Narrow Implants Vs Standard Implants With Simultaneous GBR

Universitat Internacional de Catalunya

Status

Enrolling

Conditions

Bone Regeneration

Dental Implant

Narrow Implant

Treatments

Procedure: Control group

Procedure: Test group

Study type

Interventional

Funder types

Other

Identifiers

NCT06168500

PER-ECL-2018-06

Details and patient eligibility

About

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 survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses supported by NDI in the posterior area. They observe a survival rate of 97% and absence of prosthetic complications after the study period time. More recently, Souza et al. performed a prospective randomized split mouth study with 3 years follow-up with the aim of comparing marginal bone level, implant survival and success rates and prosthesis success rates of NDI and SDI placed in the posterior area of the mandible to support single prosthesis. They observed an implant survival rate of 100% for both groups at 1 and 3 years. The prosthesis success rate at 1 and 3 years was of 95.4% and 100%, respectively.

NDI present a high survival rate on the evaluated studies. Therefore, the aim of the first study is to compare the patient related outcomes, implants and prostheses success and survival rates of pure titanium NDI versus SDI with simultaneous bone regeneration in narrow alveolar ridges at posterior areas of the maxilla and the mandible.

Enrollment

26 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.