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NCT Number: NCT07427602

Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals

* 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location contact

Henny JA Meijer, Professor doctor

CONTACT

[email protected]

+31503616161

Henny JA Meijer, Professor doctor

PRINCIPAL_INVESTIGATOR

Meijer

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dental implant with prefabricated provisional restoration

Device

prefabricated provisional restoration

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Patient satisfaction

    Time frame: 1 year

    Patient satisfaction measured on a Visual Analogue Scale. Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied).

  3. Plaque score

    Time frame: 1 year

    Plaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)

  4. 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).

  5. Pocket depth

    Time frame: 1 year

    Probing depth in the peri-implant sulcus in millimeters measured with a periodontal probe.

  6. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Henny JA Meijer, Professor doctor

CONTACT

[email protected]

+31503616161

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Immediate Implant Placement and Immediate Restoration With Prefabricated Provisionals: A Retrospective Case Series Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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