Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes (IMPLA-CHA)

31. august 2026 oppdatert av: Plovdiv Medical University

Evaluation of the Success of Immediate Implants in the Molar Region Using Individually Fabricated Healing Abutments (Sulcus Formers) in Different Classes of Post-Extraction Sockets: A Prospective Cohort Study

Immediate implant placement into a fresh extraction socket shortens overall treatment time and reduces the number of surgical procedures, but the fit between the implant and the socket walls, and the resulting soft-tissue contour, differ substantially between socket types. This study evaluates immediate implant placement in the molar and posterior region combined with an individually fabricated (customized) healing abutment, or sulcus former, that seals the socket and shapes the emergence profile from the day of surgery.

Consecutive patients with a non-restorable posterior tooth are treated with flapless atraumatic extraction, immediate implant placement, grafting of the residual gap, and a chairside customized healing abutment fabricated on a titanium temporary abutment. Participants are grouped by the class of the post-extraction socket (A, B or C) according to the interradicular septal bone available for primary stability.

Outcomes are preservation of peri-implant soft-tissue volume assessed with an intraoral scanner, preservation of alveolar bone volume assessed on cone-beam computed tomography, implant stability measured by resonance frequency analysis (ISQ) at placement and before loading, and time to definitive loading. Early wound healing on the Landry index, the degree of bone corticalization before loading, implant survival, healing-abutment complications and analgesic requirement are also recorded.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

60

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Rekruttering
        • Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv
        • Ta kontakt med:

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

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Consecutive adult patients attending the Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv, with a non-restorable posterior (premolar or molar) tooth indicated for extraction and suitable for immediate implant placement.

Beskrivelse

Inclusion Criteria:

  • Age 18 years or over
  • ASA physical status I or II
  • A non-restorable posterior tooth (premolar or molar) indicated for extraction: clinically unrestorable crown, advanced chronic periodontitis, failed or untreatable endodontic therapy, or vertical root fracture
  • Residual bone permitting implant placement with adequate primary stability
  • Able and willing to give written informed consent and to attend the follow-up schedule

Exclusion Criteria:

  • ASA physical status III or higher
  • Pregnancy or lactation
  • Uncontrolled diabetes mellitus
  • Smoking more than 10 cigarettes per day
  • Drug or alcohol abuse
  • Current or previous bisphosphonate or other antiresorptive therapy
  • Head and neck radiotherapy
  • Immunosuppression
  • Anticoagulant or antiplatelet therapy where the required pre-operative preparation is declined
  • Psychiatric conditions preventing compliance with the study procedures
  • Known titanium allergy
  • Severe bruxism
  • Acute infection at the surgical site
  • Advanced alveolar resorption precluding immediate implant placement

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Socket class A
Posterior extraction socket in which the interradicular septal bone is sufficient to house the implant, giving circumferential bone contact along its coronal part. Because a molar socket is frequently 10 mm or more across, a residual void commonly remains around the implant within the socket. Participants receive immediate implant placement with a chairside customized healing abutment.
Fremgangsmåte: Immediate implant placement with customized healing abutment
Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone. Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact. No barrier membrane is used. Definitive loading is planned at three months.
Socket class B
Posterior extraction socket in which the septal bone is sufficient to stabilise the implant but not to house it, so that part of the implant surface faces the socket rather than bone. Participants receive immediate implant placement with a chairside customized healing abutment.
Fremgangsmåte: Immediate implant placement with customized healing abutment
Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone. Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact. No barrier membrane is used. Definitive loading is planned at three months.
Socket class C
Posterior extraction socket with little or no septal bone, so that primary stability must be obtained from the peripheral socket walls and/or the bone apical to the socket. Participants receive immediate implant placement with a chairside customized healing abutment.
Fremgangsmåte: Immediate implant placement with customized healing abutment
Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone. Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact. No barrier membrane is used. Definitive loading is planned at three months.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in peri-implant soft-tissue volume
Tidsramme: Baseline, 3 months after placement (before loading), and 2 weeks after loading
Volumetric change of the peri-implant soft tissue relative to the pre-extraction baseline, measured in cubic millimetres by superimposition of intraoral scans.
Baseline, 3 months after placement (before loading), and 2 weeks after loading
Time to definitive loading
Tidsramme: Up to 6 months after implant placement
Interval in months from implant placement to definitive prosthetic loading, determined by the pre-loading radiographic assessment and the implant stability quotient.
Up to 6 months after implant placement
Implant stability quotient (ISQ)
Tidsramme: At implant placement and at 3 months after placement (before loading)
Implant stability measured by resonance frequency analysis on the ISQ scale from 1 to 100, where higher values indicate greater stability. Stability before loading is the criterion that determines whether the implant is loaded at three months.
At implant placement and at 3 months after placement (before loading)
Change in alveolar bone volume
Tidsramme: Baseline and 3 months after placement (before loading)
Volumetric change of the peri-implant alveolar bone relative to the pre-extraction baseline, measured in cubic millimetres on cone-beam computed tomography.
Baseline and 3 months after placement (before loading)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Early wound healing
Tidsramme: Days 7 and 14 after surgery
Early wound healing graded on the Landry Wound Healing Index from 1 to 5, where higher values indicate better healing.
Days 7 and 14 after surgery
Analgesic requirement
Tidsramme: First 5 days after surgery
Number of participants taking the prescribed analgesic (ibuprofen L-arginine 600 mg twice daily as needed) after surgery.
First 5 days after surgery
Customized healing abutment complications
Tidsramme: From surgery to definitive loading, up to 4 months
Number of participants with abutment screw loosening, fracture of the composite healing abutment, or peri-implant infection, each recorded as present or absent.
From surgery to definitive loading, up to 4 months
Implant survival
Tidsramme: Up to 24 months after implant placement
Proportion of implants in situ and functional at the latest follow-up visit.
Up to 24 months after implant placement
Peri-implant bone corticalization
Tidsramme: 3 months after placement (before loading)
Degree of corticalization of the peri-implant bone, assessed on cone-beam computed tomography using a radiological corticalization index.
3 months after placement (before loading)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Plovdiv Medical University

Etterforskere

  • Hovedetterforsker: Tasho Gavrailov, DMD, PhD, Medical University of Plovdiv

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)

1. april 2024

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

31. august 2026

Først innsendt som oppfylte QC-kriteriene

31. august 2026

Først lagt ut (Faktiske)

3. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NO-18/2025
  • R-KNE-55/10.11.2025 (Annen identifikator: Committee on Scientific Ethics, Medical University of Plovdiv)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be made publicly available. De-identified data supporting the published analyses are available from the corresponding author on reasonable request.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere