Jaw, EdentulousNCT05709236
Digital Versus Conventional Full-arch Implant Impression in Maxillary Screw- Retained Implant Prosthesis
A study testing Maxillary screw-retained prosthesis in people with Jaw, Edentulous, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
28 participants with edentulous maxillary arches were randomly selected and enrolled in two equal groups; Group I conventional impression group (CIG) and Group II Digital impression group (DIG). All patients were rehabilitated with maxillary screw-retained implant prosthesis retained by 6 implants. Read more about this study
- Who is it for?
- Ages 56 to 70 years
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- Maxillary screw-retained prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2020to 10 Aug 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 56 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with maxillary edentulous ridges opposing fully dentulous mandibular arch or with a minimum of six anterior teeth (canine to canine), and the utmost one or two premolar/molar missing in any quadrant
- patients with compromised facial/lip support seeking a fixed prosthesis for their edentulous maxilla
- having edentulous maxilla with adequate bone density and height to place six implants as assessed clinically and radiographically, and physically
- psychologically eligible patients for implants placement.
Who cannot join
- debarred medically compromised patients
- smokers
- patients suffering from parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Maxillary Screw-retained Implant Prosthesis Fabricated From Digital Versus Conventional Full-arch Implant Impression: A Randomized Controlled Clinical Trial
28 participants with edentulous maxillary arches were randomly selected and enrolled in two equal groups; Group I conventional impression group (CIG) and Group II Digital impression group (DIG). All patients were rehabilitated with maxillary screw-retained implant prosthesis retained by 6 implants. Prosthodontic complications and peri-implant MBL were registered at 6,12, and 24 months (m). Data was collected and statistically analyzed.
Read the detailed description
Treatment sequence Pretreatment examination For all participants, diagnosis and treatment planning were performed. They were assessed clinically through oral examination by inspection and palpation, and radiographically using preoperative panoramic radiograph and cone beam computed tomography CBCT to evaluate bone morphology, bone height, bone density, and vertical as well as horizontal bone resorption.
New maxillary complete dentures were fabricated for all participants to serve as temporization and to perform prosthetically driven computer guided implant placement. Preoperative CBCT scan (i-CAT Visions; Imaging Sciences International, Hatfield, PA, USA) was performed for all participants using the newly fabricated dentures with extra oral ready-made radiopaque markers. The markers were placed in relation to the maxillary dentures laterals/canines position, first premolars position, and first molars position. The superimposition of these markers on the maxilla determines the potential implants sites. Implant planning was performed and a stereolithographic surgical guide was fabricated with 6 sleeves on these preplanned implants sites.
Surgical procedures Computer-guided surgery was performed; each participant of both groups received six axially placed implants (Neobiotech, South korea) in the preplanned implant positions in maxilla. The final insertion torque for implants was 40 N cm. Post-operative instructions were given for patients. Chlorhexidine mouth wash 0.2% was prescribed for two weeks.
Prosthetic procedures Patients of both groups were recalled after a healing period of soft and hard tissues of four months for second stage surgery. Transmucosal titanium abutments were screwed in after uncovering of the six implants. For the fabrication of the definitive prosthesis, two different approaches were implemented: conventional pick up versus digital impressions.
For group I patients (CIG), a conventional open tray full- arch implant impression was implemented to fabricate the definitive maxillary screw retained prosthesis. Six long impression transfers were screwed over the fixtures. Using a periapical radiographs the seating of the open-tray long impression copings was confirmed. Splinting of impression copings was performed using special resin (Duralay; Reliance Dental, Alsip, IL, USA) (Fig----). Conventional border molding of the custom open trays (Fig----) was performed, then light body vinyl polysiloxane (Imprint 3, 3M ESPE, St. Paul, MN, USA) was injected around the impression transfer (Fig---). The tray was then filled with a heavy body vinyl polysiloxane ((Imprint 3, 3M ESPE, St. Paul, MN, USA) and a conventional pick up impression was made. Implant analogues were then attached to the impression copings and stone models were pored to replicate the exact implant positions in the cast.
