Missing TeethNCT04908618
The Accuracy of Conventional Versus Digital Implant Impression Techniques
A study testing digital impression for normal abutment, open tray impression and closed tray impression in people with Missing Teeth, run by Mohamed Mahmoud Dohiem at 1 site in Egypt.
Trial summary
Intraoral oral scanning significantly improves scanning accuracy compared to digitized conventional impression techniques. The digitized closed tray impression technique showed significantly more accurate results than the digitized open-tray impression technique in partially edentulous patients. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- digital impression for normal abutment, open tray impression and closed tray impression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2021to 22 May 2021
- 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 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Partial edentulous patients
- Sufficient bone volume to insert implants
- Age ranging from 30-50.
- Good oral hygiene.
- Intact hard and soft tissues, including treated teeth decay and healed teeth extraction socket
Who cannot join
- • Completely edentulous patients
- Patients with Bruxism or clinching
- need for bone augmentation,
- uncompensated diabetes mellitus,
- immunocompromised status, radio- and/or chemotherapy
- previous treatment with oral and/or intravenous aminobisphosphonates.
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- Undergoing orthodontic treatment;
- Patients with metal crowns and any other metal materials on teeth
- Patients with soft tissue lesions and postoperative scars on the palate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Mahmoud Dohiem
Cairo
mohamed mahmoud, lecturer, 01002411965, mdohiem@zu.edu.eg
About this study
Official title: Comparing the Accuracy of Intraoral Scanning of Ready Made Abutments Versus Intraoral Scan Bodies, Digitized Conventional Open and Closed Tray Implant Impression Techniques. A Controlled Clinical Trial
Intraoral oral scanning significantly improves scanning accuracy compared to digitized conventional impression techniques. The digitized closed tray impression technique showed significantly more accurate results than the digitized open-tray impression technique in partially edentulous patients.
Read the detailed description
The study was a controlled clinical trial using cone-beam computed tomography (CBCT) imaging and flapless surgical technique to place implants. Cone-beam Computed Topography of the patients was taken by x-ray machine to create a DICOM file of the patient. Intraoral scanning to create STL Files of the patient arches. Each patient had undergone four impression techniques: Conventional impression I; Closed tray impression technique, Conventional impression II; Splinted Open tray impression technique, Digital impression I; intraoral scanning of readymade abutments and Digital impression II; intraoral scanning using scan bodies. To digitize the Conventional impressions I and II, the readymade abutment was screwed on the analogs of the resultant stone casts, followed by digital scanning. Using the scan body, the exact implant position was determined and the implants were added using a digital library. The custom abutment was fabricated on the implant replica with the same readymade abutment measurement. Using the inspection software, a custom abutment was superimposed on each readymade abutment in all the readymade abutment scanning data with the best-fit algorithm. Then the custom abutment was saved as a new STL file for comparison. The digital impression I was set as a reference in all the coming comparisons. The comparison was done from different data acquisition techniques by using inspection software between Digital impression I, Digital impression II; and finally, with the digitized STL of the Conventional impressions I and II.
- Conditions
- Missing Teeth
- Being tested
- digital impression for normal abutment, open tray impression, closed tray impression
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital impression for normal abutmentOther
Accuracy of scan body impression
open tray impressionOther
Accuracy of open tray impression
closed tray impressionOther
Accuracy of closed tray impression
| Study group | Role | What they receive |
|---|---|---|
| digital impression with normal abutment for dental implant | Active comparator | digital impression using a ready-made abutment for dental implant Receives: Other: digital impression for normal abutment; Other: open tray impression; Other: closed tray impression |
| digital impression with scan abutment for dental implant | Experimental | digital impression with scan body abutment for dental implant Receives: Other: digital impression for normal abutment; Other: open tray impression; Other: closed tray impression |
| open tray conventional dental implant impression | Experimental | Digitized open tray dental implant impression Receives: Other: digital impression for normal abutment; Other: open tray impression; Other: closed tray impression |
| closed tray impression for dental implant | Experimental | Digitized closed tray dental implant impression Receives: Other: digital impression for normal abutment; Other: open tray impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
total deviation between digital impression and conventional impression
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 posted1 Jun 2021
- Study start20 May 2021
- Primary completion21 May 2021
- Study completion22 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- control clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Mahmoud Dohiem
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mohamed Mahmoud Dohiem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908618
- Sponsor's protocol ID
- 256413854
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Accuracy of Intraoral Scanning of Ready Made Abutments Versus Intraoral Scan Bodies, Digitized Conventional Open and Closed Tray Implant Impression Techniques. A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04908618
- Acronym / sponsor ID
- 256413854
- Conditions
- Missing Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Mohamed Mahmoud DohiemOther government
- Study start
- 20 May 2021 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 22 May 2021 (estimated)
- First posted
- 1 Jun 2021 (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.
