Edentulous JawNCT03992300
Comparison of Full-arch Implant-supported Frameworks From an Intraoral Scanning or From a Conventional Impression
A study testing Clinical adjustment in people with Edentulous Jaw, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Purpose: To determine if adjustment of full-arch zirconia frameworks processed on a model obtained with an intraoral scanner and an auxiliary device is not inferior to that of identical frameworks obtained from an elastomeric impression. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Clinical adjustment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 28 May 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ·Patients with four or more implants already osseo-integrated ready to rehabilitate with a full-arch implant-supported framework of 10 or more units. ·Upper or lower jaw.
Who cannot join
- Implants not suitable for multiunit abutments.
- More than six implants.
- Peri-implantitis present in any implant.
- Need of a removable prosthesis.
- Patients unable to understand the purpose of the study.
- Patients with a restorative space higher than 15 milimiters.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinica Universitaria d'Odontologia
Sant Cugat Del Vallés, Barcelona, 08195
About this study
Official title: Comparison of Accuracy and Timing Parameter of Digital and Conventional Impression Techniques on Fully Edentulous Jaws: an in Vivo Study
Purpose: To determine if adjustment of full-arch zirconia frameworks processed on a model obtained with an intraoral scanner and an auxiliary device is not inferior to that of identical frameworks obtained from an elastomeric impression.
Materials and methods: Eight consecutive patients ready for a full-arch rehabilitation on already osseointegrated implants were selected. Two sets of impressions were taken, one open tray with polyether and splinted impression copings and a second one with an intraoral scanner. A verification plaster jig was used for the elastomeric impression and a prefabricated auxiliary device was used to adjust the optical intraoral impressions. Two full-zirconia frameworks with the same design were processed and tested on the patient by two independent calibrated operators. Accuracy of both frameworks was measured by calibrated blinded operators, who determined tactile adjustment, Sheffield test, radiographic adjustment, and screwing torque. Overall perception of adjustment was used to determine the better framework to be delivered to the patient.
Hº: Frameworks obtained from an impression taken with an intraoral scanner are not inferior in accuracy to those obtained from a conventional elastomeric impression
Read the detailed description
Eight consecutive patients ready for a full-arch rehabilitation on previously osseointegrated implants, and who had received an immediately loaded prosthesis, were selected. All implants had multiunit abutments placed on top. Cases from 4 to 6 implants were accepted, either upper or lower arches. Three sets of impressions were taken to each patient:
Conventional impression:
Open tray impression copings were screwed on top of all implants in the arch using a torque wrench set at 10 N/cm. Impression copings were splinted by means of Triad Gel clear resin, with an at least 3mm diameter in the resin connectors. Once the resin was photo-polymerized a cut was done in the centre of each connection with a 0.3 mm bur, to eliminate possible stress in the structure, and then it was splinted again with a drop of Triad Gel in each cut. A polyether impression was taken by means of a perforated plastic tray, and a master model was fabricated following the manufacturer's instructions. A plaster verification jig was fabricated on the model. After one week the patient came to the dental clinic where vertical dimension of occlusion was determined and the plaster key was screwed in the patient mouth to check passivity. In case the key had been fractured, a new impression would have been taken, and if not, final prosthesis could be processed.
Optical impression:
An impression of the antagonist and an impression of the edentulous arch with the healing abutments in place were taken by means of an optical scanner following the manufacturers protocol. The position of the implants was marked in the working standard tessellation language (STL) model, and the software cut a circle on top of those areas. The files were copied, and two datasets were obtained.
Scan-bodies were placed on top of each multiunit abutment, the first STL dataset was open and a second impression was taken, so that the scan-bodies were positioned on the working file.
Scan-bodies were then removed from the patient mouth, and temporary copings were placed on top of each multiunit abutment. A MedicalFit device was selected, and holes were drilled in the position of the implants until it fitted on top of all the cylinders. Cylinders were then splinted to MedicalFit device by means of Triad Gel clear. The device was then removed from the patient mouth and scan implant replicas were placed at the bottom of the metal cylinders. Finally, the device with the scan implant replicas was scanned with an intraoral optical scanner.
The following set of pictures were taken: Rest position, maximum smile (with the scan bodies placed in the mouth), front with retractors (with the scan bodies), and 45º with retractors (also with the scan bodies in place).
