Bony DefectsPhase 1/2MINSTNCT07791238
Minimally Invasive Non-Surgical Periodontal Therapy Alone vs. Minimally Invasive Non-Surgical Periodontal Therapy With I-PRF With or Without Chlorhexidine on Stage III Periodontitis Patients
A Phase 1/2 study testing Minimally Invasive Nonsurgical Therapy, Injectable Platelet-Rich Fibrin and Chlorhexidine 2% in people with Bony Defects and Periodontal Disease, run by Cairo University.
Trial summary
This study aims to assess the effect of chlorhexidine augmented I-PRF together with MINST and I-PRF alone with MINST versus MINST alone in the treatment of stage III periodontitis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bony Defects, Periodontal Disease
- What is being tested?
- Minimally Invasive Nonsurgical Therapy, Injectable Platelet-Rich Fibrin and Chlorhexidine 2%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Oct 2027
- Phase
- Phase 1/2
- 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
- Patient-related criteria:
- Patient consulting in the outpatient clinic.
- Age ≥ 18 years old.
- Able to tolerate the study procedures.
- Patient ready to perform oral hygiene instructions.
- Compliance with the maintenance program.
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- Provide informed consent.
- Accepts the 6 months follow-up period.
- Teeth related criteria:
- Presence of at least one radiographic intrabony defect depth ≥3 mm.
- Patients with at least 10 teeth per arch.
- Presence at least of two teeth with PD ≥ 6 mm per quadrant.
- Isolated inter-proximal defect on a single-rooted tooth or mandibular molar, not extending to the furcation area.
- Untreated patients diagnosed with stage III with slow/moderate rate of progression grade (A/B) Periodontitis.
Who cannot join
- Patient-related criteria:
- Medically compromised patients.
- Pregnant or nursing women.
- Uncooperative patients.
- Smokers (> 10 cigarettes/day).
- Teeth related criteria:
Show all 13Show fewer
- Furcation involvement.
- Mobility ≥ degree 1
- Acute periodontal or endodontic abscesses
- Third molars
- Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.
- Antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy.
- Previous periodontal surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of I-PRF With or Without Chlorhexidine on Minimally Invasive Non-Surgical Periodontal Therapy in Stage III Periodontitis: A Randomized Clinical Trial
This study aims to assess the effect of chlorhexidine augmented I-PRF together with MINST and I-PRF alone with MINST versus MINST alone in the treatment of stage III periodontitis patients.
Read the detailed description
The microbial profile shift that occurs during the transition from periodontal health to gingivitis or periodontitis makes it clear that the initiation and progression of periodontal diseases depend totally upon the presence of a dental biofilm. This microbial shift provides the rationale for the main objective of periodontal therapy, which aims to convert the biofilm from being associated with disease to being associated with health. Accordingly, the most effective therapies depend on relatively nonspecific approaches that physically disrupt the biofilm and decrease the oral bacterial load (Craig, 2016).
Using modified PRF with anti-bacterial properties can be highly important as a topical surgical tool that promotes tissue healing and prevents local infection (Polak, Clemer-Shamai and Shapira, 2019; El-Sayed et al., 2026). Moreover, such application may reduce the need for systemic antibiotic regimens (Polak, Clemer-Shamai and Shapira, 2019).
More recently, a novel protocol termed minimally invasive nonsurgical therapy (MINST) has been proposed for the treatment of isolated deep pockets associated with intrabony defects. Treatment of deep periodontal pockets by means of MINST consists of careful scaling and root debridement using special ultrasonic devices with delicate tips and operating microscope under local anesthesia (Nibali et al., 2019).
Since the incorporation of antiseptics into I-PRF hasn't been tested clinically yet, this study intends to evaluate the clinical and radiographic effects of using Chorhexidine augmented injrctable-platelet-rich fibrin together minimally invasive non-surgical periodontal therapy in the treatment stage III periodontitis patients.
- Conditions
- Bony Defects, Periodontal Disease
- Being tested
- Minimally Invasive Nonsurgical Therapy, Injectable Platelet-Rich Fibrin, Chlorhexidine 2%
- Keywords
- Intrabony defects, periodontitis, MINST, i-PRF, CHX
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Nonsurgical TherapyProcedure or surgery
careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed.
Injectable Platelet-Rich FibrinBiological
careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient.
