Minimally Invasive Non Surgical Treatment Using Injectable Platelet Concentrate in Treatment of Deep Pockets.
28. juli 2026 opdateret af: Hania wael, Cairo University
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 .
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
48
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hania Haggag
- Telefonnummer: +01210239417
- E-mail: hania.haggag@dentistry.cu.edu.eg
Studiesteder
-
-
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Cairo, Egypten
- Rekruttering
- Cairo University
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Kontakt:
- Faculty of dentistry Cairo university
- Telefonnummer: +01002159535
- E-mail: dentmail@dentistry.cu.edu.eg
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention , MINST + IPRF
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.
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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
|
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Aktiv komparator: Control , MINST only
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.
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Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone using P3 Woodpecker piezoelectric scaler for the selected periodontal intrabony defect
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in pocket depth
Tidsramme: 6 months
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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
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pocket closure
Tidsramme: 6 months from baseline
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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
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6 months from baseline
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Clinical attachment gain
Tidsramme: 6 months from baseline
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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
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6 months from baseline
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Radiographic defect reduction:
Tidsramme: 6 months
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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
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6 months
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Patient reported outcomes
Tidsramme: 6 months
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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.
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Nibali L. Intrabony defects and non-surgical treatment. Prim Dent J. 2014 Aug;3(3):48-50. doi: 10.1308/205016814812736682.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. maj 2025
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. juni 2028
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PE R3-3-4
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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