All pictures and STL datasets were sent to the dental technician to produce a temporary structure. The STL dataset from the scanning of Medicalfit device used was adjusted to the original STL dataset of the device in the library, and then superimposed to the dataset of the scan-bodies received from us, to allow repositioning of the scan-bodies and to correct possible discrepancies during the intraoral scanning process.
A temporary polymethylmethacrylate (PMMA) framework was delivered by the dental lab and tried in the patient mouth. Corrections were done to adjust occlusion, gingival contour and esthetic parameters where needed. Once esthetic parameters and occlusal scheme were considered correct, a new intraoral scanning was taken with the temporary framework in place. In case changes were done in the gingival contour, scanning of the gingival aspect of the PMMA framework was also done. The PMMA temporary was then left in the patient mouth.
Three pictures were taken with the PMMA framework placed in the mouth: Front full face at rest, front full-face smiling, front full face with separators and full face smiling at 45º.
Clinical adjustment assessment:
After one week two sets of the final prosthesis in full-zirconia were sent from the dental lab, one processed with conventional models and the second fully digital. Both sets were tested in the patient mouth by two calibrated blinded independent operators.
Misfit should be ideally measured in terms smaller than 10 microns, but clinical adjustment is difficult to assess using conventional or quantitative methods. In this research adjustment was assessed following four criteria: passivity in the insertion of the screws, tactile sensation, radiographs and screwing torque:
- A Visual Analogue Scale (VAS) was used to assess the perception of passivity in the insertion of the prosthodontic screws. A ten centimeters line will be shown to the observer. One side of the line represents "perfect passivity", and the other "no passive at all". The observer will mark his passivity perception on the line between the two endpoints. The distance between "no passivity at all" and the mark will defines the passivity perception.
- Examination of the marginal fit with an exploratory probe (#23/3 explorer) under 3,8x magnification. Three possible scores were possible: 0 (no gap perceived when probing), 1 (perception of the gap without entering it) and 2 (the tip of the explorer clearly entered the gap).
- Periapical radiographs were taken with a positioning system to evaluate possible gaps. Five possible scores were possible from 1 to 5, being 1 no gap and increasing 0.15 mm each score until reaching 0.60 mm in score 5.
- Digital photographs were taken with a 105 mm macro lens. The pictures were calibrated with the known height of the framework and the gap was measured. Four possible scores were possible, being 1 no gap and increasing 0.25 mm each score until reaching 0.75 mm in score 5.
- Screwing torque on each abutment was measured with the app software from Ichiropro motor (BienAir, Bienne, Switzerland). All screws were hand screwed and then all but the most distal right were unscrewed. Torque was set at 15 N/cm and speed at 5 rpm. The most right distal screw was tightened first, and then the rest of the screws were tightened starting at the most mesial left, following to the most distal left, and from that to the next neighbor implant until all screws were tightened. The torque-time signature was studied in every screw to determine if the torque started to grow just at the end of the tightening or throughout the process. Three scores were possible: 1 for linear value with a fast increase at end of the tightening, 2 for soft continuous growth with a steeper increase at the end, 3 for steep increase at the beginning of tightening.
Once the assessment of the two frameworks was completed, the framework with better adjustment will be placed in the patient, after assessing the presence of correct occlusion, phonetics and esthetic parameters. The second set will be packed and delivered to the patient as a possible replacement in case of problems in the future.
- Conditions
- Edentulous Jaw
- Being tested
- Clinical adjustment
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical adjustmentDevice
Accuracy of the framework is checked in the patient mouth by tactile perception, screwing torque, Sheffield test and radiography.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral scanning | Experimental | An intraoral scanning is taken. An auxiliary device is used to achieve better accuracy. A zirconia framework is produced Receives: Device: Clinical adjustment |
| Conventional scanning | Active comparator | A conventional elastomeric impression is taken and a zirconia framework is produced Receives: Device: Clinical adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the framework
Overall perception of adjustment of the two frameworks
Measured: one day
Secondary outcomes (4)
Perception of the passivity
A Visual Analogue Scale (VAS) will be used to assess the perception of passivity in the insertion of the prosthodontic screws. A ten centimeters line will be shown to the observer. One side of the line represents "perfect passivity", and the other "no passivity at all". The observer will mark his passivity perception on the line between the two endpoints. The distance between "no passivity at all" and the mark will define the passivity perception.