For group II patients (DIG), a digital full arch implant impression was utilized to fabricate the definitive maxillary screw retained prosthesis. A digital IOS (i-500®, Medit, Seoul, South Korea) and scan bodies (Neobiotech, South korea) replacing the traditional impression copings were used to capture accurately the implant fixtures. Splinting of the scan bodies was performed using the same technique employed for the impression transfers. The same experienced investigator performed the scanning of the splinted scan bodies applying the scanning stitching strategy 20.
Keeping the IOS light source parallel to the occlusal plane, scanning of the implants started from the distal left implant and then the IOS was moved toward the anterior right implant , and then moved back to the distal implant of the left quadrant, while tilting it palatally; followed by crossing the occlusal plan toward the buccal side.
The same scanning pathway was repeated from the starting scan point for each half. Inspection of the image and filling of the missing regions were performed by fast passages of the camera over the related areas.
Identical scanning of the other half was performed using consistent scanning procedures, from anterior left implant to the right distal implant of the contralateral quadrant. The software merges the two halves by applying a stitching algorithm which uses the shared area between the two anterior implants. Scanning of the soft tissues was then performed, and matching of the soft tissues and scan bodies of related components scans was achieved.
The "A.I. Scan Body Matching" feature was used in which the library data is aligned automatically with the scan data, minimizing the need to scan difficult-to-reach areas. Arranging and replacing that scan body data with the library data was completed to reproduce the position and angle of the implanted fixtures accurately.
Scanning of the opposing mandibular arch was accomplished using the same scanning procedures, followed by scanning of the buccal surface of the patients teeth in maximum intercuspation with the maxillary temporary denture.
The 3D scans created were then exported in STL format, uploaded and post processing accomplished. Accuracy of detail and correct occlusal relationship were evaluated for the virtual images and virtual models were created with dental implants in position.
Virtual digital creation of framework and prosthesis were performed using the CAD software (Exocad software, Darmstad, Germany) For both groups, milling of the definitive frameworks from titanium was performed in accordance with sending the rapid prototype model to the laboratory for the fabrication of the definitive prosthesis. The frameworks were seated and screwed to the implants fixtures and passive fit was ensured using Sheffield test. In none of the two groups the frameworks needed splitting and reassembling.
The prosthesis, set up for the esthetic trial placement, constituted by a framework and a suprastructure of esthetic material, has been refined in esthetics, function and in relation to soft tissues. After the esthetic and functional evaluation, the restoration is finalized, over the mesostructure the esthetic material has been added for the rebuilding of teeth with composite (NACERA HYBRID, DOCERAM Medical Ceramics GmbH, Dortmund, Germany) and soft tissues.
For both groups, the definitive prosthesis was cemented to the titanium mesostructured with a dual cure cement (Rely X Unicem, 3M, St. Paul, MN, USA), then positioning and screwing of the prosthesis onto the dental implants was accomplished and passive fit was ensured using the Sheffield test.
- Conditions
- Jaw, Edentulous
- Being tested
- Maxillary screw-retained prosthesis
- Keywords
- edentulous, implant, Screw retained, Digital impression
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary screw-retained prosthesisDevice
Maxillary screw-retained prosthesis with conventional full-arch impression with conventional or digital impression
| Study group | Role | What they receive |
|---|---|---|
| Completely edentulous maxillary arch digital impression | Experimental | treated with Maxillary screw-retained prosthesis with digital full-arch impression Receives: Device: Maxillary screw-retained prosthesis |
| Completely edentulous maxillary arch conventional impression | Active comparator | treated with Maxillary screw-retained prosthesis with conventional full-arch impression Receives: Device: Maxillary screw-retained prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of events of prosthodontic complications
For both groups, the prosthodontic complications of the maxillary screw-retained implant prosthesis were monitored and calculated during the twenty four months follow up period according to the following events: Loss of the cover of access hole, Framework fracture, Fractured acrylic resin, Prosthetic teeth fracture, Screw loosening of the abutment, Screw fracture of the abutment, Screw loosening of the prosthesis, Screw fracture of the prosthesis.
