Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

* 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Reference intraoral radiograph not available in the medical record

Trial population

Patient is treated with an immediate implant and an immediate prefabricated provisional restoration; the definitive restoration is at least one year in function

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • dental implant with prefabricated provisional restoration

    Device

    prefabricated provisional restoration

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: immediate implant placement with prefabricated provisional1 intervention

Trial outcomes

Primary outcomes

1

Change in peri-implant marginal bone level

Comparison between peri-implant bone level at implant placement and follow-up time point in millimeters measured on intraoral radiographs

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Implant and restoration survival

Percentage of implants and restorations present at follow-up time point

Time frame
Through study completion, an average of 1 year
2

Patient satisfaction

Patient satisfaction measured on a Visual Analogue Scale. Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied).

Time frame
1 year
3

Plaque score

Plaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)

Time frame
1 year
4

Gingival score

Health of peri-implant mucosa described by Gingival index from 0 to 3. Minimum = 0 (healthy mucosa); Maximum = 3 (very infected mucosa).

Time frame
1 year

Other outcomes

Sponsors and contacts

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