Measured: 1 day
Optical adjustment
Examination of the marginal fit with an exploratory probe (#23/3 explorer) under 3,8x magnification. Three possible scores were possible: 0 (no gap perceived when probing), 1 (perception of the gap without entering it) and 2 (the tip of the explorer clearly entered the gap).
Measured: 1 day
Radiographic adjustment
Periapical radiographs will be taken with a positioning system to evaluate possible gaps. Five possible scores will be possible from 1 to 5, being 1 no gap and increasing 0.15mm each score until reaching 0.60mm in score 5.
Measured: 1 day
Screwing torque
Screwing torque in each abutment will be measured by means of Ichiropro® motor. The torque/angle signature will be registered and three possible scores will be possible: 1 for linear value with a fast increase at end of the tightening, 2 for soft continuous growth with a steeper increase at the end, 3 for steep increase at the beginning of tightening.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start28 May 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Two frameworks with the same design obtained from two different models (intraoral scanning and conventional impression) are processed and tested in every patient
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Roig Cayón, Universitat Internacional de Catalunya
- Investigators
- MIGUEL ROIG CAYON, MD DDS PHD, Study director, Unversitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992300
- Sponsor's protocol ID
- REST-ECT-2017-03
- Status last verified
- Jun 2019
- First submitted
- 17 Jun 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to publish the data in a paper
Publications
Lee H, So JS, Hochstedler JL, Ercoli C. The accuracy of implant impressions: a systematic review. J Prosthet Dent. 2008 Oct;100(4):285-91. doi: 10.1016/S0022-3913(08)60208-5.
PubMed 18922257al-Turki LE, Chai J, Lautenschlager EP, Hutten MC. Changes in prosthetic screw stability because of misfit of implant-supported prostheses. Int J Prosthodont. 2002 Jan-Feb;15(1):38-42.
PubMed 11887597Jansen VK, Conrads G, Richter EJ. Microbial leakage and marginal fit of the implant-abutment interface. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):527-40.
PubMed 9274082Millington ND, Leung T. Inaccurate fit of implant superstructures. Part 1: Stresses generated on the superstructure relative to the size of fit discrepancy. Int J Prosthodont. 1995 Nov-Dec;8(6):511-6.
PubMed 8595110Sahin S, Cehreli MC. The significance of passive framework fit in implant prosthodontics: current status. Implant Dent. 2001;10(2):85-92. doi: 10.1097/00008505-200104000-00003.
PubMed 11450418Abduo J, Bennani V, Waddell N, Lyons K, Swain M. Assessing the fit of implant fixed prostheses: a critical review. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):506-15.
PubMed 20556249Katsoulis J, Takeichi T, Sol Gaviria A, Peter L, Katsoulis K. Misfit of implant prostheses and its impact on clinical outcomes. Definition, assessment and a systematic review of the literature. Eur J Oral Implantol. 2017;10 Suppl 1:121-138.
PubMed 28944373Assif D, Marshak B, Schmidt A. Accuracy of implant impression techniques. Int J Oral Maxillofac Implants. 1996 Mar-Apr;11(2):216-22.
PubMed 8666454Al-Meraikhi H, Yilmaz B, McGlumphy E, Brantley W, Johnston WM. In vitro fit of CAD-CAM complete arch screw-retained titanium and zirconia implant prostheses fabricated on 4 implants. J Prosthet Dent. 2018 Mar;119(3):409-416. doi: 10.1016/j.prosdent.2017.04.023. Epub 2017 Jul 15.
PubMed 28720339Jemt T. Failures and complications in 391 consecutively inserted fixed prostheses supported by Branemark implants in edentulous jaws: a study of treatment from the time of prosthesis placement to the first annual checkup. Int J Oral Maxillofac Implants. 1991 Fall;6(3):270-6.
PubMed 1813395Klineberg IJ, Murray GM. Design of superstructures for osseointegrated fixtures. Swed Dent J Suppl. 1985;28:63-9. No abstract available.
