Status:

RECRUITING

Narrow Implants Vs Standard Implants With Simultaneous GBR

Lead Sponsor:

Universitat Internacional de Catalunya

Collaborating Sponsors:

Klockner Implant System S.A.

Botiss Medical AG

Conditions:

Narrow Implant

Dental Implant

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

NDI represent an advisable treatment option when the mesio-distal space is compromised. In a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survi...

Eligibility Criteria

Inclusion

  • Patients:
  • 18 years old
  • Healthy periodontal status (absence of generalized probing pocket depth (PPD) \<4mm)
  • Oral hygiene levels (FMPS \<20 and FMBS \<20)
  • Site:
  • Ridge width of \>5mm and \<6.5mm and minimum bone height of 10mm prior evaluation on a CBCT scan
  • Presence of antagonistic natural tooth or fixed prosthetic restoration
  • Presence of adjacent teeth
  • One maxillary or mandibular premolars
  • Minimum of 3mm of keratinized tissue over the bone crest (20)
  • Bone regeneration within the limits of the prosthetic restoration.
  • Implants:
  • Unitary prosthesis
  • Screwed retained restorations

Exclusion

  • Patients
  • Presence of active chronic or aggressive periodontal disease
  • Presence of systemic disease which contraindicate surgery (patients with an ASA ≥ 3)
  • Drugs or medications which may alter the results (chronic intake of analgesic medication)
  • Smokers (\>10cig/day)
  • Pregnant women
  • History of head and neck radiotherapy.
  • Site
  • Anterior area (from 1.3 to 2.3 and from 3.3 to 4.3) and molar area
  • Previous guided bone regeneration
  • Location where there is not sufficient restorative space (mesio-distally \<8mm for every restoration unit and \<5mm from the bone crest to the antagonist)
  • Implant dehiscence of more than 2/3 of the implant.
  • Implant
  • Implants which cannot be restored with a screwed restoration
  • Implants which doesn't reach a manual implant stability
  • implants which after placement doesn't reach a favourable position according to the restoration.

Key Trial Info

Start Date :

July 12 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 28 2025

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT06168500

Start Date

July 12 2021

End Date

December 28 2025

Last Update

May 29 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain, 08195