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NCT Number: NCT04986761

PROMs Comparing Digital & Conventional Workflows

This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside digital workflow (Test) and a conventional protocol (Control). The primary outcome was subjective patient perception in terms of PROMs comparing digital and conventional impression techniques as well as patients' satisfaction related to the final implant restoration among difference workflows and materials. The secondary outcome was to investigate the objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS). The null-hypothesis of this RCT was that both workflows and the two materials for the monolithic implant restorations had comparable results with respect to the defined outcomes.

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Key information

Conditions

Dental Implant

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Mahidol University

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-The participants are in the age of more than 20 years old and not more than 80 years old.

  • The participants who have a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) placed in single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
  • The participants' general medical health is healthy or has a well-controlled systemic disease.
  • The participants' general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.

Exclusion criteria

  • The participants who are smoking more than 10 cigarettes per day.
  • The participants with pregnancy.
  • The participants with a psychiatric disorder
  • The participants with a history of radiation therapy at the head and neck area.
  • The participants with a history of chemotherapy.
  • The participants with bony pathologies such as osseous dysplasia, odontogenic cyst or tumor, etc.

Treatment and study plan

Treatment of implant single crown

Procedure

Digital or Conventional Workflows for treatment of implant single crown and materials used.

Primary outcomes

  1. Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire

    Time frame: After impression, At first visit within 30 minutes

    After impression-taking, questionnaires were handed out to the participants to evaluate PROMs via visual analog scales (VAS). Six categories were assessed: (1) overall treatment time of impression-taking procedure (0=unsatisfactory to 10=excellent); (2) convenience level of the impression technique (0=unsatisfactory to 10=excellent); (3) anxiety level of impression technique (0=low to 10=high); (4) bad taste and (5) nausea caused by the impression (each 0=no sensation to 10=a lot of sensation); and (6) pain during impression-taking procedure (0=no pain to 10=a lot of pain).

  2. Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire

    Time frame: 1 week after prosthesis delivery

    Patients were requested to score their feeling on screw-retained monolithic implant crowns in a 10cm VAS one week after delivery of the final implant crowns. The level of patients' satisfaction was measured in four categories: (1) perception of the overall treatment outcome (0=unsatisfactory to 10=excellent); (2) opinion on the function of the restoration (0=unsatisfactory to 10=excellent); (3) esthetic perspective (0=unsatisfactory to 10=excellent), and (4) ease of oral hygiene care (0=unsatisfactory to 10=excellent).

Secondary outcomes

  1. Functional implant prosthodontic score (FIPS)

    Time frame: Prosthesis delivery visit, an average of 2 weeks after first visit for impression procedure

    objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS).

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • ITI International Team for Implantology, Switzerland

Registry information

Official study title

Patient-reported Outcome Measures (PROMs) Comparing Digital and Conventional Workflows for Treatment With Single-unit Implant Restorations: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2021
Registry last updated
Aug 4, 2021

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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