PubMed 3904064Gibbs SB, Versluis A, Tantbirojn D, Ahuja S. Comparison of polymerization shrinkage of pattern resins. J Prosthet Dent. 2014 Aug;112(2):293-8. doi: 10.1016/j.prosdent.2014.02.006. Epub 2014 Apr 14.
PubMed 24726587Papaspyridakos P, Lal K. Computer-assisted design/computer-assisted manufacturing zirconia implant fixed complete prostheses: clinical results and technical complications up to 4 years of function. Clin Oral Implants Res. 2013 Jun;24(6):659-65. doi: 10.1111/j.1600-0501.2012.02447.x. Epub 2012 Mar 13.
PubMed 22413889Kan JY, Rungcharassaeng K, Bohsali K, Goodacre CJ, Lang BR. Clinical methods for evaluating implant framework fit. J Prosthet Dent. 1999 Jan;81(1):7-13. doi: 10.1016/s0022-3913(99)70229-5.
PubMed 9878969Ebadian B, Rismanchian M, Dastgheib B, Bajoghli F. Effect of different impression materials and techniques on the dimensional accuracy of implant definitive casts. Dent Res J (Isfahan). 2015 Mar-Apr;12(2):136-43.
PubMed 25878678
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Accuracy and Timing Parameter of Digital and Conventional Impression Techniques on Fully Edentulous Jaws: an in Vivo Study
- ClinicalTrials.gov ID
- NCT03992300
- Acronym / sponsor ID
- REST-ECT-2017-03
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To determine if adjustment of full-arch zirconia frameworks processed on a model obtained with an intraoral scanner and an auxiliary device is not inferior to that of identical frameworks obtained from an elastomeric impression.
Materials and methods: Eight consecutive patients ready for a full-arch rehabilitation on already osseointegrated implants were selected. Two sets of impressions were taken, one open tray with polyether and splinted impression copings and a second one with an intraoral scanner. A verification plaster jig was used for the elastomeric impression and a prefabricated auxiliary device was used to adjust the optical intraoral impressions. Two full-zirconia frameworks with the same design were processed and tested on the patient by two independent calibrated operators. Accuracy of both frameworks was measured by calibrated blinded operators, who determined tactile adjustment, Sheffield test, radiographic adjustment, and screwing torque. Overall perception of adjustment was used to determine the better framework to be delivered to the patient.
Hº: Frameworks obtained from an impression taken with an intraoral scanner are not inferior in accuracy to those obtained from a conventional elastomeric impression
Detailed description
Eight consecutive patients ready for a full-arch rehabilitation on previously osseointegrated implants, and who had received an immediately loaded prosthesis, were selected. All implants had multiunit abutments placed on top. Cases from 4 to 6 implants were accepted, either upper or lower arches. Three sets of impressions were taken to each patient:
Conventional impression:
Open tray impression copings were screwed on top of all implants in the arch using a torque wrench set at 10 N/cm. Impression copings were splinted by means of Triad Gel clear resin, with an at least 3mm diameter in the resin connectors. Once the resin was photo-polymerized a cut was done in the centre of each connection with a 0.3 mm bur, to eliminate possible stress in the structure, and then it was splinted again with a drop of Triad Gel in each cut. A polyether impression was taken by means of a perforated plastic tray, and a master model was fabricated following the manufacturer's instructions. A plaster verification jig was fabricated on the model. After one week the patient came to the dental clinic where vertical dimension of occlusion was determined and the plaster key was screwed in the patient mouth to check passivity. In case the key had been fractured, a new impression would have been taken, and if not, final prosthesis could be processed.
Optical impression:
An impression of the antagonist and an impression of the edentulous arch with the healing abutments in place were taken by means of an optical scanner following the manufacturers protocol. The position of the implants was marked in the working standard tessellation language (STL) model, and the software cut a circle on top of those areas. The files were copied, and two datasets were obtained.
Scan-bodies were placed on top of each multiunit abutment, the first STL dataset was open and a second impression was taken, so that the scan-bodies were positioned on the working file.
