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Effect of Nano-Hyaluronic Acid in Intrabony Defects Treated With Minimally Invasive Non-Surgical Technique

15. maj 2026 opdateret af: Mustafa Hussein Alshebli, Cairo University

Clinical Evaluation of Nano-Hyaluronic Acid as an Adjunctive to Minimally Invasive Non-Surgical Technique in the Treatment of Deep Intrabony Defects: Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate the effectiveness of using nano-hyaluronic acid (nano-HyA) gel alongside a minimally invasive non-surgical technique (MINST) to treat deep intrabony defects in patients with Stage II and III periodontitis. While MINST is a proven method for cleaning deep periodontal pockets without the need for traditional surgery , the addition of nano-HyA may further enhance soft tissue healing, reduce inflammation, and promote regeneration. Participants in the study will be randomly assigned to one of two groups. The test group will receive the MINST procedure combined with the application of nano-HyA gel into the periodontal pocket, while the control group will receive the MINST procedure alone. The primary goal of the study is to measure the decrease in probing pocket depth over a 6-month follow-up period to determine if the adjunctive use of nano-HyA provides superior clinical and radiographic outcomes compared to non-surgical treatment alone

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypten
        • Faculty of Dentistry, Cairo University

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:

  1. Males and females aged ≥ 18 years.
  2. Patients with a diagnosis of periodontitis (stage II or III).
  3. At least one tooth with ≥5 mm PPD and CAL and evidence of radiographic bone loss.
  4. Presenting with at least 1 intrabony defect, with a radiographic intra-bony component ≥3 mm.

Exclusion Criteria:

  1. Patients with systemic diseases.
  2. Pregnant or lactating females.
  3. Tobacco smokers (≥ 10 cigarettes per day).
  4. Multi-rooted teeth with class II and class III furcation defects.
  5. Third molars.
  6. Teeth with grade III mobility.
  7. Peri-apical pathology and acute abscess.
  8. Non-surgical or surgical periodontal treatment in the past 12 months.
  9. Prolonged treatment with antibiotics or anti-inflammatory agents within 6 months before periodontal therapy.

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: MINST alone
Participants receive the minimally invasive non-surgical technique (MINST) alone without adjunctive treatment
Procedure: Minimally invasive non-surgical technique (MINST)
Subgingival debridement using thin ultrasonic tips and additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization
Eksperimentel: MINST + nano-hyaluronic acid
Participants receive MINST combined with adjunctive nano-hyaluronic acid
Procedure: Minimally invasive non-surgical technique (MINST)
Subgingival debridement using thin ultrasonic tips and additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization
Biologisk: nano-hyaluronic acid
Pockets associated with intrabony defects are filled with nano-HyA paste immediately after subgingival debridement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pocket Depth (PD)
Tidsramme: "From enrollment to the end of treatment at 24 weeks"
Measured in millimeters (mm) from the gingival margin to the bottom of the gingival sulcus using a UNC-15 periodontal probe. Each tooth is probed at 6 sites with a light force not exceeding 25 grams.
"From enrollment to the end of treatment at 24 weeks"

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Full-Mouth Plaque Score (FMPS)
Tidsramme: From enrollment to the end of treatment at 24 weeks
Assessed as the percentage of sites with plaque.
From enrollment to the end of treatment at 24 weeks
Full-Mouth Bleeding Score (FMBS)
Tidsramme: From enrollment to the end of treatment at 24 weeks
Assessed as the percentage of sites with bleeding upon probing.
From enrollment to the end of treatment at 24 weeks
Clinical Attachment Level (CAL)
Tidsramme: From enrollment to the end of treatment at 24 weeks
Measured in millimeters (mm) from the cemento-enamel junction to the bottom of the pocket.
From enrollment to the end of treatment at 24 weeks
Gingival Recession (GR)
Tidsramme: From enrollment to the end of treatment at 24 weeks
Measured in millimeters (mm) from the cemento-enamel junction to the gingival margin.
From enrollment to the end of treatment at 24 weeks
Radiographic Defect Angle (RDA)
Tidsramme: From enrollment to the end of treatment at 24 weeks
Measured in degrees (°).
From enrollment to the end of treatment at 24 weeks
Patient Satisfaction
Tidsramme: From enrollment to the end of treatment at 24 weeks
Assessed via a Likert-scale questionnaire. The scale ranges from 1 to 5, where 1 indicates "Very Dissatisfied" and 5 indicates "Very Satisfied". Higher scores represent a better outcome.
From enrollment to the end of treatment at 24 weeks
Cost Effectiveness
Tidsramme: From enrollment to the end of treatment at 24 weeks
Evaluated through a health economic analysis, measured as currency per unit effect.
From enrollment to the end of treatment at 24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

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)

15. juli 2025

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

29. august 2026

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PER 3-3 -2

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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