probing Sten
Oxygen-Releasing Gel Therapy	Active comparator	Not described Receives: Drug: Peroxoborate Oxygen-Releasing Oral Gel; Other: Sterile 0.9% Saline Solution; Procedure: Scaling and Root Planing (SRP); Device: Custom Acrylic Probing Sten
Placebo Control	Placebo comparator	Not described Receives: Other: Sterile 0.9% Saline Solution; Procedure: Scaling and Root Planing (SRP); Device: Custom Acrylic Probing Sten

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Clinical Attachment Level (CAL)
Difference in CAL (mm) measured from custom acrylic stent reference point to base of periodontal pocket using UNC-15 periodontal probe at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) in sites with baseline CAL ≥5 mm. Primary endpoint: Week 12 CAL gain
Measured: Baseline, Weeks 4, 8, 12
Change in Probing Pocket Depth (PPD)
Difference in PPD (mm) from gingival margin to pocket base via UNC-15 probe through stent notches. Primary endpoint: Week 12 PPD reduction.
Measured: Baseline, Weeks 4, 8, 12
Bleeding on Probing (BOP)
Percentage of sites exhibiting bleeding within 30 seconds of gentle probing (presence/absence recorded).
Measured: Baseline, Weeks 4, 8, 12

Secondary outcomes (2)

Radiographic Bone Fill
Vertical bone level change (mm) measured on standardized digital periapical radiographs using image analysis software (vertical byte-wing technique, paralleling technique)
Measured: Baseline to Week 12
Gingival Index (GI)
Gingival inflammation scored at 6 sites per tooth using Löe \& Silness Gingival Index (0 = normal; 1 = mild inflammation; 2 = moderate inflammation; 3 = severe inflammation). Mean GI score per patient calculated from study sites (CAL ≥5 mm). Quantitative (Mean GI score 0-3)
Measured: Baseline, Weeks 4, 8, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 202610 Jul 2026

First posted5 Oct 2026
Study start20 Jan 2026
Primary completion20 Apr 2026
Study completion10 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Stage III PeriodontitisStudies of the same condition, open and under way.
More trials run by Assiut 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07859358
Sponsor's protocol ID: iPRF and Oxygen gel in pocket
Status last verified: Jan 2026
First submitted: 30 Sep 2026
Last updated: 6 Nov 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Vučković M, Nikolić N, Milašin J, Đorđević V, Milinković I, Asotić J, et al. The effect of injectable platelet-rich fibrin use in the initial treatment of chronic periodontitis. Srp Arh Celok Lek. 2020;148(5-6):280-5.
Singh A, Vasudevan S, Palle AR, Atchuta A, Bhadauriya S. Comparative Evaluation of Scaling and Root Planing with and without Oxygen-releasing Gel in the Treatment of Chronic Periodontitis: A Split-mouth Study. J Contemp Dent Pract. 2024 May 1;25(5):445-452. doi: 10.5005/jp-journals-10024-3689.
PubMed 39364843
Genco RJ. Current view of risk factors for periodontal diseases. J Periodontol. 1996 Oct;67(10 Suppl):1041-9. doi: 10.1902/jop.1996.67.10.1041.
PubMed 8910821
Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
PubMed 32383274

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP.
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Active, not recruitingObservational study
Evaluation of the Effect of Smoking on Apelin, Periostin, and High-Sensitivity CRP Levels in Gingival Crevicular Fluid and Serum
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All Stage III Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Efficacy of Injectable Platelet-Rich Fibrin (i-PRF) and Oxygen-Releasing Gel as Adjuncts to Non-Surgical Therapy in Stage II Periodontitis: A Randomized Clinical Trial.
ClinicalTrials.gov ID: NCT07859358
Acronym / sponsor ID: iPRF and Oxygen gel in pocket
Conditions: Stage III Periodontitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 20 Jan 2026 (actual)
Primary completion: 20 Apr 2026 (actual)
Study completion: 10 Jul 2026 (actual)
First posted: 5 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
i-PRF Adjunctive Therapy	Experimental	Biological: Injectable Platelet-Rich Fibrin (i-PRF, Other: Sterile 0.9% Saline Solution, Procedure: Scaling and Root Planing (SRP), Device: Custom Acrylic Probing Sten
Oxygen-Releasing Gel Therapy	Active comparator	Drug: Peroxoborate Oxygen-Releasing Oral Gel, Other: Sterile 0.9% Saline Solution, Procedure: Scaling and Root Planing (SRP), Device: Custom Acrylic Probing Sten
Placebo Control	Placebo comparator	Other: Sterile 0.9% Saline Solution, Procedure: Scaling and Root Planing (SRP), Device: Custom Acrylic Probing Sten

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Key exclusion criteria (4 listed)