Scan-bodies were then removed from the patient mouth, and temporary copings were placed on top of each multiunit abutment. A MedicalFit device was selected, and holes were drilled in the position of the implants until it fitted on top of all the cylinders. Cylinders were then splinted to MedicalFit device by means of Triad Gel clear. The device was then removed from the patient mouth and scan implant replicas were placed at the bottom of the metal cylinders. Finally, the device with the scan implant replicas was scanned with an intraoral optical scanner.
The following set of pictures were taken: Rest position, maximum smile (with the scan bodies placed in the mouth), front with retractors (with the scan bodies), and 45º with retractors (also with the scan bodies in place).
All pictures and STL datasets were sent to the dental technician to produce a temporary structure. The STL dataset from the scanning of Medicalfit device used was adjusted to the original STL dataset of the device in the library, and then superimposed to the dataset of the scan-bodies received from us, to allow repositioning of the scan-bodies and to correct possible discrepancies during the intraoral scanning process.
A temporary polymethylmethacrylate (PMMA) framework was delivered by the dental lab and tried in the patient mouth. Corrections were done to adjust occlusion, gingival contour and esthetic parameters where needed. Once esthetic parameters and occlusal scheme were considered correct, a new intraoral scanning was taken with the temporary framework in place. In case changes were done in the gingival contour, scanning of the gingival aspect of the PMMA framework was also done. The PMMA temporary was then left in the patient mouth.
Three pictures were taken with the PMMA framework placed in the mouth: Front full face at rest, front full-face smiling, front full face with separators and full face smiling at 45º.
Clinical adjustment assessment:
After one week two sets of the final prosthesis in full-zirconia were sent from the dental lab, one processed with conventional models and the second fully digital. Both sets were tested in the patient mouth by two calibrated blinded independent operators.
Misfit should be ideally measured in terms smaller than 10 microns, but clinical adjustment is difficult to assess using conventional or quantitative methods. In this research adjustment was assessed following four criteria: passivity in the insertion of the screws, tactile sensation, radiographs and screwing torque:
- A Visual Analogue Scale (VAS) was used to assess the perception of passivity in the insertion of the prosthodontic screws. A ten centimeters line will be shown to the observer. One side of the line represents "perfect passivity", and the other "no passive at all". The observer will mark his passivity perception on the line between the two endpoints. The distance between "no passivity at all" and the mark will defines the passivity perception.
- Examination of the marginal fit with an exploratory probe (#23/3 explorer) under 3,8x magnification. Three possible scores were possible: 0 (no gap perceived when probing), 1 (perception of the gap without entering it) and 2 (the tip of the explorer clearly entered the gap).
- Periapical radiographs were taken with a positioning system to evaluate possible gaps. Five possible scores were possible from 1 to 5, being 1 no gap and increasing 0.15 mm each score until reaching 0.60 mm in score 5.
- Digital photographs were taken with a 105 mm macro lens. The pictures were calibrated with the known height of the framework and the gap was measured. Four possible scores were possible, being 1 no gap and increasing 0.25 mm each score until reaching 0.75 mm in score 5.
- Screwing torque on each abutment was measured with the app software from Ichiropro motor (BienAir, Bienne, Switzerland). All screws were hand screwed and then all but the most distal right were unscrewed. Torque was set at 15 N/cm and speed at 5 rpm. The most right distal screw was tightened first, and then the rest of the screws were tightened starting at the most mesial left, following to the most distal left, and from that to the next neighbor implant until all screws were tightened. The torque-time signature was studied in every screw to determine if the torque started to grow just at the end of the tightening or throughout the process. Three scores were possible: 1 for linear value with a fast increase at end of the tightening, 2 for soft continuous growth with a steeper increase at the end, 3 for steep increase at the beginning of tightening.
Once the assessment of the two frameworks was completed, the framework with better adjustment will be placed in the patient, after assessing the presence of correct occlusion, phonetics and esthetic parameters. The second set will be packed and delivered to the patient as a possible replacement in case of problems in the future.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two frameworks with the same design obtained from two different models (intraoral scanning and conventional impression) are processed and tested in every patient
| Arm | Type | Receives |
|---|---|---|
| Intraoral scanning | Experimental | Device: Clinical adjustmentAn intraoral scanning is taken. An auxiliary device is used to achieve better accuracy. A zirconia framework is produced |
| Conventional scanning | Active comparator | Device: Clinical adjustmentA conventional elastomeric impression is taken and a zirconia framework is produced |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ·Patients with four or more implants already osseo-integrated ready to rehabilitate with a full-arch implant-supported framework of 10 or more units. ·Upper or lower jaw.
