Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals

Official title

Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals: A Retrospective Case Series Study

Overview

* Background * There is a growing tendency to place a provisional restoration immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better esthetic outcomes. Provisional restorations can be made either chair-side or in the dental laboratory after implant placement. Nowadays, digital planning makes it possible to fabricate the provisional restoration before implant surgery. The advantage of this technique is that the treatment procedure of placement of the provisional restoration immediately after implant placement is much less time consuming for the patient and due to its machined polished character possibly beneficial for soft tissues. * Main research question The aim of this retrospective case series study, with full digital workflow, is to evaluate single tooth implant treatment after immediate implant placement in the maxillary aesthetic region, with respect to registration of possible complications during the time of placement and evaluation of the prefabricated provisional registration and evaluation of clinical and radiographical performance and aesthetic outcome with the definitive restoration after at least 1 year in function. * Design (including population, confounders/outcomes) The study design is a retrospective, single-arm observational study for evaluation of 50 patients with a failing tooth in the maxillary aesthetic region, which were treated with an implant-supported provisional and definitive restoration by means of a digital workflow. Outcomes: registration of possible complications during the time of placement and evaluation of the provisional registration and evaluation of clinical and radiographical performance and aesthetic outcome with the definitive restoration. * Expected results Satisfying results for patients and professionals (VAS-scores and PES/WES-scores).

Detailed description

BACKGROUND

• Introduction and rationale There is a growing tendency to place a provisional restoration immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better esthetic outcomes (El Ghoul \& Chidiac, 2012). It was shown that good esthetic results can be achieved with immediate provisionalization of single-tooth implants placed immediately after failing tooth removal (Zuiderveld EG, Meijer HJA, Gareb B, Vissink A, Raghoebar GM, 2024; Donker VJJ, Raghoebar GM, Slagter KW, Hentenaar DFM, Vissink A, Meijer HJA, 2024).

Popularity of immediate implant loading is related to evolving society factors, including more demanding patients and a wish for direct treatment (Huynh-Ba, Oates, \& Williams, 2018). Recent developments in the digital workflow in implant dentistry made treatment planning and fabrication of a provisional restoration before implant placement possible, thus making the treatment more predictable for the clinician and even further shortening the treatment duration. Until date, limited studies have been described investigating immediate provisionalization of single-tooth implants placed immediately after failing tooth removal in the esthetic maxillary zone using a provisional restoration fabricated before implant placement.

• Research question The aim of this retrospective case series study, with full digital workflow, is to evaluate single tooth implant treatment after immediate implant placement in the maxillary aesthetic region, with respect to registration of possible complications during the time of placement and evaluation of the prefabricated provisional registration and evaluation of clinical and radiographical performance and aesthetic outcome with the definitive restoration after at least 1 year in function.

Interventions

• Device dental implant with prefabricated provisional restoration
  prefabricated provisional restoration

Primary outcome measures

• Change in peri-implant marginal bone level [Time frame: Through study completion, an average of 1 year]

Secondary outcome measures (6)

• Implant and restoration survival [Time frame: Through study completion, an average of 1 year]
• Patient satisfaction [Time frame: 1 year]
• Plaque score [Time frame: 1 year]
• Gingival score [Time frame: 1 year]
• Pocket depth [Time frame: 1 year]
• Bleeding score [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• The patient is 18 years or older;

• The implant region is an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
• Patient is treated with an immediate implant and an immediate prefabricated provisional restoration;
• The definitive restoration is at least one year in function

Exclusion criteria

• Reference intraoral radiograph not available in the medical record

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Netherlands · 1 center

• University Medical Center Groningen — Groningen

Identifiers

NCT: NCT07427602 · Prefabricated provisionals

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