Intrabony Periodontal DefectsNCT07722390
Minimally Invasive Non Surgical Treatment Using Injectable Platelet Concentrate in Treatment of Deep Pockets.
A study testing Injectable PRF and MINST in people with Intrabony Periodontal Defects, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate change in pocket depth following using minimally invasive non surgical combined with injectable platelet concentrate . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defects
- What is being tested?
- Injectable PRF and MINST
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2025to Jun 2028
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with periodontitis stage III-IV.
- Presence of at least one intrabony defect with radiographic component ≥ 3mm deep and PPD≥ 6mm (not affecting a tooth with 'hopeless' prognosis).
- Patients willing to sign informed consent and to be in the study until the 6-months follow-up.
- Full-mouth plaque score <30% following step 1 periodontal therapy
Who cannot join
- Smoker/vaper (currently or in past 5 years).
- Contributory medical history (e.g. cardiovascular disease, diabetes, psychiatric conditions).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Faculty of dentistry Cairo university, +01002159535, dentmail@dentistry.cu.edu.eg
About this study
Official title: The Effect of Adjunctive I-PRF on the Outcomes of Minimally-invasive Non-surgical Therapy of Periodontal Intrabony Defects.A Randomized Clinical Trial
The purpose of this study is to evaluate change in pocket depth following using minimally invasive non surgical combined with injectable platelet concentrate .
- Conditions
- Intrabony Periodontal Defects
- Being tested
- Injectable PRF, MINST
- Keywords
- intrabony defect - MINST - IPR-F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable PRFBiological
I-PRF will be prepared from 10 mL of autologous venous blood and injected into the cleaned defect, followed by placement of a custom-made transparent vacuum-formed stent for 15 minutes to prolong local contact
MINSTProcedure or surgery
Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone using P3 Woodpecker piezoelectric scaler for the selected periodontal intrabony defect
| Study group | Role | What they receive |
|---|---|---|
| Intervention , MINST + IPRF | Experimental | Participants will receive minimally invasive non-surgical periodontal therapy (MINST) with adjunctive local application of injectable platelet-rich fibrin (I-PRF) into the selected periodontal intrabony defect. I-PRF will be prepared from 10 mL of autologous venous blood and injected into the cleaned defect, followed by placement of a custom-made transparent vacuum-formed stent for 15 minutes to prolong local contact. Participants will receive standard oral hygiene instructions and periodontal follow-up. Receives: Biological: Injectable PRF |
| Control , MINST only | Active comparator | Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone for the selected periodontal intrabony defect, without adjunctive I-PRF or other biomaterials. Participants will receive standard oral hygiene instructions and periodontal follow-up. Receives: Procedure: MINST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pocket depth
Baseline measurements will be taken at the first visit. Probing depth will be measured at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) using a UNC-15 periodontal probe
Measured: 6 months
Secondary outcomes (4)
Pocket closure
Pocket depth of less than or equal 4 millimeters with no bleeding on probing at 6-month follow-up. PD will be measured from the gingival margin to the base of the pocket at six sites per tooth using a UNC-15 periodontal probe. PD reduction will be calculated by subtracting the 6-month PD from baseline PD
Measured: 6 months from baseline
Clinical attachment gain
CAL will be measured from the cementoenamel junction (CEJ) to the base of the pocket at the same six sites using a UNC-15 periodontal probe. CAL gain will be calculated by subtracting follow-up CAL (6 months) from baseline CAL
Measured: 6 months from baseline
Radiographic defect reduction:
Periapical radiographs of selected study sites will be taken at baseline and at 6 months using the parallel technique with Rinn holders. Each participating practice used the same setting and exposure time for radiographs taken at both visits to standardize positioning and minimize distortion of sequential radiographs
Measured: 6 months
Patient reported outcomes
To evaluate patient perceptions about the performed procedure and post-therapy period. The extent of discomfort and/or pain experienced will be evaluated using a horizontal visual analog scale (VAS) measured from scale from 1 to 10 where 1 is the lowest \& 10 is the highest.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start14 May 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intrabony Periodontal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hania wael, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722390
- Sponsor's protocol ID
- PE R3-3-4
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 31351492Nibali L. Intrabony defects and non-surgical treatment. Prim Dent J. 2014 Aug;3(3):48-50. doi: 10.1308/205016814812736682.
PubMed 25198639Mehta J, Montevecchi M, Garcia-Sanchez R, Onabolu O, Linares A, Eriksson F, Ghezzi C, Donghi C, Lu EM, Nibali L. Minimally invasive non-surgical periodontal therapy of intrabony defects: A prospective multi-centre cohort study. J Clin Periodontol. 2024 Jul;51(7):905-914. doi: 10.1111/jcpe.13984. Epub 2024 May 6.
