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Recruiting NCT07722390

Minimally Invasive Non Surgical Treatment Using Injectable Platelet Concentrate in Treatment of Deep Pockets.

No phase Interventional Intrabony Periodontal Defects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Injectable PRF, MINST.
Who it may be relevant to
Registry conditions: Intrabony Periodontal Defects. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

The purpose of this study is to evaluate change in pocket depth following using minimally invasive non surgical combined with injectable platelet concentrate .

Interventions

  • Biological Injectable PRF
    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
  • Procedure MINST
    Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone using P3 Woodpecker piezoelectric scaler for the selected periodontal intrabony defect

Primary outcome measures

  • Change in pocket depth [Time frame: 6 months]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Smoker/vaper (currently or in past 5 years).
  • Contributory medical history (e.g. cardiovascular disease, diabetes, psychiatric conditions).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

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. PMID 31351492
  • Nibali L. Intrabony defects and non-surgical treatment. Prim Dent J. 2014 Aug;3(3):48-50. doi: 10.1308/205016814812736682. PMID 25198639
  • Mehta 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 38710583
  • Iorio-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 39402910
  • Alshoiby 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 37002441

Identifiers

NCT: NCT07722390 · PE R3-3-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