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

21 janvier 2022 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

62

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Zolidd One ExHex
Coated titanium implant
Dispositif: 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.
Dispositif: 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.
Comparateur factice: One ExHex
Uncoated titanium implant
Dispositif: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12
Délai: 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
Délai: 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"
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Addbio AB

Les enquêteurs

  • Chercheur principal: Christer Dahlin, DDS, PhD, Käk kirurgiska kliniken NÄL, Trollhättan, Sweden

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2017

Achèvement primaire (Réel)

30 juillet 2020

Achèvement de l'étude (Réel)

1 octobre 2020

Dates d'inscription aux études

Première soumission

13 septembre 2017

Première soumission répondant aux critères de contrôle qualité

13 septembre 2017

Première publication (Réel)

14 septembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • ADD-001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Not planned at the moment

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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