Intraoral oral scanning significantly improves scanning accuracy compared to digitized conventional impression techniques. The digitized closed tray impression technique showed significantly more accurate results than the digitized open-tray impression technique in partially edentulous patients.
Detailed description
The study was a controlled clinical trial using cone-beam computed tomography (CBCT) imaging and flapless surgical technique to place implants. Cone-beam Computed Topography of the patients was taken by x-ray machine to create a DICOM file of the patient. Intraoral scanning to create STL Files of the patient arches. Each patient had undergone four impression techniques: Conventional impression I; Closed tray impression technique, Conventional impression II; Splinted Open tray impression technique, Digital impression I; intraoral scanning of readymade abutments and Digital impression II; intraoral scanning using scan bodies. To digitize the Conventional impressions I and II, the readymade abutment was screwed on the analogs of the resultant stone casts, followed by digital scanning. Using the scan body, the exact implant position was determined and the implants were added using a digital library. The custom abutment was fabricated on the implant replica with the same readymade abutment measurement. Using the inspection software, a custom abutment was superimposed on each readymade abutment in all the readymade abutment scanning data with the best-fit algorithm. Then the custom abutment was saved as a new STL file for comparison. The digital impression I was set as a reference in all the coming comparisons. The comparison was done from different data acquisition techniques by using inspection software between Digital impression I, Digital impression II; and finally, with the digitized STL of the Conventional impressions I and II.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- control clinical trial
| Arm | Type | Receives |
|---|---|---|
| digital impression with normal abutment for dental implant | Active comparator | Other: digital impression for normal abutment, Other: open tray impression, Other: closed tray impressiondigital impression using a ready-made abutment for dental implant |
| digital impression with scan abutment for dental implant | Experimental | Other: digital impression for normal abutment, Other: open tray impression, Other: closed tray impressiondigital impression with scan body abutment for dental implant |
| open tray conventional dental implant impression | Experimental | Other: digital impression for normal abutment, Other: open tray impression, Other: closed tray impressionDigitized open tray dental implant impression |
| closed tray impression for dental implant | Experimental | Other: digital impression for normal abutment, Other: open tray impressionDigitized closed tray dental implant impression |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Partial edentulous patients
Key exclusion criteria (9 listed)
- • Completely edentulous patients
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 |
|---|---|---|
| digital impression for normal abutmentAccuracy of scan body impression | Other | closed tray impression for dental implant, digital impression with normal abutment for dental implant, digital impression with scan abutment for dental implant, open tray conventional dental implant impression |
| open tray impressionAccuracy of open tray impression | Other | closed tray impression for dental implant, digital impression with normal abutment for dental implant, digital impression with scan abutment for dental implant, open tray conventional dental implant impression |
| closed tray impressionAccuracy of closed tray impression | Other | digital impression with normal abutment for dental implant, digital impression with scan abutment for dental implant, open tray conventional dental implant impression |
Primary outcome
total deviation between digital impression and conventional impression
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital impression for normal abutment, open tray impression and closed tray impression in people with Missing Teeth, run by Mohamed Mahmoud Dohiem at 1 site in Egypt.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Jun 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed M DOHIEM, lecturer (00201002411965, mdohiem@zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total deviation between digital impression and conventional impression (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2021.