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Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects (PN-HAVSEMPIND)

11. maj 2026 opdateret af: Shashi Dadlani

Polynucleotides and Hyaluronic Acid vs Enamel Matrix Derivative Proteins in the Treatment of Intrabony Defects: A Randomized Controlled Clinical Trial

The goal of this clinical trial is to compare two periodontal regenerative treatments in adults with Stage III or IV periodontitis and infrabony periodontal defects ≥3 mm.

The study aims to determine whether hyaluronic acid and polynucleotides (Regenfast®) combined with bovine bone graft material (Bio-Oss®) provides similar or improved periodontal regeneration compared with enamel matrix derivative proteins (Emdogain®) combined with Bio-Oss®.

Researchers will evaluate:

  • Periodontal healing and bone regeneration
  • Changes in probing depth, clinical attachment level, gingival recession, and tooth mobility
  • Radiographic bone fill
  • Survival of treated teeth after 1, 3, and 5 years

Participants will:

  • Receive initial periodontal treatment and oral hygiene instruction
  • Undergo clinical and radiographic evaluation
  • Receive minimally invasive periodontal regenerative surgery under local anesthesia
  • Be randomly assigned to receive either Regenfast® + Bio-Oss® or Emdogain® + Bio-Oss®
  • Attend follow-up visits with periodontal examinations and radiographs over 5 years

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This clinical study evaluates two regenerative approaches used during minimally invasive periodontal surgery for the treatment of infrabony periodontal defects deeper than 3 mm. The study compares a combination of hyaluronic acid and polynucleotides (Regenfast®) with enamel matrix derivative proteins (Emdogain®), both used together with a bovine bone graft material (Bio-Oss®).

This is a randomized, multicenter clinical study conducted in three specialized periodontal clinics by experienced periodontists. Adults with Stage III or IV periodontitis who continue to have deep periodontal defects after initial periodontal treatment may be eligible to participate.

Participants will first receive standard non-surgical periodontal treatment, including professional cleaning, root planing, oral hygiene instruction, and chlorhexidine mouth rinses. Eight weeks later, a clinical and radiographic reevaluation will be performed. Patients who meet the study criteria will undergo minimally invasive periodontal surgery using papilla preservation techniques.

During surgery, the periodontal defect will be cleaned and treated with one of the two regenerative materials selected randomly through a sealed-envelope allocation process. Patients will receive either Regenfast® with Bio-Oss® or Emdogain® with Bio-Oss®. All participants will receive local anesthesia, postoperative antibiotics, pain medication, and supportive periodontal care.

Researchers will monitor healing and treatment outcomes through clinical examinations and radiographic evaluations performed at 1 year, 3 years, and 5 years after surgery. Measurements will include periodontal pocket depth, gum recession, clinical attachment level, bleeding on probing, tooth mobility, and the amount of bone regeneration seen on radiographs. The study will also evaluate long-term tooth survival and analyze whether factors such as smoking habits or defect shape influence treatment outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

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:

  • Adults aged 18 years or older
  • Non-smokers or light smokers (fewer than 10 cigarettes per day)
  • No diabetes or well-controlled diabetes
  • At least one infrabony periodontal defect ≥ 3 mm in depth
  • Periodontal pocket depth ≥ 6 mm at baseline (after initial treatment)
  • Full-mouth plaque and bleeding scores ≤ 20%, ≤15% at re-evaluation
  • Ability and willingness to attend follow-up visits for 1, 3, and 5 years
  • Teeth included in the study must be healthy from an endodontic point of view or properly root-treated

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patients with weakened immune systems or significant systemic diseases
  • Heavy smokers (more than 10 cigarettes per day)
  • Full-mouth plaque or bleeding scores >20%, >15%
  • Current alcohol or drug abuse
  • Patients who have received periodontal treatment within the last 6 months
  • Patients unwilling or unable to attend follow-up visits required for the study

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss®
Name: Regenfast® + Bio-Oss® Intervention: Hyaluronic acid + polynucleotides (Regenfast®) combined with bovine bone graft (Bio-Oss®) Procedure: Applied during minimally invasive periodontal regenerative surgery
Procedure: Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss® graft

Combination Product: using PAPILLA Preservation Flap + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) REGENFAST+ Bio-Oss

• A PNHA gel will be placed on the root surfaces and infra-bony defects, followed by a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps using 5-0 suture
Aktiv komparator: Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss®
Name: Emdogain® + Bio-Oss® Intervention: Enamel matrix derivative proteins (Emdogain®) combined with bovine bone graft (Bio-Oss®) Procedure: Applied during minimally invasive periodontal regenerative surgery
Procedure: Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss® graft

Procedure: Papilla Preservation Flap

• A conservative access flap will be performed such as simplified papilla preservation flap (SPPF). Use of EDTA 24 %, EMDOGAIN AND BIO-OSS® suturing the flap by tension-free primary closure of the interdental papillae and of the mucoperiosteal using 5-0 suture

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Attachment Level
Tidsramme: Baseline, 12 months, 3 years, and 5 years after surgery
Measured as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket using a calibrated periodontal probe (PCP-UNC 15). Measurements will be recorded at six sites per tooth. Changes in CAL from baseline to 12 months, 3 years, and 5 years will be used to assess periodontal regeneration and treatment effectiveness.
Baseline, 12 months, 3 years, and 5 years after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Probing Pocket Depth
Tidsramme: Baseline, 12 months, 3 years, and 5 years post-surgery
Probing Pocket Depth (PPD) will be measured as the distance from the gingival margin to the base of the periodontal pocket using a calibrated periodontal probe (PCP-UNC 15). Measurements will be taken at six sites per tooth. Changes in PPD from baseline to follow-up visits will be used to assess periodontal healing and reduction of periodontal pocket depth.
Baseline, 12 months, 3 years, and 5 years post-surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Shashi Dadlani

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 (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

22. maj 2031

Studieafslutning (Anslået)

30. juli 2031

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26042703

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

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