Minimally Invasive Non Surgical Treatment Using Injectable Platelet Concentrate in Treatment of Deep Pockets.
The Effect of Adjunctive I-PRF on the Outcomes of Minimally-invasive Non-surgical Therapy of Periodontal Intrabony Defects.A Randomized Clinical Trial
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study is to evaluate change in pocket depth following using minimally invasive non surgical combined with injectable platelet concentrate .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2025
CompletedFirst Submitted
Initial submission to the registry
July 20, 2026
CompletedFirst Posted
Study publicly available on registry
July 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
July 29, 2026
July 1, 2026
2.6 years
July 20, 2026
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (4)
Pocket closure
6 months from baseline
Clinical attachment gain
6 months from baseline
Radiographic defect reduction:
6 months
Patient reported outcomes
6 months
Study Arms (2)
Intervention , MINST + IPRF
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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 minimally invasive non-surgical periodontal therapy (MINST) alone using P3 Woodpecker piezoelectric scaler for the selected periodontal intrabony defect
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Smoker/vaper (currently or in past 5 years).
- Contributory medical history (e.g. cardiovascular disease, diabetes, psychiatric conditions).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (5)
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.
PMID: 31351492BACKGROUNDNibali L. Intrabony defects and non-surgical treatment. Prim Dent J. 2014 Aug;3(3):48-50. doi: 10.1308/205016814812736682.
PMID: 25198639BACKGROUNDMehta 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.
PMID: 38710583BACKGROUNDIorio-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.
PMID: 39402910BACKGROUNDAlshoiby 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.
PMID: 37002441BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Biostatistician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master degree candidate
Study Record Dates
First Submitted
July 20, 2026
First Posted
July 23, 2026
Study Start
May 14, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
July 29, 2026
Record last verified: 2026-07