Narrow Implants Vs Standard Implants With Simultaneous GBR

NCT06168500 | Completed

• 1 other identifier: PER-ECL-2018-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Narrow Implant

Outcome Measures

Primary Outcomes (1)

• Marginal bone level difference

  To assess the MBL, each radiograph must register the most coronal aspect of the bone crest (BC) at mesial and distal to the implant, the position of the implant shoulder (IS) and the first bone to implant contact (FBiC). The marginal bone crest level (MBL) will be measured by calculating the distance between BC and IS. MBL will be considered negative when position of BC is coronal to IS, positive when position BC is apical to IS.

  The changes in MBL will be registered at 8 weeks, 6 months, 12 months, and 3 years.

Secondary Outcomes (13)

• Patient related outcomes

  At 1, 2 and 12 weeks

• Patient Related Outcomes

  At 1, 2 and 12 weeks

• Patient Related Outcomes

  At 7 days

• Patient Related Outcomes

  At 7 days

• Implant survival criteria:

  12 months

Study Arms (2)

Test Group

EXPERIMENTAL

Procedure: Test group; Procedure: Control group

Control group

EXPERIMENTAL

Procedure: Test group; Procedure: Control group

Interventions

Test group PROCEDURE

3.0mm diameter implant

Control group; Test Group

Control group PROCEDURE

4.0 diameter implant + guided bone regeneration

Control group; Test Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Klockner Implant System S.A.: collaborator

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Dental Surgery

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 13, 2023
• Study Start: July 12, 2021
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2025
• Last Updated: March 11, 2026

Record last verified: 2024-05

Locations

ES (1)