Edentulous JawNCT06400277
In-Vivo Comparison of Different Impression Methods in Complete Edentulous Upper Jaw
A study testing Edentulous maxilla final impression for complete denture in people with Edentulous Jaw, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to compare the impressions taken with different impression techniques for the production of tissue-supported complete dentures from individuals with complete edentulous upper jaws. 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?
- Edentulous maxilla final impression for complete denture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2022to 27 Mar 2024
- 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
- Volunteers who had been using maxillary complete denture for at least 3 months
- Volunteers were clinically evaluated for healthy oral mucosa
Who cannot join
- Volunteers who had general health problems
- Volunteers who had of tissue hyperplasia, labile alveolar crest, allergic reaction to the prosthesis, percussion or mucosal irritation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry
Ankara, Altındağ
About this study
In this study, it was aimed to compare the impressions taken with different impression techniques for the production of tissue-supported complete dentures from individuals with complete edentulous upper jaws. For this purpose, 15 individuals with complete edentulism in the upper jaw were asked to participate in the study. In addition to agreeing to participate in the study after reading the consent form, these individuals should have been using tissue-supported complete dentures in the upper jaw for at least 3 months. They should also have healthy mucosa without local factors such as tissue hyperplasia, atrophic crests, allergic reaction, epulis fissuratum. A total of five final impressions will then be taken from these individuals in two sessions. Two of these impressions will be obtained with the traditional method and three with the digital method. The traditional impression group will include one-step (ALG) and two-step (ZOE) impression techniques. The digital impression group will include the digital impression taken when the artificial intelligence is deactivated (A.I OFF), the digital impression taken when the artificial intelligence is activated (A.I ON) and the modified technique (MOD). In the first appointment, the first impressions will be taken for the traditional and digital groups. Intraoral exclusion and isolation will be provided before the digital first impression. With the A.I mode of the intraoral scanner (TRIOS4; 3Shape A/S, Copenhagen, Denmark) deactivated, scanning will be performed in accordance with the scanning protocol recommended by the company. A metal stock tray suitable for the dental arch will then be selected for the preliminary impression of the traditional impression group. The impression will be taken in one step with irreversible hydrocolloid impression material. The impression will be digitized with the same intraoral scanner within the first 10 minutes after impression taking. Both impressions will be digitally transferred to the dental laboratory as stl data. Using computer aided design (CAD) software (Exocad DentalCAD 2.4 Plovdiv), an individual tray will be designed for the ZOE impression in the traditional group and a pedestal for the MOD impression in the digital impression group. The designs will be transferred to the computer aided manufacturing (CAM) unit and produced with a 3D printer using dental resin. The occlusal-rim (OR) will be prepared by adding wax on the base.
In the second appointment, the cheek and lips will be excluded in the same way before scanning. For A.I OFF and A.I ON, recordings will be taken when the artificial intelligence is deactivated and activated, respectively. Then, occlusal vertical dimension, intermaxillary relationship and aesthetic parameters will be determined with OR before scanning for the MOD group. Reference areas will be created on the buccal and palatinal walls to facilitate scanning of the OR. To avoid retention problems during scanning, a silicone-based impression material with a fluid consistency will be applied to the tissue surface of the OR and placed in the mouth. Scanning will be performed according to the protocol proposed by Lo Russo et al. For the traditional impression group, the ALG impression will be taken with a metal stock tray using irreversible hydrocolloid impression material in a single step. The impression will be digitized with an intraoral scanner within ten minutes of completion. Then, the edges of the individual tray for ZOE will be shaped with impression compound to ensure peripheral closure. The impression will be completed with zinc-oxide eugenol impression material. The impression will be digitized. These measurements will then be compared using a reverse-engineering program (Geomagic design X version 2016.1.0, 3D Systems Inc. Rock Hill, SC). Before the comparison, in the same program, the parts to be evaluated on the ZOE in the conventional group and A.I OFF in the digital group will be divided into regions. These areas will be divided into four sections as right and left vestibular region, postdam area, hard palate region, except for the A.I OFF-MOD comparison group. In the A.I OFF-MOD comparison group, it will include the right and left initial areas, including the areas where scanning starts in the second scan of the MOD method. In addition, all measurements will be compared in terms of the whole surface and all measurement boundaries including the whole measurement surface as one. The comparison groups are ZOE-ALG, ZOE-A.I OFF, A.I OFF-A.I ON, A.I OFF-MOD. The measurements in the comparison groups will be overlapped first with the initial alignment and then with the best fit alignment algorithm. All sections will be evaluated individually with the "3D compare" feature and the amount of deviation in the areas to be evaluated will be determined.
