- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427602
Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals
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).
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Henny JA Meijer, Professor doctor
- Phone Number: +31503616161
- Email: h.j.a.meijer@umcg.nl
Study Locations
-
-
Provincie Groningen
-
Groningen, Provincie Groningen, Netherlands, 9700RB
- University Medical Center Groningen
-
Contact:
- Henny JA Meijer, Professor doctor
- Phone Number: +31503616161
- Email: h.j.a.meijer@umcg.nl
-
Contact:
- Meijer
- Email: h.j.a.meijer@umcg.nl
-
Principal Investigator:
- Henny JA Meijer, Professor doctor
-
-
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;
- Patient is treated with an immediate implant and an immediate prefabricated provisional restoration;
- The definitive restoration is at least one year in function
Exclusion Criteria:
- Reference intraoral radiograph not available in the medical record
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
prefabricated provisional restoration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant and restoration survival
Time Frame: Through study completion, an average of 1 year
|
Percentage of implants and restorations present at follow-up time point
|
Through study completion, an average of 1 year
|
|
Patient satisfaction
Time Frame: 1 year
|
Patient satisfaction measured on a Visual Analogue Scale.
Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied).
|
1 year
|
|
Plaque score
Time Frame: 1 year
|
Plaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)
|
1 year
|
|
Gingival score
Time Frame: 1 year
|
Health of peri-implant mucosa described by Gingival index from 0 to 3. Minimum = 0 (healthy mucosa); Maximum = 3 (very infected mucosa).
|
1 year
|
|
Pocket depth
Time Frame: 1 year
|
Probing depth in the peri-implant sulcus in millimeters measured with a periodontal probe.
|
1 year
|
|
Bleeding score
Time Frame: 1 year
|
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). |
1 year
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prefabricated provisionals
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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