Immediate Loading of Implants in the Aesthetic Zone Using Three-dimensionally Printed Provisional Crowns: a 1-year Prospective Case Series Study

NCT07629752 | Not Yet Recruiting

• 1 other identifier: Printed provisional crowns
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• Background There is a growing tendency to place a provisional crown immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better aesthetic outcomes. It was shown that good esthetic results can be achieved on the long term with immediate provisionalization of single-tooth implants placed in either fresh extraction sockets or after alveolar ridge preservation/reconstruction in the maxillary esthetic zone. One recent development in three-dimensional printing is digital press stereolithography (DPS), which overcomes the challenges of printing highly-filled viscous materials. This enables the use of more durable materials than traditional three-dimensionally printed provisional crowns and allows for rapid additive production of prosthetic restorations. Until date, no studies have been described investigating immediate loading of implants in the aesthetic zone using three-dimensional DPS-printers and their impact on patient-satisfaction.
• Main research question The purpose of this one-year prospective case series study is to perform an assessment of patient-reported outcomes of single-tooth implants with immediate provisionalization using three-dimensionally printed provisional crowns.
• Design (including population, confounders/outcomes) The study design is a prospective, single-arm observational study for evaluation of 30 patients with a failing tooth in the maxillary aesthetic region to be treated with an implant-supported provisional and definitive restoration by means of a provisional and definitive crown. Outcomes: registration of time/complications during the diagnostic/planning/manufacturing process, evaluation of clinical and radiographical performance and aesthetic outcome.
• Expected results Satisfying results for patients and professionals (VAS-scores and PES/WES-scores)

Conditions

Dental Implants, Single-tooth; Crown

Keywords

Implant placement; Immediate provisional

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant marginal bone level Description: 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

  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)

Printed provisional restoration

Patients with implant placement in the maxillary esthetic region and with immediate placement of a printed provisional restoration.

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 missing a tooth in the maxillary esthetic region and indicated to be treated with a dental implant and restoration

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;
• Sufficient healthy and vital bone after alveolar ridge preservation to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability \> 45 Ncm;
• The implant site must be free from infection;
• Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);
• Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic crown;
• The provisional crown can be designed free from occlusal contact;
• The patient is capable of understanding and giving informed consent.

You may not qualify if:

• Medical and general contraindications for the surgical procedures;
• Presence of an active and uncontrolled periodontal disease;
• Bruxism;
• Smoking
• A history of local radiotherapy to the head and neck region.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

Central Study Contacts

Henny J A Meijer, Professor doctor

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)