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Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism

21 gennaio 2022 aggiornato da: Addbio AB

A Randomized, Multicentre, Double Blind, Parallel Study to Evaluate the Performance and Safety of the Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism

A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study will consist of two parts. Part I, is the main study ending when all subjects have reached visit 5. The study will be evaluated and Clinical Study Report (CSR) will be written for this part.

Part II, of the study is a post-follow up study starting when the first subject has completed visit 5. There will be a separate CSR written for Study Part II.

The study Part I will begin with a baseline visit, visit 1, Informed consent procedure will take place. Provided the subject will give informed consent for both Study Part I and Study Part II the screening procedure starts. Subjects will undergo all screening and baseline assessment procedures including assessments of dental status to determine number of implants needed. Subjects who meet all the inclusion criteria and none of the exclusion criteria will be given a date for implant surgery within three weeks. The required number of implants will be ordered from the Study Distributor.

At the implantation day, visit 2, eligibility will be re-checked before the surgery procedures starts. The subjects who still are eligible will enter the treatment and the implantation surgery is conducted. The first follow-up visit after implantation will take place week 2 post-surgery and the last follow-up visit in Study Part I will be at week 12. Any post-surgical complications and adverse events will be collected and recorded in the eCRF. On demand, depending on the outcome of the surgery, additional visits might occur.

Study Part II, the Post Follow-up Study, consist of two visits, one at month 12 and another visit at month 24 post-surgery. Post-surgical complications and adverse events from Study Part I will be followed-up if not resolved previously. Safety, survival rate and marginal bone loss will be assessed and outcome recorded in the eCRF. Additional visits might occur depending on the status of the subjects.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

62

Fase

  • Non applicabile

Contatti e Sedi

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

Luoghi di studio

  • Svezia
      • Dingle, Svezia, 45561
        • Dingletandläkarna
      • Falun, Svezia, 79171
        • Praktikertjänst AB Holmgatans Tandläkarmottagning
      • Trollhättan, Svezia, 46185
        • Käk-kirurgiska Kliniken, Näl

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Male or female subjects aged >18 years
  • Subjects should be willing to take part, able to understand the information given to them, and give written consent
  • Subject diagnosed with partial edentulism and who needs at least one dental implant in the posterior upper jaw i.e. premolars to first molar. The same subject may also need implants in the posterior mandible (premolars to first molar region)

Exclusion Criteria:

  • Suspected to be immunocompromised or are taking immunosuppressant
  • Current participation in another clinical investigation or participation within the last 6 months
  • Known sensitivity/allergies to any of the test materials or any of their ingredients, such as bisphosphonate, titanium or human fibrinogen
  • Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, or psychiatric disease, hypercalcaemia, previous or ongoing malignancy in the head and neck region or uncontrolled diabetes type I which in the opinion of the Investigator, would compromise the safety of the subject or affect the outcome of the investigation
  • Pregnant and lactating females or those actively seeking to become pregnant in the next 3 months
  • Previous (last 5 years) or on-going Bisphosphonate or Denosumab treatment
  • Significant marginal bone loss prior to implant insertion requiring bone grafting or bone graft substitute
  • Subject with extraction(s) performed in the position of implant placement within the last 2 months
  • Subject with need of >6 implants or a full bridge
  • The final prosthetic construction in need of support from neighbouring teeth
  • Known drug or alcohol abuse
  • Subjects only needed implant(s) in the posterior mandible region

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

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Zolidd One ExHex
Coated titanium implant
Dispositivo: Zolidd One ExHex
Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
Dispositivo: One ExHex
Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
Comparatore fittizio: One ExHex
Uncoated titanium implant
Dispositivo: Zolidd One ExHex
Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
Dispositivo: One ExHex
Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the "Index Implant" Comparing Coated and Uncoated Implants
Lasso di tempo: 12 weeks

The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the "index implant" between coated and uncoated implants.

An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100

1 No stability 100 stability The aim is to get as close to a 100 as possible
12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12
Lasso di tempo: week 8 and week 12

To compare absolute ISQ (Implant Stability Quotient) highest values between coated and uncoated "index implants" at week 8 and week 12 after implantation An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100

1 No stability 100 stability Aim its to get close to 100
week 8 and week 12
Incidence of Post-surgery Complications and Adverse Events
Lasso di tempo: Day1 to week 12
To compare safety as assessed by complications post-surgery and any other adverse event up to week 12 between all coated and all uncoated implants
Day1 to week 12
Change in ISQ (Implant Stability Quotient) Highest Value for the "Index Implant"
Lasso di tempo: Day 1 to week 8

To compare change in stability from day 1 to week 8 between the coated and the uncoated "index implants" An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100

1 No stability 100 stability The aim is to get as close to a 100 as possible
Day 1 to week 8
Change in ISQ Highest Value for All Other Implants
Lasso di tempo: week 8 and week 12

To compare change in stability from day 1 to week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100

1 No stability 100 stability
week 8 and week 12
Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants
Lasso di tempo: Week 8 and 12

To compare absolute ISQ (Implant Stability Quotient) highest value at week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100

1 No stability 100 stability
Week 8 and 12
Change in Marginal Bone Height for All Other Implants
Lasso di tempo: week 8 and 12
To compare change in marginal bone height between all coated and all uncoated implants from at week 8 and 12 The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)
week 8 and 12
Post-surgical Complications and Other Adverse Events (AEs) for All Implants
Lasso di tempo: month 24
To compare safety as assessed by complications post-surgery and other adverse events up to month 24 post-implantation visit between all coated and all uncoated implants
month 24
Survival Rate for All Implants
Lasso di tempo: 24 months
To compare survival rate of implants up to 24 months between all coated and all uncoated implants
24 months
Change in Marginal Bone Height for All Implants
Lasso di tempo: Day 1, month 12 and 24
To compare change in marginal bone height from day 1 to month 12 and 24 between all coated and all uncoated implants The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)
Day 1, month 12 and 24
Occurrence of Signs Associated With Peri-implantitis for All Implants
Lasso di tempo: Month 12 and 24
To compare peri-implantitis frequency at 12 and 24 months between all coated and all uncoated implants Ocular assessment of redness and swelling this is an overall judgement of peri-implantitis
Month 12 and 24

Collaboratori e investigatori

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

Sponsor

Addbio AB

Investigatori

  • Investigatore principale: Christer Dahlin, DDS, PhD, Käk kirurgiska kliniken NÄL, Trollhättan, Sweden

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 settembre 2017

Completamento primario (Effettivo)

30 luglio 2020

Completamento dello studio (Effettivo)

1 ottobre 2020

Date di iscrizione allo studio

Primo inviato

13 settembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

13 settembre 2017

Primo Inserito (Effettivo)

14 settembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 gennaio 2022

Ultimo verificato

1 gennaio 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ADD-001

Piano per i dati dei singoli partecipanti (IPD)

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

NO

Descrizione del piano IPD

Not planned at the moment

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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