Intrabony DefectNCT07261878
Treatment of Intrabony Defect in Patient With Periodontitis Stage III by Using I-PRF and Xenograft
A study testing injectable platelet rich fibrin and xenograft and Xenograft alone in people with Intrabony Defect and Intrabony Defects in Chronic Periodontitis, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
Evaluate of the injectable platelet rich fibrin (I-PRF) with xenograft in Intrabony defects of Periodontitis patient stage III versus Xenograft alone. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Defect, Intrabony Defects in Chronic Periodontitis
- What is being tested?
- injectable platelet rich fibrin and xenograft and Xenograft alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 Feb 2025to 17 Dec 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient should have localized Periodontitis stage III grade B with pocket depth ≥ 6mm; indicated for periodontal surgery
- Patient's agreement to the surgical procedure and clinical trial.
- Age ranged between 30-55 years old.
- Intrabony defects with depth ≥3mm.
- Free from any systemic conditions and no previous drug affect bone metabolism
Who cannot join
- Smoking.
- Pregnant women.
- Patients in variation in anatomical landmarks.
- Patients with psychological problems.
- Patients with abnormal habits.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dental Medicine for Girls, Al- Azhar University
Cairo, Cairo Governorate
Ola Jamal
Cairo, Cairo Governorate
About this study
Official title: Injectable Platelet Rich Fibrin (I-PRF) With Xenograft in Intrabony Defects of Periodontitis Patient Stage III Versus Xenograft Alone
Evaluate of the injectable platelet rich fibrin (I-PRF) with xenograft in Intrabony defects of Periodontitis patient stage III versus Xenograft alone.
Read the detailed description
All surgical procedures will be conducted by a single operator. Following administration of local anesthesia, intrasulcular incisions will beperformed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded. In the group1: xenograft alone(Bovin xenograft)will be applied to the intrabony defect area. In the group 2: xenograft (Bovin xenograft) with injectable platelet Rich fibrin (I- PRF) will be applied to the intrabony defect area. Preperation of Injectable platelate Rich Fibrin (I-PRF) : will be prepared for each patient as follows: 5 ml of venous blood will be collected from the patient blood then placed in a plastic tube without any added material or coagulant and centrifuged at 700 rpm for 3 min. then mixed with Xenograft. Finally, the flap will be passively repositioned using interrupted 4-0 silk
- Being tested
- injectable platelet rich fibrin and xenograft, Xenograft alone
- Keywords
- I-PRF with xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable platelet rich fibrin and xenograftProcedure or surgery
Elevation of papilla preservation flap at the site of 3mm infrabony defect ,prepearing the I-PRF which is obtained from the patients own blood , centrifuged at 700 rpm in 3 min and mixed with xenograft than placed at the defect area after removal all the granulation tissue follow up after 3 and 6 months intervals
Xenograft aloneProcedure or surgery
Elevation of papilla preservation flap at the site of 3mm infrabony defect after removal all the granulation tissue, the xenograft alone inserted to the defect, suturing and follow up after 3 and 6 months intervals
| Study group | Role | What they receive |
|---|---|---|
| injectable platelet rich fibrin and xenograft | Other | Intrasulcular incisions will be performed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded .In the group 2: xenograft (Bovin xenograft) with injectable platelet Rich fibrin (I- PRF) will be applied to the intrabony defect area. Receives: Procedure: injectable platelet rich fibrin and xenograft; Procedure: Xenograft alone |
| xenograft alone | Active comparator | Intrasulcular incisions will be performed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded, inserting the xenograft to the defect Receives: Procedure: injectable platelet rich fibrin and xenograft; Procedure: Xenograft alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic parameters
- The bone fill after 6 months postoperatively using digital periapical radiography using parallel technique.
