Clinical trial NCT04986761: PROMs Comparing Digital & Conventional Workflows
Official title: Patient-reported Outcome Measures (PROMs) Comparing Digital and Conventional Workflows for Treatment With Single-unit Implant Restorations: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Keywords: Clinical Research
Dental Implant
Digital Workflow
Patient-Reported Outcome Measures (PROMs)
Crowns
Functional Implant Prosthodontic Score (FIPS)
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: ITI International Team for Implantology, Switzerland
First posted: 2021-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Digital and conventional workflows for treatment of implant single crowns, and also the material used.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire
timeFrame: After impression, At first visit within 30 minutes
measure: Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire
timeFrame: 1 week after prosthesis delivery
Secondary outcomes:
measure: Functional implant prosthodontic score (FIPS)
timeFrame: Prosthesis delivery visit, an average of 2 weeks after first visit for impression procedure
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of dentistry, Mahidol University
Study officials:
References:
citation: Joda T, Bragger U. Patient-centered outcomes comparing digital and conventional implant impression procedures: a randomized crossover trial. Clin Oral Implants Res. 2016 Dec;27(12):e185-e189. doi: 10.1111/clr.12600. Epub 2015 Apr 12.