- Conditions
- Edentulous Jaw
- Being tested
- Edentulous maxilla final impression for complete denture
- Keywords
- Edentulous Jaw, Digital Impression, Physical Impression
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edentulous maxilla final impression for complete dentureOther
Final impressions of edentulous maxilla separated in two groups. In physical impression group stock and individual trays and physical impression materials used.
| Study group | Role | What they receive |
|---|---|---|
| Irreversible Hydrocolloid | Other | Final impression taken with irreversible hydrocolloid impression material and stock tray in single step. Receives: Other: Edentulous maxilla final impression for complete denture |
| Zinc Oxide Eugenol | Other | Final impression taken with zinc oxide eugenol impression material and individual tray in two steps. Receives: Other: Edentulous maxilla final impression for complete denture |
| Intraoral Scanner - Artificial Intelligence Off | Other | Final impression taken with intraoral scanner in artificial intelligence mode deactivated in single step. Receives: Other: Edentulous maxilla final impression for complete denture |
| Intraoral Scanner - Artificial Intelligence On | Other | Final impression taken with intraoral scanner in artificial intelligence mode activated in single step. Receives: Other: Edentulous maxilla final impression for complete denture |
| Intraoral Scanner - Modified | Other | Final impression taken with intraoral scanner in two steps using occlusal rim. Receives: Other: Edentulous maxilla final impression for complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three Dimensional Difference Between Irreversible Hydrocolloid and Zinc Oxide Eugenol Impressions
Evaluation of the three-dimensional difference between two impressions using a reverse-engineering program and quantification of the deviation
Measured: Through study completion, an average of 6 months
Three Dimensional Difference Between Zinc Oxide Eugenol and Intraoral Scanner AI Off Impressions
Evaluation of the three-dimensional difference between two impressions using a reverse-engineering program and quantification of the deviation
Measured: Through study completion, an average of 6 months
Three Dimensional Difference Between Intraoral Scanner AI Off and AI On Impressions
Evaluation of the three-dimensional difference between two impressions using a reverse-engineering program and quantification of the deviation
Measured: Through study completion, an average of 6 months
Three Dimensional Difference Between Intraoral Scanner AI Off and Modified Impressions
Evaluation of the three-dimensional difference between two impressions using a reverse-engineering program and quantification of the deviation
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start30 Jul 2022
- Primary completion30 Dec 2023
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Kahya Karaca, Hacettepe University
- Investigators
- Sinem Kahya Karaca, Principal investigator, Hacettepe UniversityKıvanç Akça, Prof. Dr., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400277
- Sponsor's protocol ID
- KA-22026
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lo Russo L, Salamini A, Troiano G, Guida L. Digital dentures: A protocol based on intraoral scans. J Prosthet Dent. 2021 Apr;125(4):597-602. doi: 10.1016/j.prosdent.2020.02.006. Epub 2020 Apr 21.
PubMed 32331785Lo Russo L, Caradonna G, Troiano G, Salamini A, Guida L, Ciavarella D. Three-dimensional differences between intraoral scans and conventional impressions of edentulous jaws: A clinical study. J Prosthet Dent. 2020 Feb;123(2):264-268. doi: 10.1016/j.prosdent.2019.04.004. Epub 2019 May 29.
PubMed 31153614Chebib N, Kalberer N, Srinivasan M, Maniewicz S, Perneger T, Muller F. Edentulous jaw impression techniques: An in vivo comparison of trueness. J Prosthet Dent. 2019 Apr;121(4):623-630. doi: 10.1016/j.prosdent.2018.08.016. Epub 2018 Dec 21.
PubMed 30580982Kahya Karaca S, Akca K. Comparison of conventional and digital impression approaches for edentulous maxilla: clinical study. BMC Oral Health. 2024 Nov 14;24(1):1378. doi: 10.1186/s12903-024-05151-3.
