Partial Edentulism Class 1NCT05912725
Conventional Impressions Versus Digital Impression Techniques for Implant Supported Screw Retained Prosthesis
A study testing Implant placement in people with Partial Edentulism Class 1, run by Tanta University at 1 site in Egypt.
Trial summary
The purpose was to evaluate the accuracy of traditional and digital implant level impression procedures by using three-dimensional superimposition analysis , and evaluate the passive fit of screw- retained implant supported restorations fabricated using conventional and digital impression techniques in bilateral… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism Class 1
- What is being tested?
- Implant placement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2020to 14 Dec 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants have sufficient bone length and width for implant insertion.
- General health of the patients was evaluated by taking a full medical history to ensure that these patients were free from any systemic conditions that would have impaired implant osseointegration
- Good oral hygiene
- Sufficient inter-arch spaces
- The opposing arch was almost dentulous, and any missing teeth were restored using a fixed partial denture.
Who cannot join
- parafunctional habits
- Heavy smoking
- Those patients with systemic diseases that may influence soft or hard tissue healing.
- Patients with a history of radiation therapy in the head and neck region.
- Patients with a history of radiation therapy in the head and neck region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Accuracy of Conventional and Digital Implant Impression Techniques in Bilateral Distal Extension Cases
The purpose was to evaluate the accuracy of traditional and digital implant level impression procedures by using three-dimensional superimposition analysis , and evaluate the passive fit of screw- retained implant supported restorations fabricated using conventional and digital impression techniques in bilateral distal extension cases (class I kennedy classification)
Read the detailed description
Eight patients who had missing all mandibular posterior teeth except first premolars were included in this study. In each patient, 4 implants were placed, 2 in each side to support 3 units screw retained zirconia restorations. Three months after implant placement, each patient underwent two implant level impression techniques (n=8) for each technique: Conventional implant impressions CII (pick-up, splinted transfers), and digital implant impressions DII were captured with TRIOS 3 Shape intraoral optical scanner. In this study, digital impression was considered as a reference data.
- Conditions
- Partial Edentulism Class 1
- Being tested
- Implant placement
- Keywords
- Digital impression, implant impression, impression accuracy, Digital work flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placementProcedure or surgery
4 implants were placed , 2 implants in each side of the patient mouth opposite lower second premolar and second molar
4 implants were placed , 2 implants in each side of the patient mouth opposite lower second premolar and second molar
| Study group | Role | What they receive |
|---|---|---|
| Accuracy of Implant impression techniques | Experimental | Active comparative : digital implant impression Participants underwent intra-oral scanning digital impression
Experimental : conventional implant impression Participants underwent conventional impressions And right side of pt mouth received screw retained prosthesis constructed from conventional impression left side received screws retained prosthesis constructed from digital impression Receives: Procedure: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of digital and conventional implant impression techniques in partially edentulous patient
GOM Inspect 2016, Gom GmbH,) that was used to superimpose the Standard tessellation language (STL) datasets of conventional open tray impression technique onto the STL file of the reference (digital implant impression technique) to assess the accuracy and calculate the three-dimensional deviations of scan bodies in color- coding map in micrometers (µm)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start30 Apr 2020
- Primary completion28 Dec 2021
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Edentulism Class 1Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa elashry, Tanta University
- Investigators
- Wafaa Y El ashry, MSc, Principal investigator, Tanta university ,Faculty of Dentistry, Prosthodontics departmentWafaa Y El ashry, Principal investigator, Tanta university, Faculty of Dentistry, Prosthodontics departmentWafaa Y El ashry, MSc, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912725
- Sponsor's protocol ID
- RP-9-20-1
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elashry WY, Elsheikh MM, Elsheikh AM. Evaluation of the accuracy of conventional and digital implant impression techniques in bilateral distal extension cases: a randomized clinical trial. BMC Oral Health. 2024 Jul 5;24(1):764. doi: 10.1186/s12903-024-04495-0.
PubMed 38970004
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Conventional and Digital Implant Impression Techniques in Bilateral Distal Extension Cases
- ClinicalTrials.gov ID
- NCT05912725
- Acronym / sponsor ID
- RP-9-20-1
- Conditions
- Partial Edentulism Class 1
- Keywords
- Digital impression, implant impression, impression accuracy, Digital work flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 22 Jun 2023 (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.
The purpose was to evaluate the accuracy of traditional and digital implant level impression procedures by using three-dimensional superimposition analysis , and evaluate the passive fit of screw- retained implant supported restorations fabricated using conventional and digital impression techniques in bilateral distal extension cases (class I kennedy classification)
Detailed description
Eight patients who had missing all mandibular posterior teeth except first premolars were included in this study. In each patient, 4 implants were placed, 2 in each side to support 3 units screw retained zirconia restorations. Three months after implant placement, each patient underwent two implant level impression techniques (n=8) for each technique: Conventional implant impressions CII (pick-up, splinted transfers), and digital implant impressions DII were captured with TRIOS 3 Shape intraoral optical scanner. In this study, digital impression was considered as a reference data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accuracy of Implant impression techniques | Experimental | Procedure: Implant placementActive comparative : digital implant impression Participants underwent intra-oral scanning digital impression Experimental : conventional implant impression Participants underwent conventional impressions And right side of pt mouth received screw retained prosthesis constructed from conventional impression left side received screws retained prosthesis constructed from digital impression |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All participants have sufficient bone length and width for implant insertion.
- General health of the patients was evaluated by taking a full medical history to ensure that these patients were free from any systemic conditions that would have impaired implant osseointegration
- Good oral hygiene
- Sufficient inter-arch spaces
- The opposing arch was almost dentulous, and any missing teeth were restored using a fixed partial denture.
Key exclusion criteria (5 listed)
- parafunctional habits
- Heavy smoking
- Those patients with systemic diseases that may influence soft or hard tissue healing.
- Patients with a history of radiation therapy in the head and neck region.
- Patients with a history of radiation therapy in the head and neck region.
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 |
|---|---|---|
| Implant placement4 implants were placed , 2 implants in each side of the patient mouth opposite lower second premolar and second molar 4 implants were placed , 2 implants in each side of the patient mouth opposite lower second premolar and second molar | Procedure or surgery | Accuracy of Implant impression techniques |
Primary outcome
Accuracy of digital and conventional implant impression techniques in partially edentulous patient
Time frame: 12 months
GOM Inspect 2016, Gom GmbH,) that was used to superimpose the Standard tessellation language (STL) datasets of conventional open tray impression technique onto the STL file of the reference (digital implant impression technique) to assess the accuracy and calculate the three-dimensional deviations of scan bodies in color- coding map in micrometers (µm)
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 22 Jun 2023.
- Derived from this study: PubMed 38970004Elashry WY, Elsheikh MM, Elsheikh AM. Evaluation of the accuracy of conventional and digital implant impression techniques in bilateral distal extension cases: a randomized clinical trial. BMC Oral Health. 2024 Jul 5;24(1):764. doi: 10.1186/s12903-024-04495-0.
- 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.
Wafaa Y El ashry, MSc principal investigator
Tanta university ,Faculty of Dentistry, Prosthodontics department
Wafaa Y El ashry principal investigator
Tanta university, Faculty of Dentistry, Prosthodontics department
Wafaa Y El ashry, MSc principal investigator
Tanta 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 Implant placement in people with Partial Edentulism Class 1, run by Tanta University 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 5 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 22 Jun 2023. 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?
Accuracy of digital and conventional implant impression techniques in partially edentulous patient (time frame: 12 months). 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 NCT05912725, which also lists 1 linked publication.
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 22 Jun 2023.