- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07629752
Immediate Loading of Implants in the Aesthetic Zone Using Three-dimensionally Printed Provisional Crowns: a 1-year Prospective Case Series Study
• 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)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Henny J A Meijer, Professor doctor
- Phone Number: +31503616161
- Email: h.j.a.meijer@umcg.nl
Study Locations
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Provincie Groningen
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Groningen, Provincie Groningen, Netherlands, 9700RB
- University Medical Center Groningen
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Principal Investigator:
- Henny JA Meijer, Professor doctor
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Contact:
- Henny J A Meijer, Professor doctor
- Phone Number: +31503616161
- Email: h.j.a.meijer@umcg.nl
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Printed provisional restoration
Patients with implant placement in the maxillary esthetic region and with immediate placement of a printed provisional restoration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: Through study completion, an average of 1 year
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Comparison between peri-implant bone level at implant placement and follow-up time point in millimeters measured on intraoral radiographs
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Implant and restoration survival
Time Frame: Through study completion, an average of 1 year
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Percentage of implants and restorations present at follow-up time point
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Through study completion, an average of 1 year
|
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Patient satisfaction
Time Frame: 1 year
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Patient satisfaction measured on a Visual Analogue Scale.
Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied).
|
1 year
|
|
Plaque score
Time Frame: 1 year
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Plaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)
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1 year
|
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Gingival score
Time Frame: 1 year
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Health of peri-implant mucosa described by Gingival index from 0 to 3. Minimum = 0 (healthy mucosa); Maximum = 3 (very infected mucosa).
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1 year
|
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Pocket depth
Time Frame: 1 year
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Probing depth in the peri-implant sulcus in millimeters measured with a periodontal probe.
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1 year
|
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Bleeding score
Time Frame: 1 year
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Bleeding 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).
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1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Printed provisional crowns
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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