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Clinical Evaluation of Nano-Hydroxyapatite as an Adjunctive to Minimally Invasive Non-Surgical Technique in the Treatment of Deep Intra-bony Defects (MINST)

27. maj 2026 opdateret af: Salah Eddin Sheet, Cairo University

Clinical Evaluation of Nano-Hydroxyapatite as an Adjunctive to Minimally Invasive Non-Surgical Technique in the Treatment of Deep Intra-bony Defects: A Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate the effectiveness of using nano-hydroxyapatite (nHA) gel alongside a minimally invasive non-surgical technique (MINST) to treat deep intra-bony defects in patients with Stage III periodontitis. While MINST is an effective method for cleaning deep periodontal pockets without the need for traditional surgery, the addition of nHA may further enhance soft tissue healing, improve cellular interaction, and promote bone 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 nHA gel directly 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 nHA provides superior clinical outcomes compared to non-surgical treatment alone.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Egypten
      • Cairo, Egypten, 11511
        • Oral Medicine and Periodontology department, 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:

  • Systemically healthy adults aged 18-65 years.
  • No history of systemic diseases affecting periodontal status or bone metabolism (e.g., uncontrolled diabetes, osteoporosis).
  • Diagnosed with Stage III periodontitis according to the 2018 classification of periodontal diseases (with interdental CAL ≥5 mm, probing depth ≥6 mm).
  • Presence of at least one deep intra-bony defect (≥3 mm defect depth) in a single-rooted or multi-rooted tooth.
  • Willingness to participate and sign informed consent.

Exclusion Criteria:

  • Immunocompromised patients, uncontrolled diabetics (HbA1c ≥ 7.0%), or individuals with autoimmune disorders.
  • History of malignancy or chemotherapy/radiation in the past year.
  • Use of bisphosphonates, corticosteroids, immunosuppressive antibiotics or anti-inflammatory agents within 6 months before periodontal therapy.
  • Smokers (≥ 10 cigarettes per day).
  • Pregnant or breastfeeding women, confirmed via medical history and/or test.
  • Receipt of periodontal surgery or nonsurgical treatment within the last 6 months.
  • Teeth with peri-apical pathology, acute abscess, or grade III mobility.
  • Multi-rooted teeth with class II and class III furcation defects.
  • 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: 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 Gracey mini-curettes under magnification, deliberately avoiding subgingival rinsing to support blood clot stabilization
Eksperimentel: MINST + nano-hydroxyapatite
Participants receive MINST combined with the adjunctive application of nano-hydroxyapatite gel
Procedure: Minimally invasive non-surgical technique (MINST)
Subgingival debridement using thin ultrasonic tips and Gracey mini-curettes under magnification, deliberately avoiding subgingival rinsing to support blood clot stabilization
Biologisk: nano-hydroxyapatite
A single dose of nano-hydroxyapatite (nHA) gel applied subgingivally directly into the periodontal pocket associated with the intrabony defect immediately following debridement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Probing Pocket Depth (PPD)
Tidsramme: 6 months
Measured in millimeters (mm) using a manual periodontal probe (UNC-15)
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Attachment Level (CAL)
Tidsramme: 1, 3, and 6 months post-treatment.
Measured in millimeters (mm) using a manual periodontal probe (UNC-15).
1, 3, and 6 months post-treatment.
Gingival Recession (GR)
Tidsramme: 1, 3, and 6 months post-treatment.
Measured in millimeters (mm) using a manual periodontal probe (UNC-15).
1, 3, and 6 months post-treatment.
Radiographic Defect Angle (RDA)
Tidsramme: 1, 3, and 6 months post-treatment.
Measured in degrees (°) utilizing standardized periapical radiographs and measurement software.
1, 3, and 6 months post-treatment.
Patient Satisfaction
Tidsramme: 1, 3, and 6 months post-treatment.
Assessed via a structured questionnaire utilizing a Likert scale. The scale ranges from 1 to 5, where 1 indicates "Very Dissatisfied" and 5 indicates "Very Satisfied," meaning higher scores represent a better outcome.
1, 3, and 6 months post-treatment.
Full-Mouth Plaque Score (FMPS)
Tidsramme: 1, 3, and 6 months post-treatment.
Assessed as a percentage (%) using the Visible Plaque Index (O'Leary et al.). The index ranges from a minimum of 0% to a maximum of 100%. Higher percentages indicate a greater presence of plaque, representing a worse clinical outcome.
1, 3, and 6 months post-treatment.
Full-Mouth Bleeding Score (FMBS)
Tidsramme: 1, 3, and 6 months post-treatment.
Assessed as a percentage (%) using the Gingival Bleeding Index (Ainamo & Bay). The index ranges from a minimum of 0% to a maximum of 100%. Higher percentages indicate more widespread gingival bleeding, representing a worse clinical outcome.
1, 3, and 6 months post-treatment.
Cost Effectiveness based on Clinical Attachment Level (CAL)
Tidsramme: 6 months post-treatment.
Evaluated using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER), based on the cost in USD per millimeter (mm) of CAL improvement.
6 months post-treatment.
Cost Effectiveness based on Probing Pocket Depth (PPD)
Tidsramme: 6 months post-treatment.
Evaluated using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER), based on the cost in USD per millimeter (mm) of PPD improvement.
6 months post-treatment.

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)

1. juli 2025

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

28. august 2026

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PER 3 - 3 - 2

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