Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals

NCT07427602 | Not Yet Recruiting

• 1 other identifier: Prefabricated provisionals
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

• 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).

Conditions

Dental Implants, Single-tooth; Immediate Dental Implant Placement; Crown

Keywords

Immediate implant placement; Maxillary esthetic region; Prefabricated provisional

Outcome Measures

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

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Implant and restoration survival

  Through study completion, an average of 1 year

• Patient satisfaction

  1 year

• Plaque score

  1 year

• Gingival score

  1 year

• Pocket depth

  1 year

Study Arms (1)

immediate implant placement with prefabricated provisional

patients with immediate implant placement after removal of failing tooth in the maxillary esthetic region and with immediate placement of a prefabricated provisional restoration.

Device: dental implant with prefabricated provisional restoration

Interventions

dental implant with prefabricated provisional restoration DEVICE

prefabricated provisional restoration

immediate implant placement with prefabricated provisional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Reference intraoral radiograph not available in the medical record

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Henny JA Meijer, Professor doctor

CONTACT

+31503616161; h.j.a.meijer@umcg.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: February 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)