Narrow Implants Vs Standard Implants With Simultaneous GBR

NCT ID: NCT06168500

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2025-12-28

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 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.

Conditions

Narrow Implant; Dental Implant; Bone Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Group

Group Type: EXPERIMENTAL

Test group

Intervention Type: PROCEDURE

3.0mm diameter implant

Control group

Intervention Type: PROCEDURE

4.0 diameter implant + guided bone regeneration

Control group

Group Type: EXPERIMENTAL

Test group

Intervention Type: PROCEDURE

3.0mm diameter implant

Control group

Intervention Type: PROCEDURE

4.0 diameter implant + guided bone regeneration

Interventions

Test group

3.0mm diameter implant

Intervention Type: PROCEDURE

Control group

4.0 diameter implant + guided bone regeneration

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Klockner Implant System S.A.

UNKNOWN

Sponsor Role: collaborator

Botiss Medical AG

OTHER

Sponsor Role: collaborator

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo González Terrats

Doctor Dental Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rodrigo González Terrats, Dentistry

Role: CONTACT

rodrigt_11@uic.es

0034618265213

Facility Contacts

Rodrigo González Terrats, Dentistry

Role: primary

Other Identifiers

PER-ECL-2018-06

Identifier Type: -

Identifier Source: org_study_id