PubMed 39543593
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Comparison of Different Impression Methods in Complete Edentulous Upper Jaw
- ClinicalTrials.gov ID
- NCT06400277
- Acronym / sponsor ID
- KA-22026
- Conditions
- Edentulous Jaw
- Keywords
- Edentulous Jaw, Digital Impression, Physical Impression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 6 May 2024 (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.
In this study, it was aimed to compare the impressions taken with different impression techniques for the production of tissue-supported complete dentures from individuals with complete edentulous upper jaws. For this purpose, 15 individuals with complete edentulism in the upper jaw were asked to participate in the study. In addition to agreeing to participate in the study after reading the consent form, these individuals should have been using tissue-supported complete dentures in the upper jaw for at least 3 months. They should also have healthy mucosa without local factors such as tissue hyperplasia, atrophic crests, allergic reaction, epulis fissuratum. A total of five final impressions will then be taken from these individuals in two sessions. Two of these impressions will be obtained with the traditional method and three with the digital method. The traditional impression group will include one-step (ALG) and two-step (ZOE) impression techniques. The digital impression group will include the digital impression taken when the artificial intelligence is deactivated (A.I OFF), the digital impression taken when the artificial intelligence is activated (A.I ON) and the modified technique (MOD). In the first appointment, the first impressions will be taken for the traditional and digital groups. Intraoral exclusion and isolation will be provided before the digital first impression. With the A.I mode of the intraoral scanner (TRIOS4; 3Shape A/S, Copenhagen, Denmark) deactivated, scanning will be performed in accordance with the scanning protocol recommended by the company. A metal stock tray suitable for the dental arch will then be selected for the preliminary impression of the traditional impression group. The impression will be taken in one step with irreversible hydrocolloid impression material. The impression will be digitized with the same intraoral scanner within the first 10 minutes after impression taking. Both impressions will be digitally transferred to the dental laboratory as stl data. Using computer aided design (CAD) software (Exocad DentalCAD 2.4 Plovdiv), an individual tray will be designed for the ZOE impression in the traditional group and a pedestal for the MOD impression in the digital impression group. The designs will be transferred to the computer aided manufacturing (CAM) unit and produced with a 3D printer using dental resin. The occlusal-rim (OR) will be prepared by adding wax on the base.
In the second appointment, the cheek and lips will be excluded in the same way before scanning. For A.I OFF and A.I ON, recordings will be taken when the artificial intelligence is deactivated and activated, respectively. Then, occlusal vertical dimension, intermaxillary relationship and aesthetic parameters will be determined with OR before scanning for the MOD group. Reference areas will be created on the buccal and palatinal walls to facilitate scanning of the OR. To avoid retention problems during scanning, a silicone-based impression material with a fluid consistency will be applied to the tissue surface of the OR and placed in the mouth. Scanning will be performed according to the protocol proposed by Lo Russo et al. For the traditional impression group, the ALG impression will be taken with a metal stock tray using irreversible hydrocolloid impression material in a single step. The impression will be digitized with an intraoral scanner within ten minutes of completion. Then, the edges of the individual tray for ZOE will be shaped with impression compound to ensure peripheral closure. The impression will be completed with zinc-oxide eugenol impression material. The impression will be digitized. These measurements will then be compared using a reverse-engineering program (Geomagic design X version 2016.1.0, 3D Systems Inc. Rock Hill, SC). Before the comparison, in the same program, the parts to be evaluated on the ZOE in the conventional group and A.I OFF in the digital group will be divided into regions. These areas will be divided into four sections as right and left vestibular region, postdam area, hard palate region, except for the A.I OFF-MOD comparison group. In the A.I OFF-MOD comparison group, it will include the right and left initial areas, including the areas where scanning starts in the second scan of the MOD method. In addition, all measurements will be compared in terms of the whole surface and all measurement boundaries including the whole measurement surface as one. The comparison groups are ZOE-ALG, ZOE-A.I OFF, A.I OFF-A.I ON, A.I OFF-MOD. The measurements in the comparison groups will be overlapped first with the initial alignment and then with the best fit alignment algorithm. All sections will be evaluated individually with the "3D compare" feature and the amount of deviation in the areas to be evaluated will be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Irreversible Hydrocolloid | Other | Other: Edentulous maxilla final impression for complete dentureFinal impression taken with irreversible hydrocolloid impression material and stock tray in single step. |