Chlorhexidine 2%Drug
careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. Before the collection and centrifugation of the blood from volunteers, 200 microliter of the drug solution is dispensed at the bottom of the eppendorf vial microtube and kept ready. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. Once I-PRF is obtained after centrifugation, 2 ml of it is added to the eppendorf vortexex
| Study group | Role | What they receive |
|---|---|---|
| MINST alone | Active comparator | careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed Receives: Procedure: Minimally Invasive Nonsurgical Therapy |
| MINST + I-PRF alone | Experimental | careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. Receives: Procedure: Minimally Invasive Nonsurgical Therapy; Biological: Injectable Platelet-Rich Fibrin |
| MINST + I-PRF + CHX | Experimental | careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. Before the collection and centrifugation of the blood from volunteers, 200 microliter of the drug solution is dispensed at the bottom of the eppendorf vial microtube and kept ready. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. Once I-PRF is obtained after centrifugation, 2 ml of it is added to the eppendorf vortexex Receives: Procedure: Minimally Invasive Nonsurgical Therapy; Biological: Injectable Platelet-Rich Fibrin; Drug: Chlorhexidine 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth reduction (PD)
Will be measured from the gingival margin to the bottom of the gingival sulcus. Unit of Measurement Millimeter
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (8)
Clinical Attachment Level (CAL)
Will be measured from the CEJ to the bottom of the gingival sulcus. Unit of Measurement Millimeter
Measured: From enrollment to the end of treatment at 6 months
Gingival recessions (GR)
Will be measured from the CEJ to the gingival margin. Unit of Measurement Millimeter
Measured: From enrollment to the end of treatment at 6 months
Biochemical marker levels in GCF samples (TNF-α, IL-1β and IL-10 levels)
- GCF sampling will be collected from the deepest pocket in the interproximal sites of the selected teeth of all patients at baseline; 1 day after recording the clinical periodontal measurements, 3 and 6 months.
- The site selected for sample collection will be isolated with cotton rolls and protected against saliva contamination.
- The supragingival plaque in the site will be removed using cotton pellets.
- Periopaper will be pushed into the gingival sulcus until mild resistance felt.
- After 30 seconds, it will be removed, and its volume will be measured by the Periotron device. Before each sample collection, the standardization will be maintained by the calibration of the Periotron device.
- The measured values will be converted to microliters.
- Three GCF samples from each patient will be placed into single Eppendorf tubes and stored at -80 degrees until the biochemical analyses.
- Enzyme-linked immunosorbent assay (ELISA) method will be used to determine the GCF levels
Measured: From enrollment to the end of treatment at 6 months
Patient reported outcomes
Oral health-related quality of life (OHRQoL) will be evaluated using the validated Oral Health Impact Profile (OHIP-14) questionnaire, a widely used instrument designed to assess the functional, psychological, and social effects of oral health conditions on daily life. The OHIP-14 includes 14 items distributed across seven conceptual domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.
Participants will complete the OHIP-14 questionnaire at baseline and again at the 6-month post-treatment follow-up to determine changes in their perceived oral health status and overall quality of life. The inclusion of this patient-reported outcome measure allows for a broader assessment of treatment outcomes, capturing patient perceptions and experiences in addition to clinical findings.
Unit of Measurement: OHIP-1TO, OHIP-14
Measured: at end of treatment at 6 months
Perceived post-operative pain/discomfort
- Visual Analog Scale (VAS): 0 (no pain) to 10 (worst pain).
- Binary (Yes/No): Presence or absence of pain. unit of measurement: VAS Scale
Measured: at the end of treatment at 6 months
Radiographic Linear defect depth (RLDD)
The radiographic linear defect depth (RLDD) will be calculated as the linear distance between the defect base (DB) and the point where a line projected from the alveolar crest (AC) intersects the long axis of the tooth at baseline and again at the 6-month follow-up. In addition, the baseline defect angle will be determined as the angle formed between the line joining the CEJ and DB and the lateral wall of the defect. Unit of Measurement : Millimeter
Measured: From enrollment to the end of treatment at 6 months
Plaque index (PI)
After drying the teeth in each quadrant with a blast of air, and presence of visible dental plaque and supragingival calculus will be recorded.
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) will be given a score from 0-3.
The scores from the four areas of the tooth will be added and divided by four to give the plaque index for the tooth with the following scores and criteria.
Unit of measurement: Percentage of tooth sites revealing the presence of plaque
Measured: From enrollment to the end of treatment at 6 months
Bleeding on probing
By gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded . Unit of measurement: Percentage of sites with bleeding on probing
Measured: From enrollment to the end of treatment at 6 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 start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bony DefectsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ossama Ezzat Moursy, Cairo University
- Investigators
- Karim Fawzy El-sayed, Professor, Study chair, Cairo UniversityWeam Elbattawy, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791238
- Sponsor's protocol ID
- PER333
- Acronym
- MINST
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.
PubMed 31351492
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
- Impact of I-PRF With or Without Chlorhexidine on Minimally Invasive Non-Surgical Periodontal Therapy in Stage III Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07791238
- Acronym / sponsor ID
- MINST / PER333
- Conditions
- Bony Defects, Periodontal Disease
- Keywords
- Intrabony defects, periodontitis, MINST, i-PRF, CHX
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- 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 study aims to assess the effect of chlorhexidine augmented I-PRF together with MINST and I-PRF alone with MINST versus MINST alone in the treatment of stage III periodontitis patients.
Detailed description
The microbial profile shift that occurs during the transition from periodontal health to gingivitis or periodontitis makes it clear that the initiation and progression of periodontal diseases depend totally upon the presence of a dental biofilm. This microbial shift provides the rationale for the main objective of periodontal therapy, which aims to convert the biofilm from being associated with disease to being associated with health. Accordingly, the most effective therapies depend on relatively nonspecific approaches that physically disrupt the biofilm and decrease the oral bacterial load (Craig, 2016).
