AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Turkey (Türkiye)

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 groups in NCT06400277
Study groupRoleWhat they receive
Irreversible HydrocolloidOtherFinal impression taken with irreversible hydrocolloid impression material and stock tray in single step.
Receives: Other: Edentulous maxilla final impression for complete denture
Zinc Oxide EugenolOtherFinal 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 OffOtherFinal 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 OnOtherFinal impression taken with intraoral scanner in artificial intelligence mode activated in single step.
Receives: Other: Edentulous maxilla final impression for complete denture
Intraoral Scanner - ModifiedOtherFinal 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.

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted6 May 2024
  2. Study start30 Jul 2022
  3. Primary completion30 Dec 2023
  4. Study completion27 Mar 2024

Resources

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)
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 32331785
  • Lo 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 31153614
  • Chebib 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 30580982
  • Kahya 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in