Dental Implants, Single-toothNCT07427602
Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals
An observational study of Dental Implants, Single-tooth and Immediate Dental Implant Placement, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants, Single-tooth, Immediate Dental Implant Placement, Crown
- What is being tested?
- dental implant with prefabricated provisional restoration
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2026to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Reference intraoral radiograph not available in the medical record
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9700RB
Henny JA Meijer, Professor doctor, +31503616161, h.j.a.meijer@umcg.nl
Meijer, h.j.a.meijer@umcg.nl
About this study
Official title: Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals: A Retrospective Case Series Study
- 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).
Read the detailed description
BACKGROUND
- Introduction and rationale 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 (El Ghoul \& Chidiac, 2012). It was shown that good esthetic results can be achieved with immediate provisionalization of single-tooth implants placed immediately after failing tooth removal (Zuiderveld EG, Meijer HJA, Gareb B, Vissink A, Raghoebar GM, 2024; Donker VJJ, Raghoebar GM, Slagter KW, Hentenaar DFM, Vissink A, Meijer HJA, 2024).
Popularity of immediate implant loading is related to evolving society factors, including more demanding patients and a wish for direct treatment (Huynh-Ba, Oates, \& Williams, 2018). Recent developments in the digital workflow in implant dentistry made treatment planning and fabrication of a provisional restoration before implant placement possible, thus making the treatment more predictable for the clinician and even further shortening the treatment duration. Until date, limited studies have been described investigating immediate provisionalization of single-tooth implants placed immediately after failing tooth removal in the esthetic maxillary zone using a provisional restoration fabricated before implant placement.
- 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.
- Being tested
- dental implant with prefabricated provisional restoration
- Keywords
- Immediate implant placement, Maxillary esthetic region, Prefabricated provisional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant with prefabricated provisional restorationDevice
prefabricated provisional restoration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: dental implant with prefabricated provisional restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Implant and restoration survival
Percentage of implants and restorations present at follow-up time point
Measured: Through study completion, an average of 1 year
Patient satisfaction
Patient satisfaction measured on a Visual Analogue Scale. Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied).
Measured: 1 year
Plaque score
Plaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)
Measured: 1 year
Gingival score
Health of peri-implant mucosa described by Gingival index from 0 to 3. Minimum = 0 (healthy mucosa); Maximum = 3 (very infected mucosa).
Measured: 1 year
Pocket depth
Probing depth in the peri-implant sulcus in millimeters measured with a periodontal probe.
Measured: 1 year
Bleeding score
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implants, Single-toothStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427602
- Sponsor's protocol ID
- Prefabricated provisionals
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals: A Retrospective Case Series Study
- ClinicalTrials.gov ID
- NCT07427602
- Acronym / sponsor ID
- Prefabricated provisionals
- Keywords
- Immediate implant placement, Maxillary esthetic region, Prefabricated provisional
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Detailed description
BACKGROUND
- Introduction and rationale 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 (El Ghoul \& Chidiac, 2012). It was shown that good esthetic results can be achieved with immediate provisionalization of single-tooth implants placed immediately after failing tooth removal (Zuiderveld EG, Meijer HJA, Gareb B, Vissink A, Raghoebar GM, 2024; Donker VJJ, Raghoebar GM, Slagter KW, Hentenaar DFM, Vissink A, Meijer HJA, 2024).
Popularity of immediate implant loading is related to evolving society factors, including more demanding patients and a wish for direct treatment (Huynh-Ba, Oates, \& Williams, 2018). Recent developments in the digital workflow in implant dentistry made treatment planning and fabrication of a provisional restoration before implant placement possible, thus making the treatment more predictable for the clinician and even further shortening the treatment duration. Until date, limited studies have been described investigating immediate provisionalization of single-tooth implants placed immediately after failing tooth removal in the esthetic maxillary zone using a provisional restoration fabricated before implant placement.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement with prefabricated provisional | – | Device: dental implant with prefabricated provisional restorationpatients with immediate implant placement after removal of failing tooth in the maxillary esthetic region and with immediate placement of a prefabricated provisional restoration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- The patient is 18 years or older;
Key exclusion criteria (1 listed)
- Reference intraoral radiograph not available in the medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental implant with prefabricated provisional restorationprefabricated provisional restoration | Device | immediate implant placement with prefabricated provisional |
Primary outcome
Change in peri-implant marginal bone level
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
6 secondary outcomes
Implant and restoration survival
Time frame: Through study completion, an average of 1 year
Patient satisfaction
Time frame: 1 year
Plaque score
Time frame: 1 year
Gingival score
Time frame: 1 year
Pocket depth
Time frame: 1 year
Bleeding score
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, Single-tooth and Immediate Dental Implant Placement, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henny JA Meijer, Professor doctor (+31503616161, h.j.a.meijer@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peri-implant marginal bone level (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.