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Non-surgical Treatment of Peri-implant Pockets With H42 (H42)

1. juli 2026 opdateret af: Bioteck S.p.A.

This prospective, observational study evaluates the efficacy and safety of H42 non-surgical treatment for peri-implant pockets. The trial involves 56 patients, with 28 subjects receiving the H42 treatment and 28 acting as a control group to monitor soft tissue healing and bone level changes.

Clinical outcomes focus on Pocket Probing Depth (PPD) and Silness and Löe Plaque Index (PI) measured at baseline, 1 month, and 3 months. Gingival inflammation, pain intensity on a 0-10 NRS scale, and absence of infection are monitored at baseline, 7, 14, and 21 days, and at 1 and 3 months. Additionally, a five-point tissue assessment evaluates color, suppuration, granulation tissue, bleeding, and incision margins. Radiographic analysis at baseline and 3 months uses standardized periapical x-rays to measure bone level, intra-bony defect height, width, and angulation. Safety is assessed through the continuous registration of adverse events.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

56

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Spanien
      • Seville, Spanien, 41009
        • Rekruttering
        • Faculty of Dentistry, University of Seville
        • Kontakt:
          • Guillermo Machuca-Portillo, MD
          • Telefonnummer: +34 954481128
          • E-mail: gmachuca@us.es

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

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Adult patients diagnosed with peri-implantitis and treated at the Department of Stomatology, Faculty of Dentistry, University of Seville, Spain. Participants are recruited from patients seeking care at the university dental clinic and are allocated to the study groups according to the study protocol and predefined inclusion and exclusion criteria. The study evaluates the adjunctive use of H42 hydrogel in the non-surgical treatment of peri-implantitis using a case-control design.

Beskrivelse

Inclusion Criteria:

  • Men or women with age ≥ 25 and ≤ 65 years.
  • Subjects affected by peri-implant pockets with probing depth (PD) in the range between 6 to 8 mm.
  • Each subject can have from 1 to 5 defects.
  • Subjects willing to provide signed informed consent to clinical investigation participation.

Exclusion Criteria:

  • Use of aspirin and antiplatelet agents a week before treatment.
  • Subjects smokers ≥ 10 cigarettes per day.
  • Subjects presenting current or previous bleeding disorders.
  • Subjects taking or having indications for anticoagulant therapy.
  • Concomitant treatments or procedures to improve gum health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, and surgery.
  • Subjects suffering from infectious diseases, including herpes simplex infection, active hepatitis, or human immunodeficiency virus.
  • Subjects with dental aesthetic surgery in the preceding 12 months before the clinical investigation enrolment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
H42 treated group
28 patients treated with ultrasonic treatment and manual curettes + H42®
Control group
28 patients only with ultrasonic treatment and manual curettes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pocket Probing Depth (PPD)
Tidsramme: At 1 month and 3 months in comparison with the baseline value
The distance measured from the base of the pocket to the most apical point on the gingival margin, and it will be measured with an electronic Florida probe at controlled pressure
At 1 month and 3 months in comparison with the baseline value
Plaque Index (PI)
Tidsramme: At 1 month and 3 months in comparison with the baseline
For each tooth, the four-point scale Silness and Löe Plaque Index is used (Score 0: Excellent; 3: poor)
At 1 month and 3 months in comparison with the baseline
Degree of inflammation
Tidsramme: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Not inflamed, mild inflamed, Moderately inflamed, Very inflamed
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
NRS scale
Tidsramme: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Numeric Rating Scale is a simple, reliable tool used to measure pain intensity on a scale from 0 to 10 (0: no pain; 10: maximum pain)
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Absence of infection
Tidsramme: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Clinical evaluation to assess the absence of infection, specifically defined as the absence of suppuration (pus formation), at the treated site as evaluated by the Investigator.
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tissue assessment
Tidsramme: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Color, suppuration, granulation tissue, bleeding on palpation and incision margins on a five-point scale: 1 is very poor, 2 is poor, 3 is good, 4 is very good, and 5 is excellent
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Radiographic image (x-ray)
Tidsramme: Baseline and 3 months follow-up
Periapical radiographs were taken using the parallel long cone technique using a customized film-holder device and a bite block. - Bone level (BL): distance (mm) between the implant shoulder and the base of the defect.
Baseline and 3 months follow-up

Samarbejdspartnere og efterforskere

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

Sponsor

Bioteck S.p.A.

Samarbejdspartnere

University of Seville

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

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)

3. december 2025

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 250423_H42_general

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Peri-implantitis

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Betingelser

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Placeringer

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