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Immediate Versus Late Placement

NCT04741607 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-02

No results posted yet for this study

Summary

Patients in need of a single implant in the premaxilla will be invited to participate in this multicenter randomized controlled trial (RCT). Prior to surgery, a small-field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone dimensions. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'delayed implant placement' and 5 with 'immediate implant placement').

For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated prior to tooth extraction.

In the control group, alveolar ridge preservation is performed following tooth extraction. After a healing period of 4 months, a single implant is installed.

In the test group, a single implant is installed immediately after tooth extraction and ridge preservation is performed by filling the gap between the facial bone wall and the implant surface.

A provisional crown is placed at the day of implant surgery, which is replaced by a permanent one 3m later.

Six months after tooth extraction and subsequent ridge preservation, the need for soft tissue grafting is assessed on the base of predetermined criteria (primary outcome measure). Soft tissue augmentation is performed by inserting a palatal connective tissue graft (CTG) into the buccal mucosa at the implant site.

Secondary outcome measures include 3D hard and soft tissue changes as well as clinical, aesthetic, patient-reported and clinician-reported outcomes.

Conditions

  • Esthetics

Interventions

DEVICE

Implant placement (BLX implant system, Straumann, Basel, Switzerland)

Implants are placed after a healing period of 4 months (delayed implant placement, control group) or immediately after tooth extraction and ridge preservation (immediate implant placement, test group).

PROCEDURE

Ridge preservation (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland)

Ridge preservation is performed by inserting a collagen-enriched DBBM (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland) in the empty extraction socket (delayed implant placement, control group) or by filling the gap between the implant and buccal bone wall (immediate implant placement, test group).

PROCEDURE

Socket seal (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switserland)

The occlusal aspect of the grafted socket in the delayed implant placement/control group is closed with a collagen matrix.

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741607 on ClinicalTrials.gov