Health TrialsbyHealthPanel

Immediate Versus Late Placement

ConditionEsthetics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Ghent

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

at least 18 years old

good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)

presence of a single-rooted tooth in the anterior maxilla (15-25) that needs to be extracted for any reason with at least one neighboring tooth present

at least 3 mm bone available at the apical or palatal aspect of the alveolus to ensure primary implant stability

Disqualifiers

systemic diseases

smoking

untreated periodontal disease

untreated caries lesions

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

    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).

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

    Procedure/Surgery

    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).

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

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 3 interventions
Group B: Test groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Need for soft tissue augmentation (true or false) as judged by a panel of clinicians

The need for soft tissue augmentation is assessed by the 5 clinicians who have not been clinically involved. The treating clinician is excluded since he/she cannot be blinded for the treatment group. The need for soft tissue augmentation is assessed on the basis of clinical pictures, a CBCT image and STL file.

Time frame
6 months

Secondary outcomes

1

Clinician-reported outcome measures

Ease of implant placement (Visual Analogue Scale). Minimum value = 0 (Very easy) Maximum value = 10 (Very difficult)

Time frame
per-op
2

Changes in buccal soft tissue profile

Volumetric analysis with designated software on the basis of IOS (mm). Change in buccal soft tissue profile and the initial buccal soft tissue profile will be aggregated to calculate relative change in buccal soft tissue profile (=absolute change / initial buccal soft tissue profile, percent)

Time frame
pre-op, 6 months, 1 year, 3 years, 5 years
3

Vertical change in midfacial soft tissue level

Analysed with designated software on the basis of IOS (mm)

Time frame
pre-op, 6 months, 1 year, 3 years, 5 years
4

Change in width of the alveolar process

Horizontal measurements with designated software on the basis of CBCT scans (mm)

Time frame
pre-op, 1 year, 5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Ghent

Lead sponsor

Source ClinicalTrials.gov
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