Measured: 6 months after treatment
Secondary outcomes (4)
Pocket depth (PD)
will be assessed by William graduated periodontal Probe in 4 surfaces of the tooth
Measured: presurgically, 3 and 6 months interval after treatment
Plaque index (PI)
According to Silness \& Loe, 4 readings will be recorded for each surface of the teeth (buccal, lingual, mesial and distal) and it is given a score from 0-3
Measured: pre-surgically 3 months and 6 months respectively
Gingival index (GI)
presence or absence of bleeding on upon gentle probing
Measured: pre-surgically 3 months and 6 months respectively
Clinical attachment level (CAL)
will be measured from the cement-enamel junction to the base of the pocket
Measured: pre-surgically 3 months and 6 months respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start17 Feb 2025
- Primary completion18 Feb 2025
- Study completion17 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony DefectStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Alsareh, Al-Azhar University
- Investigators
- Eatemad Ahmed Shoreibah A Shoreibah, Professor, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261878
- Sponsor's protocol ID
- P-ME-24-05
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Platelet Rich Fibrin (I-PRF) With Xenograft in Intrabony Defects of Periodontitis Patient Stage III Versus Xenograft Alone
- ClinicalTrials.gov ID
- NCT07261878
- Acronym / sponsor ID
- P-ME-24-05
- Keywords
- I-PRF with xenograft
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 17 Dec 2026 (estimated)
- First posted
- 3 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.
Evaluate of the injectable platelet rich fibrin (I-PRF) with xenograft in Intrabony defects of Periodontitis patient stage III versus Xenograft alone.
Detailed description
All surgical procedures will be conducted by a single operator. Following administration of local anesthesia, intrasulcular incisions will beperformed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded. In the group1: xenograft alone(Bovin xenograft)will be applied to the intrabony defect area. In the group 2: xenograft (Bovin xenograft) with injectable platelet Rich fibrin (I- PRF) will be applied to the intrabony defect area. Preperation of Injectable platelate Rich Fibrin (I-PRF) : will be prepared for each patient as follows: 5 ml of venous blood will be collected from the patient blood then placed in a plastic tube without any added material or coagulant and centrifuged at 700 rpm for 3 min. then mixed with Xenograft. Finally, the flap will be passively repositioned using interrupted 4-0 silk
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injectable platelet rich fibrin and xenograft | Other | Procedure: injectable platelet rich fibrin and xenograft, Procedure: Xenograft aloneIntrasulcular incisions will be performed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded .In the group 2: xenograft (Bovin xenograft) with injectable platelet Rich fibrin (I- PRF) will be applied to the intrabony defect area. |
| xenograft alone | Active comparator | Procedure: injectable platelet rich fibrin and xenograft, Procedure: Xenograft aloneIntrasulcular incisions will be performed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded, inserting the xenograft to the defect |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient should have localized Periodontitis stage III grade B with pocket depth ≥ 6mm; indicated for periodontal surgery
- Patient's agreement to the surgical procedure and clinical trial.
- Age ranged between 30-55 years old.
- Intrabony defects with depth ≥3mm.
- Free from any systemic conditions and no previous drug affect bone metabolism
Key exclusion criteria (5 listed)
- Smoking.
- Pregnant women.
- Patients in variation in anatomical landmarks.
- Patients with psychological problems.
- Patients with abnormal habits.
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 and xenograftElevation of papilla preservation flap at the site of 3mm infrabony defect ,prepearing the I-PRF which is obtained from the patients own blood , centrifuged at 700 rpm in 3 min and mixed with xenograft than placed at the defect area after removal all the granulation tissue follow up after 3 and 6 months intervals | Procedure or surgery | injectable platelet rich fibrin and xenograft, xenograft alone |
| Xenograft aloneElevation of papilla preservation flap at the site of 3mm infrabony defect after removal all the granulation tissue, the xenograft alone inserted to the defect, suturing and follow up after 3 and 6 months intervals | Procedure or surgery | injectable platelet rich fibrin and xenograft, xenograft alone |
Primary outcome
Radiographic parameters
Time frame: 6 months after treatment
• The bone fill after 6 months postoperatively using digital periapical radiography using parallel technique.
4 secondary outcomes
Pocket depth (PD)
Time frame: presurgically, 3 and 6 months interval after treatment
Plaque index (PI)
Time frame: pre-surgically 3 months and 6 months respectively
Gingival index (GI)
Time frame: pre-surgically 3 months and 6 months respectively
Clinical attachment level (CAL)
Time frame: pre-surgically 3 months and 6 months respectively
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 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
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Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
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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.
Eatemad Ahmed Shoreibah A Shoreibah, Professor study chair
Al-Azhar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injectable platelet rich fibrin and xenograft and Xenograft alone in people with Intrabony Defect and Intrabony Defects in Chronic Periodontitis, run by Al-Azhar University at 2 sites in Egypt.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. 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. 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?
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?
Radiographic parameters (time frame: 6 months after treatment). 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 3 Dec 2025.