Edentulous MouthNCT04475913
Digital vs Analog Impression in Cases of All-on-4 - Prosthesis
A study testing DIG Axial, DIG Tilted and CIG Axial in people with Edentulous Mouth, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
Fifty six patients were randomly enrolled in the study. Participants were randomly stratified into two control groups and two test groups, from which conventional pick up and digital impressions were made respectively. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- DIG Axial, DIG Tilted and CIG Axial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2018to 20 Aug 2020
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely edentulous patients with age range from 50-65 years.
- physically and psychologically eligible participants for implants placement.
- adequate bone to receive 4 interforaminal implants.
Who cannot join
- participants were excluded if
- medical conditions that precludes implants placement
- smokers
- patients suffering from any parafunctional habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In a Post -Covid-19 World, What is the Clinical Influence of Digital vs Analog Impression in Cases of All-on-4 - Prosthesis ?
Fifty six patients were randomly enrolled in the study. Participants were randomly stratified into two control groups and two test groups, from which conventional pick up and digital impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial) received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted) received two anterior axial implants and two distal tilted implants.
All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis were evaluated at 6m,12m, and 24 months follow up period.
- Conditions
- Edentulous Mouth
- Being tested
- DIG Axial, DIG Tilted, CIG Axial, CIG Tilted
- Keywords
- impressions, analogue, digital, All-on-Four
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIG AxialOther
patients received 4 axial implants and digital impression
DIG TiltedOther
received two anterior axial implants and two distal tilted implants, and digital impression
CIG AxialOther
patients received 4 axial implants and conventional impression
CIG TiltedOther
received two anterior axial implants and two distal tilted implants, and conventional impression
| Study group | Role | What they receive |
|---|---|---|
| (CIG Axial) | Active comparator | received 4 axial implants and conventional impression Receives: Other: DIG Axial |
| (DIG Axial) | Experimental | received 4 axial implants and digital impression Receives: Other: DIG Tilted; Other: CIG Axial |
| CIG Tilted | Active comparator | received two anterior axial implants and two distal tilted implants, and conventional impression Receives: Other: DIG Tilted |
| (DIG Tilted) | Experimental | received two anterior axial implants and two distal tilted implants, and digital impression Receives: Other: DIG Axial; Other: CIG Tilted |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant loss
The implants were considered surviving if they were clinically stable and functioning without any mobility. Failure was defined removal of implants due to loss of integration, pain, implant mobility, paraesthesia, neuropathies or psychological reasons. Calculation of the estimated failure rate was performed by dividing the number of implant failures by the total exposure time of the implant. The total exposure time is the interval of time the implants could be followed for the entire observation time or up to failure of the implants that were lost during the follow-up period.
Measured: 24 months
Secondary outcomes (1)
crestal bone loss
Standardized periapical radiographs with long cone paralleling technique using film holders were used for the assessment of crestal bone loss. The loss of marginal bone relative to the implant shoulder at the mesial and distal of each implant was measured in mm and then the mean was calculated and statistically estimated. A digital intraoral imaging system was used (Digora phosphor plate reader, Soredex Tuusula, Finland). All the radiographs were scanned and then uploaded into the computer for assessing bone loss over time. The "ImageJ" software was used to take the measurements on the computer screen. Postoperative radiographs with the implants placed at the crest of the bone were compared with the 6,12 and 24 m radiographs.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start11 Jul 2018
- Primary completion11 Jul 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dina Elawady, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475913
- Sponsor's protocol ID
- 5
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In a Post -Covid-19 World, What is the Clinical Influence of Digital vs Analog Impression in Cases of All-on-4 - Prosthesis ?
- ClinicalTrials.gov ID
- NCT04475913
- Acronym / sponsor ID
- 5
- Conditions
- Edentulous Mouth
- Keywords
- impressions, analogue, digital, All-on-Four
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 11 Jul 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 17 Jul 2020 (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.
Fifty six patients were randomly enrolled in the study. Participants were randomly stratified into two control groups and two test groups, from which conventional pick up and digital impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial) received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted) received two anterior axial implants and two distal tilted implants.
All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis were evaluated at 6m,12m, and 24 months follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (CIG Axial) | Active comparator | Other: DIG Axialreceived 4 axial implants and conventional impression |
| (DIG Axial) | Experimental | Other: DIG Tilted, Other: CIG Axialreceived 4 axial implants and digital impression |
| CIG Tilted | Active comparator | Other: DIG Tiltedreceived two anterior axial implants and two distal tilted implants, and conventional impression |
| (DIG Tilted) | Experimental | Other: DIG Axial, Other: CIG Tiltedreceived two anterior axial implants and two distal tilted implants, and digital impression |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- completely edentulous patients with age range from 50-65 years.
- physically and psychologically eligible participants for implants placement.
- adequate bone to receive 4 interforaminal implants.
Key exclusion criteria (4 listed)
- participants were excluded if
- medical conditions that precludes implants placement
- smokers
- patients suffering from any parafunctional habits
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 |
|---|---|---|
| DIG Axialpatients received 4 axial implants and digital impression | Other | (CIG Axial), (DIG Tilted) |
| DIG Tiltedreceived two anterior axial implants and two distal tilted implants, and digital impression | Other | (DIG Axial), CIG Tilted |
| CIG Axialpatients received 4 axial implants and conventional impression | Other | (DIG Axial) |
| CIG Tiltedreceived two anterior axial implants and two distal tilted implants, and conventional impression | Other | (DIG Tilted) |
Primary outcome
implant loss
Time frame: 24 months
The implants were considered surviving if they were clinically stable and functioning without any mobility. Failure was defined removal of implants due to loss of integration, pain, implant mobility, paraesthesia, neuropathies or psychological reasons. Calculation of the estimated failure rate was performed by dividing the number of implant failures by the total exposure time of the implant. The total exposure time is the interval of time the implants could be followed for the entire observation time or up to failure of the implants that were lost during the follow-up period.
1 secondary outcome
crestal bone loss
Time frame: 24 months
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 1 Mar 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.
Dina Elawady principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIG Axial, DIG Tilted and CIG Axial in people with Edentulous Mouth, run by October University for Modern Sciences and Arts 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 3 inclusion and 4 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 1 Mar 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?
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?
implant loss (time frame: 24 months). 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 Mar 2021.