Using modified PRF with anti-bacterial properties can be highly important as a topical surgical tool that promotes tissue healing and prevents local infection (Polak, Clemer-Shamai and Shapira, 2019; El-Sayed et al., 2026). Moreover, such application may reduce the need for systemic antibiotic regimens (Polak, Clemer-Shamai and Shapira, 2019).
More recently, a novel protocol termed minimally invasive nonsurgical therapy (MINST) has been proposed for the treatment of isolated deep pockets associated with intrabony defects. Treatment of deep periodontal pockets by means of MINST consists of careful scaling and root debridement using special ultrasonic devices with delicate tips and operating microscope under local anesthesia (Nibali et al., 2019).
Since the incorporation of antiseptics into I-PRF hasn't been tested clinically yet, this study intends to evaluate the clinical and radiographic effects of using Chorhexidine augmented injrctable-platelet-rich fibrin together minimally invasive non-surgical periodontal therapy in the treatment stage III periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MINST alone | Active comparator | Procedure: Minimally Invasive Nonsurgical Therapycareful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed |
| MINST + I-PRF alone | Experimental | Procedure: Minimally Invasive Nonsurgical Therapy, Biological: Injectable Platelet-Rich Fibrincareful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. |
| MINST + I-PRF + CHX | Experimental | Procedure: Minimally Invasive Nonsurgical Therapy, Biological: Injectable Platelet-Rich Fibrin, Drug: Chlorhexidine 2%careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. Before the collection and centrifugation of the blood from volunteers, 200 microliter of the drug solution is dispensed at the bottom of the eppendorf vial microtube and kept ready. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. Once I-PRF is obtained after centrifugation, 2 ml of it is added to the eppendorf vortexex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient-related criteria:
- Presence of at least one radiographic intrabony defect depth ≥3 mm.
- Patients with at least 10 teeth per arch.
- Presence at least of two teeth with PD ≥ 6 mm per quadrant.
- Isolated inter-proximal defect on a single-rooted tooth or mandibular molar, not extending to the furcation area.
Key exclusion criteria (13 listed)
- Patient-related criteria:
- Furcation involvement.
- Mobility ≥ degree 1
- Acute periodontal or endodontic abscesses
- Third molars
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 |
|---|---|---|
| Minimally Invasive Nonsurgical Therapycareful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. | Procedure or surgery | MINST + I-PRF + CHX, MINST + I-PRF alone, MINST alone |
| Injectable Platelet-Rich Fibrincareful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. | Biological | MINST + I-PRF + CHX, MINST + I-PRF alone |
| Chlorhexidine 2%careful subgingival debridement using specific thin-tipped ultrasonic scalers in order to minimize the trauma for the soft tissues. All treatments will be performed using X 3.5 magnification Loupes. At the end of the subgingival treatment, full-mouth supragingival cleaning by means of a rubber cup and a polishing paste will be performed. Before the collection and centrifugation of the blood from volunteers, 200 microliter of the drug solution is dispensed at the bottom of the eppendorf vial microtube and kept ready. A venous blood sample was collected in a 10-mL plastic tube without anticoagulant from each patient and centrifuged at room temperature for 3 min at 700 rpm (60 g) in a PRF Duo centrifuge. After centrifugation, the upper liquid layer was collected as i-PRF and placed into a 2.5-cc dental injector. Approximately 2 mL of I-PRF was obtained from the patient. Once I-PRF is obtained after centrifugation, 2 ml of it is added to the eppendorf vortexex | Drug | MINST + I-PRF + CHX |
Primary outcome
Probing depth reduction (PD)
Time frame: From enrollment to the end of treatment at 6 months
Will be measured from the gingival margin to the bottom of the gingival sulcus. Unit of Measurement Millimeter
8 secondary outcomes
Clinical Attachment Level (CAL)
Time frame: From enrollment to the end of treatment at 6 months
Gingival recessions (GR)
Time frame: From enrollment to the end of treatment at 6 months
Biochemical marker levels in GCF samples (TNF-α, IL-1β and IL-10 levels)
Time frame: From enrollment to the end of treatment at 6 months
Patient reported outcomes
Time frame: at end of treatment at 6 months
Perceived post-operative pain/discomfort
Time frame: at the end of treatment at 6 months
Radiographic Linear defect depth (RLDD)
Time frame: From enrollment to the end of treatment at 6 months
Plaque index (PI)
Time frame: From enrollment to the end of treatment at 6 months
Bleeding on probing
Time frame: From enrollment to the end of treatment at 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 27 Aug 2026.
- Background: PubMed 31351492Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.
- 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.
Karim Fawzy El-sayed, Professor study chair
Cairo University
Weam Elbattawy, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Minimally Invasive Nonsurgical Therapy, Injectable Platelet-Rich Fibrin and Chlorhexidine 2% in people with Bony Defects and Periodontal Disease, run by Cairo University.
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 14 inclusion and 13 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: opening soon, 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.
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.
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?
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 Salma ossama Zaaya, Master Degree ((+20)1111101489, salma.ezzat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth reduction (PD) (time frame: From enrollment to the end of treatment at 6 months). 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 NCT07791238, which also lists 1 linked publication.
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.