Key exclusion criteria (6 listed)
- Implants not suitable for multiunit abutments.
- More than six implants.
- Peri-implantitis present in any implant.
- Need of a removable prosthesis.
- Patients unable to understand the purpose of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical adjustmentAccuracy of the framework is checked in the patient mouth by tactile perception, screwing torque, Sheffield test and radiography. | Device | Conventional scanning, Intraoral scanning |
Primary outcome
Accuracy of the framework
Time frame: one day
Overall perception of adjustment of the two frameworks
4 secondary outcomes
Perception of the passivity
Time frame: 1 day
Optical adjustment
Time frame: 1 day
Radiographic adjustment
Time frame: 1 day
Screwing torque
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 18922257Lee H, So JS, Hochstedler JL, Ercoli C. The accuracy of implant impressions: a systematic review. J Prosthet Dent. 2008 Oct;100(4):285-91. doi: 10.1016/S0022-3913(08)60208-5.
- Background: PubMed 11887597al-Turki LE, Chai J, Lautenschlager EP, Hutten MC. Changes in prosthetic screw stability because of misfit of implant-supported prostheses. Int J Prosthodont. 2002 Jan-Feb;15(1):38-42.
- Background: PubMed 9274082Jansen VK, Conrads G, Richter EJ. Microbial leakage and marginal fit of the implant-abutment interface. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):527-40.
- Background: PubMed 8595110Millington ND, Leung T. Inaccurate fit of implant superstructures. Part 1: Stresses generated on the superstructure relative to the size of fit discrepancy. Int J Prosthodont. 1995 Nov-Dec;8(6):511-6.
- Background: PubMed 11450418Sahin S, Cehreli MC. The significance of passive framework fit in implant prosthodontics: current status. Implant Dent. 2001;10(2):85-92. doi: 10.1097/00008505-200104000-00003.
- Background: PubMed 20556249Abduo J, Bennani V, Waddell N, Lyons K, Swain M. Assessing the fit of implant fixed prostheses: a critical review. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):506-15.
- Background: PubMed 28944373Katsoulis J, Takeichi T, Sol Gaviria A, Peter L, Katsoulis K. Misfit of implant prostheses and its impact on clinical outcomes. Definition, assessment and a systematic review of the literature. Eur J Oral Implantol. 2017;10 Suppl 1:121-138.
- Background: PubMed 8666454Assif D, Marshak B, Schmidt A. Accuracy of implant impression techniques. Int J Oral Maxillofac Implants. 1996 Mar-Apr;11(2):216-22.
- Background: PubMed 28720339Al-Meraikhi H, Yilmaz B, McGlumphy E, Brantley W, Johnston WM. In vitro fit of CAD-CAM complete arch screw-retained titanium and zirconia implant prostheses fabricated on 4 implants. J Prosthet Dent. 2018 Mar;119(3):409-416. doi: 10.1016/j.prosdent.2017.04.023. Epub 2017 Jul 15.
- Background: PubMed 1813395Jemt T. Failures and complications in 391 consecutively inserted fixed prostheses supported by Branemark implants in edentulous jaws: a study of treatment from the time of prosthesis placement to the first annual checkup. Int J Oral Maxillofac Implants. 1991 Fall;6(3):270-6.
- Background: PubMed 3904064Klineberg IJ, Murray GM. Design of superstructures for osseointegrated fixtures. Swed Dent J Suppl. 1985;28:63-9. No abstract available.
- Background: PubMed 24726587Gibbs SB, Versluis A, Tantbirojn D, Ahuja S. Comparison of polymerization shrinkage of pattern resins. J Prosthet Dent. 2014 Aug;112(2):293-8. doi: 10.1016/j.prosdent.2014.02.006. Epub 2014 Apr 14.
- Individual participant dataSharing planned: No. We plan to publish the data in a paper
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MIGUEL ROIG CAYON, MD DDS PHD study director
Unversitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical adjustment in people with Edentulous Jaw, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the framework (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03992300, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.