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-PRFAutologous injectable platelet-rich fibrin prepared chairside from 10 mL patient venous blood collected in plain plastic tubes without anticoagulant. Blood centrifuged at 700 rpm (60g) for 3 minutes using fixed-angle centrifuge at room temperature. Supernatant liquid fraction (upper 4-5 mL, yellowish) collected via 3 mL syringe with 27G needle. Immediately injected subgingivally (1-2 mL per site) through custom acrylic stent notches targeting sites with CAL ≥4 mm and PPD ≥5 mm. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications). Contains PDGF-BB, TGF-β1, VEGF, IGF-1, and viable leukocytes for sustained regenerative effect over 7-10 days.	Biological	i-PRF Adjunctive Therapy
Peroxoborate Oxygen-Releasing Oral GelStabilized peroxoborate/peroxide-based oxygen-releasing dental gel (5-10% active oxygen equivalent, neutral pH 6.8-7.2). Applied via 3 mL blunt-tip syringe (27G) through acrylic stent notches (1-2 mL per site) to fill CAL ≥4 mm, PPD ≥5 mm periodontal pockets completely. Provides continuous oxygen release (O2 + reactive oxygen species) for 24-48 hours, creating anaerobic microenvironment disruption, bacterial kill, and enhanced tissue oxygenation. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications). Excess gel expressed from pocket orifice confirms complete filling	Drug	Oxygen-Releasing Gel Therapy
Sterile 0.9% Saline SolutionPharmaceutical-grade sterile 0.9% sodium chloride irrigation solution (pH 5.0-7.0, preservative-free). Identical 3 mL syringe delivery through 27G needle and acrylic stent as active arms (1-2 mL per site). Volume/color matches i-PRF; injection technique mimics biologic viscosity. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications) to maintain blinding. Provides sham subgingival irrigation without therapeutic effect, standardizing procedure across all arms	Other	Oxygen-Releasing Gel Therapy, Placebo Control, i-PRF Adjunctive Therapy
Scaling and Root Planing (SRP)Full-mouth non-surgical periodontal debridement performed in 2 sessions (45-60 min each, 1-week interval). Supragingival/subgingival scaling using ultrasonic scaler (Cavitron, 30K Hz) + hand instruments (Gracey curettes 11/12, 13/14, universal 7/8). Root planning to remove cementum-embedded calculus and bacterial toxins from root surfaces. Sites with PPD ≥5 mm receive special attention. Local anesthesia (2% lidocaine 1:100K epi) as needed. Post-SRP oral hygiene instructions: modified Bass brushing technique (2x daily), interdental brushes/floss	Procedure or surgery	Oxygen-Releasing Gel Therapy, Placebo Control, i-PRF Adjunctive Therapy
Custom Acrylic Probing StenIndividually fabricated acrylic stent (2-3 mm thick) from alginate impression of maxillary/mandibular study teeth. Vertical grooves/notches (2 mm deep) cut at mesio-buccal, mid-buccal, disto-buccal sites using #15C scalpel on stone cast. Trimmed/polished for patient comfort while maintaining reference points. Serves as fixed coronal landmark for UNC-15 probe insertion during CAL/PPD measurements at baseline, weeks 4, 8, 12. Ensures measurement reproducibility (±0.5 mm) across examiners/timepoints. Autoclaved between visits.	Device	Oxygen-Releasing Gel Therapy, Placebo Control, i-PRF Adjunctive Therapy

Primary outcome

Change in Clinical Attachment Level (CAL)
Time frame: Baseline, Weeks 4, 8, 12
Difference in CAL (mm) measured from custom acrylic stent reference point to base of periodontal pocket using UNC-15 periodontal probe at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) in sites with baseline CAL ≥5 mm. Primary endpoint: Week 12 CAL gain
Change in Probing Pocket Depth (PPD)
Time frame: Baseline, Weeks 4, 8, 12
Difference in PPD (mm) from gingival margin to pocket base via UNC-15 probe through stent notches. Primary endpoint: Week 12 PPD reduction.
Bleeding on Probing (BOP)
Time frame: Baseline, Weeks 4, 8, 12
Percentage of sites exhibiting bleeding within 30 seconds of gentle probing (presence/absence recorded).

2 secondary outcomes

Radiographic Bone Fill
Time frame: Baseline to Week 12
Gingival Index (GI)
Time frame: Baseline, Weeks 4, 8, 12

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 6 Nov 2026.
Results publicationVučković M, Nikolić N, Milašin J, Đorđević V, Milinković I, Asotić J, et al. The effect of injectable platelet-rich fibrin use in the initial treatment of chronic periodontitis. Srp Arh Celok Lek. 2020;148(5-6):280-5.
Results publication: PubMed 39364843Singh A, Vasudevan S, Palle AR, Atchuta A, Bhadauriya S. Comparative Evaluation of Scaling and Root Planing with and without Oxygen-releasing Gel in the Treatment of Chronic Periodontitis: A Split-mouth Study. J Contemp Dent Pract. 2024 May 1;25(5):445-452. doi: 10.5005/jp-journals-10024-3689.
Results publication: PubMed 8910821Genco RJ. Current view of risk factors for periodontal diseases. J Periodontol. 1996 Oct;67(10 Suppl):1041-9. doi: 10.1902/jop.1996.67.10.1041.
Results publication: PubMed 32383274Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
Individual participant dataSharing planned: Undecided

Related trials for Stage III Periodontitis

RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
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Recruiting
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Active, not recruitingObservational study
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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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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, Weeks 4, 8, 12). 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?

On the ClinicalTrials.gov record for NCT07859358, which also lists 4 linked publications.

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 6 Nov 2026.