Dental Implant
Conditions
Keywords
Clinical Research, Dental Implant, Digital Workflow, Patient-Reported Outcome Measures (PROMs), Crowns, Functional Implant Prosthodontic Score (FIPS)
Brief summary
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.
Interventions
PROCEDURETreatment of implant single crown
Digital or Conventional Workflows for treatment of implant single crown and materials used.
Sponsors
ITI International Team for Implantology, Switzerland
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes Assessor received only data without participant group assigned after the intervention was done by a investigator
Intervention model description
Digital and conventional workflows for treatment of implant single crowns, and also the material used.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire | 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). |
| Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional implant prosthodontic score (FIPS) | 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). |
Countries
Thailand
Outcome results
None listed