Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
23. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Moustafa A Ahmed, B.D.S
- Telefonnummer: 00201098378998
- E-post: 23110295.pg@o6u.edu.eg
Studiesteder
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypt, 12511
- Rekruttering
- October 6 University (Faculty of Dentistry)
-
Underetterforsker:
- Reham L Aggour, MD
-
Ta kontakt med:
- Moustafa A Ahmed, B.D.S
- Telefonnummer: 00201098378998
- E-post: 23110295.pg@o6u.edu.eg
-
Underetterforsker:
- Shereen F Ahmed, MD
-
Underetterforsker:
- Wessam I Shehab, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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.
|
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.
|
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
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. mars 2026
Primær fullføring (Antatt)
11. mars 2027
Studiet fullført (Antatt)
11. mars 2027
Datoer for studieregistrering
Først innsendt
23. august 2026
Først innsendt som oppfylte QC-kriteriene
23. august 2026
Først lagt ut (Faktiske)
26. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 23110295
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
The data will be available upon a reasonable request from the corresponding author.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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