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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1
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195