Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
23. august 2026 opdateret af: Moustafa Awadallah Elaref Ahmed, October 6 University
Evaluation of Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects: A Randomized Clinical Trial
This study aims to compare the clinical and radiographic effectiveness of injectable platelet-rich fibrin (i-PRF) combined with minimally invasive non-surgical therapy (MINST) versus MINST alone in the management of class II furcation defects.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
Periodontitis is a multifactorial inflammatory disease that occurs due to the challenge between the host response and specific periodontal pathogens, leading to a gradual destruction of the periodontal supporting tissues over time.
Different regenerative approaches have been proposed including guided tissue regeneration (GTR); bone grafts, bioactive agents such as enamel matrix derivative (EMD) and platelet concentrates.
Using the minimally invasive nonsurgical technique (MINST) implements magnification with microscope/loupes and delicate instruments, to perform the periodontal debridement with more effective root debridement and less soft tissue trauma. MINST significantly improve the visualization and root decontamination, and at the same time preserve the gingival margin and consequently improve the aesthetic results and tissue stability.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Moustafa A Ahmed, B.D.S
- Telefonnummer: 00201098378998
- E-mail: 23110295.pg@o6u.edu.eg
Studiesteder
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypten, 12511
- Rekruttering
- October 6 University (Faculty of Dentistry)
-
Underforsker:
- Reham L Aggour, MD
-
Kontakt:
- Moustafa A Ahmed, B.D.S
- Telefonnummer: 00201098378998
- E-mail: 23110295.pg@o6u.edu.eg
-
Underforsker:
- Shereen F Ahmed, MD
-
Underforsker:
- Wessam I Shehab, MD
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Patients of both genders >18 years old, medically free of systemic diseases affecting periodontal regeneration.
- Diagnosis of stage III, grade B periodontitis (according to the AAP/EFP classification 2018) with the presence of class II furcation defect in either the maxillary (buccal) or mandibular arch (buccal or lingual) as determined by clinical evaluation and confirmed by radiographic evaluation.
- Gingival margin and interdental bone positioned coronally to the furcation entrance.
- Commitment to maintenance visits and follow-up.
- Absence of primary endodontic lesions.
Exclusion Criteria:
- Patients suffering from any systemic diseases that may affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc;
- Patients that received periodontal surgical treatments in the past 12 months.
- Smoking (current or in past 5 years)
- Prolonged treatment with antibiotics or anti-inflammatory agents within 6 months prior to periodontal therapy.
- Pregnant and lactating females.
- Teeth with hopeless prognosis
- Third molars
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Positive control group
Patients will receive minimally invasive non-surgical technique (MINST) alone
|
Patients will receive minimally invasive non-surgical technique (MINST) alone
|
|
Eksperimentel: Test group
Patients will receive minimally invasive non-surgical technique (MINST) + injectable platelet-rich fibrin (i-PRF) injection
|
Patients will receive minimally invasive non-surgical technique (MINST) + injectable platelet-rich fibrin (i-PRF) injection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Radiographic Bone Fill at the Furcation Site
Tidsramme: 6 months after treatment
|
Radiographic bone fill at the furcation site will be assessed using cone-beam computed tomography (CBCT).
The analysis will include measurement of the filled bone volume (FBV) at the furcation area using segmentation.
|
6 months after treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Horizontal Clinical Attachment Level
Tidsramme: 6 months after treatment
|
Horizontal clinical attachment level will be assessed using periodontal probing at baseline and 6 months after treatment.
|
6 months after treatment
|
|
Change in Vertical Clinical Attachment Level
Tidsramme: 6 months after treatment
|
Vertical clinical attachment levels will be assessed using periodontal probing at baseline and 6 months after treatment.
|
6 months after treatment
|
|
Change in Probing Pocket Depth
Tidsramme: 6 months after treatment
|
Probing pocket depth (PPD) will be measured in millimeters from the gingival margin to the base of the periodontal sulcus at six sites per tooth using a UNC-15 periodontal probe.
Measurements will be recorded at baseline and 6 months after treatment.
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6 months after treatment
|
|
Change in Gingival Margin Location
Tidsramme: 6 months after treatment
|
The location of the gingival margin will be assessed by measuring the distance from the cemento-enamel junction (CEJ) to the gingival margin.
Measurements will be recorded at baseline and 6 months after treatment.
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6 months after treatment
|
|
Change in Plaque Index
Tidsramme: 6 months after treatment
|
Plaque index (PI) will be assessed to evaluate oral hygiene status by measuring dental plaque accumulation in areas adjacent to the gingival margin.
Plaque index will be recorded at baseline and 6 months after treatment.
|
6 months after treatment
|
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Change in Bleeding on Probing
Tidsramme: 6 months after treatment
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Bleeding on probing (BoP) will be assessed by gently inserting a periodontal probe into the gingival sulcus at the base of the interdental papilla and recording the intensity of bleeding after a short delay.
BoP will be assessed at baseline and 6 months after treatment.
|
6 months after treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
11. marts 2026
Primær færdiggørelse (Anslået)
11. marts 2027
Studieafslutning (Anslået)
11. marts 2027
Datoer for studieregistrering
Først indsendt
23. august 2026
Først indsendt, der opfyldte QC-kriterier
23. august 2026
Først opslået (Faktiske)
26. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23110295
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD-delingstidsramme
After the end of study for one year.
IPD-delingsadgangskriterier
The data will be available upon a reasonable request from the corresponding author.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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