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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07629752
Enrollment
30
Registered
2026-06-05
Start date
2026-07-01
Completion date
2027-07-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crown, Dental Implants, Single-tooth

Keywords

Implant placement, Immediate provisional

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)

Detailed description

• Introduction and rationale 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 (El Ghoul & Chidiac, 2012). 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 (Donker et al., 2024; Meijer et al., 2025). The popularity of immediate implant loading is related to evolving society factors, including more demanding patients and a wish for direct treatment (Huynh-Ba et al., 2018). Developments in the digital workflow in implant dentistry made treatment planning with the use of intra-oral scans and cone-beam computed tomography (CBCT) and fabrication of a provisional restoration using three-dimensional printers for additive manufacturing possible, further shortening the treatment duration. It was shown that patients prefer intra-oral scanning over analog impression taking (Schepke et al., 2015). Thus, it can be assumed that a digital workflow has advantages over an analog workflow for both the clinician and patients. 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 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. 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, with respect to registration of time/complications during the diagnostic/planning/manufacturing process, evaluation of clinical and radiographical performance and aesthetic outcome.

Interventions

None listed

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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; * 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
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 yearThrough study completion, an average of 1 yearComparison between peri-implant bone level at implant placement and follow-up time point in millimeters measured on intraoral radiographs

Secondary

MeasureTime frameDescription
Implant and restoration survivalThrough study completion, an average of 1 yearPercentage of implants and restorations present at follow-up time point
Patient satisfaction1 yearPatient satisfaction measured on a Visual Analogue Scale. Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied).
Plaque score1 yearPlaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)
Gingival score1 yearHealth of peri-implant mucosa described by Gingival index from 0 to 3. Minimum = 0 (healthy mucosa); Maximum = 3 (very infected mucosa).
Pocket depth1 yearProbing depth in the peri-implant sulcus in millimeters measured with a periodontal probe.
Bleeding score1 yearBleeding in peri-implant sulcus after probing measured with a Bleeding index from 0 to 3. Minimum = 0 (no bleeding after probing); Maximum = 3 (abundance amount of bleeding after probing).

Countries

Netherlands

Contacts

CONTACTHenny J A Meijer, Professor doctor
h.j.a.meijer@umcg.nl+31503616161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026