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Completed

NCT Number: NCT03234868

Benefit of the Digital Workflow for Screw-retained Single Implant Restorations

The aim of this research project is emphasize the benefit of the digital workflow compared to conventional impressions and crown processing with standard la procedures. The objectives of the present study are to measure and compare the global cost, the time spent in the dental chair and in the lab and the fit of both digital and conventional workflow. Additionally, patient centered outcomes will be recorded.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject must have voluntarily signed the informed consent form before any study related action
  • Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
  • Men/Women
  • In good systemic health (ASA I/ II)
  • Present with no contra indication against oral surgical interventions
  • Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
  • At least 10 mm of bone in the vertical dimension
  • At least 6 mm of bone in the bucco-lingual dimension.
  • No need for bone augmentation procedure in any of the dimensions
  • Full mouth plaque score (FMPI) lower or equal than 25%

Exclusion criteria

  • Autoimmune disease require medical treatment
  • Medical conditions requiring prolonged use of steroids
  • Use of Bisphosphonate intravenously or more then
  • Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
  • Current pregnancy or breastfeeding women
  • Alcoholism or chronically drug abuse
  • Immunocompromised patients
  • Uncontrolled Diabetes
  • Smokers
  • Prisoners

Treatment and study plan

Impression procedure

Device

Each patient will go through both type of impression during single appointment: first the digital impression and then the conventional one (to avoid residual impression materials for the optical impressions). The time necessary for each procedure will be recorded.

Crown manufacturing procedures

Device

Test and control implant crowns will be screw-retained on a multi-unit abutment. The conventional crown will be made of a Zirconia framework veneered with cosmetic ceramics directly screwed on the multi-unit platform (no titanium base). The experimental crown will be made in full zirconia and designed in the TRIOS software.

Primary outcomes

  1. Fit of the crowns

    Time frame: 1 year

    To measure this parameter we will focus on interproximal fit and occlusion. Interproximal contact points will be checked with dental floss.

Secondary outcomes

  1. Time consumption at the dental chair

    Time frame: 1 year

    Numbers of appointment needed for each procedure will be counted and each one of them will be timed (from the unscrewing of the healing abutment until its replacement).

  2. Time consumption in the lab

    Time frame: 1 year

    The time needed by the lab for manufacturing the crowns will be evaluated by timing all the different steps.

  3. Global cost

    Time frame: 1 year

    Considering the time spent by the dentist and the lab technician, the cost of the optical impression system, of impression materials, of impression trays, of scan bodies and of impression copings, the final cost of each crown will be compared.

  4. Esthetical aspect

    Time frame: 1 year

    A VAS evaluation of the esthetic properties (scoring from zero to ten each crown) will be achieved after the placement of each crown.

  5. Patient centered outcomes

    Time frame: 1 year

    A questionnaire based on VAS scales will be given out and filled by the patients. Thus it will be possible to estimate which of both impressions is less unpleasant for them (questionnaire are in developement).

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2017
Registry last updated
Jul 31, 2017

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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