PubMed 38710583Iorio-Siciliano V, Blasi A, Mauriello L, Salvi GE, Ramaglia L, Sculean A. Non-Surgical Treatment of Moderate Periodontal Intrabony Defects With Adjunctive Cross-Linked Hyaluronic Acid: A Single-Blinded Randomized Controlled Clinical Trial. J Clin Periodontol. 2025 Feb;52(2):310-322. doi: 10.1111/jcpe.14078. Epub 2024 Oct 14.
PubMed 39402910Alshoiby MM, Fawzy El-Sayed KM, Elbattawy W, Hosny MM. Injectable platelet-rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jul;27(7):3457-3467. doi: 10.1007/s00784-023-04954-y. Epub 2023 Mar 31.
PubMed 37002441
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adjunctive I-PRF on the Outcomes of Minimally-invasive Non-surgical Therapy of Periodontal Intrabony Defects.A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07722390
- Acronym / sponsor ID
- PE R3-3-4
- Conditions
- Intrabony Periodontal Defects
- Keywords
- intrabony defect - MINST - IPR-F
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 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.
The purpose of this study is to evaluate change in pocket depth following using minimally invasive non surgical combined with injectable platelet concentrate .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention , MINST + IPRF | Experimental | Biological: Injectable PRFParticipants will receive minimally invasive non-surgical periodontal therapy (MINST) with adjunctive local application of injectable platelet-rich fibrin (I-PRF) into the selected periodontal intrabony defect. I-PRF will be prepared from 10 mL of autologous venous blood and injected into the cleaned defect, followed by placement of a custom-made transparent vacuum-formed stent for 15 minutes to prolong local contact. Participants will receive standard oral hygiene instructions and periodontal follow-up. |
| Control , MINST only | Active comparator | Procedure: MINSTParticipants will receive minimally invasive non-surgical periodontal therapy (MINST) alone for the selected periodontal intrabony defect, without adjunctive I-PRF or other biomaterials. Participants will receive standard oral hygiene instructions and periodontal follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with periodontitis stage III-IV.
- Presence of at least one intrabony defect with radiographic component ≥ 3mm deep and PPD≥ 6mm (not affecting a tooth with 'hopeless' prognosis).
- Patients willing to sign informed consent and to be in the study until the 6-months follow-up.
- Full-mouth plaque score <30% following step 1 periodontal therapy
Key exclusion criteria (2 listed)
- Smoker/vaper (currently or in past 5 years).
- Contributory medical history (e.g. cardiovascular disease, diabetes, psychiatric conditions).
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 PRFI-PRF will be prepared from 10 mL of autologous venous blood and injected into the cleaned defect, followed by placement of a custom-made transparent vacuum-formed stent for 15 minutes to prolong local contact | Biological | Intervention , MINST + IPRF |
| MINSTParticipants will receive minimally invasive non-surgical periodontal therapy (MINST) alone using P3 Woodpecker piezoelectric scaler for the selected periodontal intrabony defect | Procedure or surgery | Control , MINST only |
Primary outcome
Change in pocket depth
Time frame: 6 months
Baseline measurements will be taken at the first visit. Probing depth will be measured at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) using a UNC-15 periodontal probe
4 secondary outcomes
Pocket closure
Time frame: 6 months from baseline
Clinical attachment gain
Time frame: 6 months from baseline
Radiographic defect reduction:
Time frame: 6 months
Patient reported outcomes
Time frame: 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 29 Jul 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.
- Background: PubMed 25198639Nibali L. Intrabony defects and non-surgical treatment. Prim Dent J. 2014 Aug;3(3):48-50. doi: 10.1308/205016814812736682.
- Background: PubMed 38710583Mehta J, Montevecchi M, Garcia-Sanchez R, Onabolu O, Linares A, Eriksson F, Ghezzi C, Donghi C, Lu EM, Nibali L. Minimally invasive non-surgical periodontal therapy of intrabony defects: A prospective multi-centre cohort study. J Clin Periodontol. 2024 Jul;51(7):905-914. doi: 10.1111/jcpe.13984. Epub 2024 May 6.
- Background: PubMed 39402910Iorio-Siciliano V, Blasi A, Mauriello L, Salvi GE, Ramaglia L, Sculean A. Non-Surgical Treatment of Moderate Periodontal Intrabony Defects With Adjunctive Cross-Linked Hyaluronic Acid: A Single-Blinded Randomized Controlled Clinical Trial. J Clin Periodontol. 2025 Feb;52(2):310-322. doi: 10.1111/jcpe.14078. Epub 2024 Oct 14.
- Background: PubMed 37002441Alshoiby MM, Fawzy El-Sayed KM, Elbattawy W, Hosny MM. Injectable platelet-rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jul;27(7):3457-3467. doi: 10.1007/s00784-023-04954-y. Epub 2023 Mar 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable PRF and MINST in people with Intrabony Periodontal Defects, run by Cairo University at 1 site 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 4 inclusion and 2 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 29 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 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?
Contact Hania Haggag (+01210239417, hania.haggag@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pocket depth (time frame: 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 NCT07722390, which also lists 5 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 29 Jul 2026.