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

31 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Reclutamento
        • Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Procedura: 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.
Procedura: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in peri-implant soft-tissue volume
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Early wound healing
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Plovdiv Medical University

Investigatori

  • Investigatore principale: Tasho Gavrailov, DMD, PhD, Medical University of Plovdiv

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2024

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

31 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 agosto 2026

Primo Inserito (Effettivo)

3 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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