| Zinc Oxide Eugenol | Other | Other: Edentulous maxilla final impression for complete dentureFinal impression taken with zinc oxide eugenol impression material and individual tray in two steps. |
| Intraoral Scanner - Artificial Intelligence Off | Other | Other: Edentulous maxilla final impression for complete dentureFinal impression taken with intraoral scanner in artificial intelligence mode deactivated in single step. |
| Intraoral Scanner - Artificial Intelligence On | Other | Other: Edentulous maxilla final impression for complete dentureFinal impression taken with intraoral scanner in artificial intelligence mode activated in single step. |
| Intraoral Scanner - Modified | Other | Other: Edentulous maxilla final impression for complete dentureFinal impression taken with intraoral scanner in two steps using occlusal rim. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteers who had been using maxillary complete denture for at least 3 months
- Volunteers were clinically evaluated for healthy oral mucosa
Key exclusion criteria (2 listed)
- Volunteers who had general health problems
- Volunteers who had of tissue hyperplasia, labile alveolar crest, allergic reaction to the prosthesis, percussion or mucosal irritation
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 |
|---|---|---|
| Edentulous maxilla final impression for complete dentureFinal impressions of edentulous maxilla separated in two groups. In physical impression group stock and individual trays and physical impression materials used. | Other | Intraoral Scanner - Artificial Intelligence Off, Intraoral Scanner - Artificial Intelligence On, Intraoral Scanner - Modified, Irreversible Hydrocolloid, Zinc Oxide Eugenol |
Primary outcome
Three Dimensional Difference Between Irreversible Hydrocolloid and Zinc Oxide Eugenol Impressions
Time frame: Through study completion, an average of 6 months
Evaluation of the three-dimensional difference between two impressions using a reverse-engineering program and quantification of the deviation
Three Dimensional Difference Between Zinc Oxide Eugenol and Intraoral Scanner AI Off Impressions
Time frame: Through study completion, an average of 6 months
Evaluation of the three-dimensional difference between two impressions using a reverse-engineering program and quantification of the deviation
Three Dimensional Difference Between Intraoral Scanner AI Off and AI On Impressions
Time frame: Through study completion, an average of 6 months
Evaluation of the three-dimensional difference between two impressions using a reverse-engineering program and quantification of the deviation
Three Dimensional Difference Between Intraoral Scanner AI Off and Modified Impressions
Time frame: Through study completion, an average of 6 months
Evaluation of the three-dimensional difference between two impressions using a reverse-engineering program and quantification of the deviation
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 6 May 2024.
- Background: PubMed 32331785Lo Russo L, Salamini A, Troiano G, Guida L. Digital dentures: A protocol based on intraoral scans. J Prosthet Dent. 2021 Apr;125(4):597-602. doi: 10.1016/j.prosdent.2020.02.006. Epub 2020 Apr 21.
- Background: PubMed 31153614Lo Russo L, Caradonna G, Troiano G, Salamini A, Guida L, Ciavarella D. Three-dimensional differences between intraoral scans and conventional impressions of edentulous jaws: A clinical study. J Prosthet Dent. 2020 Feb;123(2):264-268. doi: 10.1016/j.prosdent.2019.04.004. Epub 2019 May 29.
- Background: PubMed 30580982Chebib N, Kalberer N, Srinivasan M, Maniewicz S, Perneger T, Muller F. Edentulous jaw impression techniques: An in vivo comparison of trueness. J Prosthet Dent. 2019 Apr;121(4):623-630. doi: 10.1016/j.prosdent.2018.08.016. Epub 2018 Dec 21.
- Derived from this study: PubMed 39543593Kahya Karaca S, Akca K. Comparison of conventional and digital impression approaches for edentulous maxilla: clinical study. BMC Oral Health. 2024 Nov 14;24(1):1378. doi: 10.1186/s12903-024-05151-3.
- Individual participant dataSharing planned: No
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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.
Sinem Kahya Karaca principal investigator
Hacettepe University
Kıvanç Akça, Prof. Dr. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edentulous maxilla final impression for complete denture in people with Edentulous Jaw, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 6 May 2024. 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 Turkey (Türkiye). 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?
Three Dimensional Difference Between Irreversible Hydrocolloid and Zinc Oxide Eugenol Impressions (time frame: Through study completion, an average of 6 months). The study lists 4 primary outcomes in all. 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 NCT06400277, which also lists 4 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 6 May 2024.