Measured: - 6 months, 12 months and 24 months
Secondary outcomes (1)
Amount of marginal bone loss
Peri-implant MBL was assessed for the 6-implants in both groups at 6, 12, and 24 months using standardized digital peri-apical radiograph with long cone paralleling technique. Mesial and distal MBL relative to each implant shoulder was assessed in millimeters, and the mean was calculated and statistically estimated. Image analysis was performed using the Digora software (Digora phosphor plate reader; soredex, Tuusula, Finland).
Measured: 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start5 Jan 2020
- Primary completion10 May 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, EdentulousStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Ibrahim, Delta University for Science and Technology
- Investigators
- Wafaa Ibrahim, PHD, Principal investigator, Assoc. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709236
- Sponsor's protocol ID
- FODMRC/2022/00103
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Maxillary Screw-retained Implant Prosthesis Fabricated From Digital Versus Conventional Full-arch Implant Impression: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05709236
- Acronym / sponsor ID
- FODMRC/2022/00103
- Conditions
- Jaw, Edentulous
- Keywords
- edentulous, implant, Screw retained, Digital impression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 2 Feb 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.
28 participants with edentulous maxillary arches were randomly selected and enrolled in two equal groups; Group I conventional impression group (CIG) and Group II Digital impression group (DIG). All patients were rehabilitated with maxillary screw-retained implant prosthesis retained by 6 implants. Prosthodontic complications and peri-implant MBL were registered at 6,12, and 24 months (m). Data was collected and statistically analyzed.
Detailed description
Treatment sequence Pretreatment examination For all participants, diagnosis and treatment planning were performed. They were assessed clinically through oral examination by inspection and palpation, and radiographically using preoperative panoramic radiograph and cone beam computed tomography CBCT to evaluate bone morphology, bone height, bone density, and vertical as well as horizontal bone resorption.
New maxillary complete dentures were fabricated for all participants to serve as temporization and to perform prosthetically driven computer guided implant placement. Preoperative CBCT scan (i-CAT Visions; Imaging Sciences International, Hatfield, PA, USA) was performed for all participants using the newly fabricated dentures with extra oral ready-made radiopaque markers. The markers were placed in relation to the maxillary dentures laterals/canines position, first premolars position, and first molars position. The superimposition of these markers on the maxilla determines the potential implants sites. Implant planning was performed and a stereolithographic surgical guide was fabricated with 6 sleeves on these preplanned implants sites.
Surgical procedures Computer-guided surgery was performed; each participant of both groups received six axially placed implants (Neobiotech, South korea) in the preplanned implant positions in maxilla. The final insertion torque for implants was 40 N cm. Post-operative instructions were given for patients. Chlorhexidine mouth wash 0.2% was prescribed for two weeks.
Prosthetic procedures Patients of both groups were recalled after a healing period of soft and hard tissues of four months for second stage surgery. Transmucosal titanium abutments were screwed in after uncovering of the six implants. For the fabrication of the definitive prosthesis, two different approaches were implemented: conventional pick up versus digital impressions.
For group I patients (CIG), a conventional open tray full- arch implant impression was implemented to fabricate the definitive maxillary screw retained prosthesis. Six long impression transfers were screwed over the fixtures. Using a periapical radiographs the seating of the open-tray long impression copings was confirmed. Splinting of impression copings was performed using special resin (Duralay; Reliance Dental, Alsip, IL, USA) (Fig----). Conventional border molding of the custom open trays (Fig----) was performed, then light body vinyl polysiloxane (Imprint 3, 3M ESPE, St. Paul, MN, USA) was injected around the impression transfer (Fig---). The tray was then filled with a heavy body vinyl polysiloxane ((Imprint 3, 3M ESPE, St. Paul, MN, USA) and a conventional pick up impression was made. Implant analogues were then attached to the impression copings and stone models were pored to replicate the exact implant positions in the cast.
For group II patients (DIG), a digital full arch implant impression was utilized to fabricate the definitive maxillary screw retained prosthesis. A digital IOS (i-500®, Medit, Seoul, South Korea) and scan bodies (Neobiotech, South korea) replacing the traditional impression copings were used to capture accurately the implant fixtures. Splinting of the scan bodies was performed using the same technique employed for the impression transfers. The same experienced investigator performed the scanning of the splinted scan bodies applying the scanning stitching strategy 20.
Keeping the IOS light source parallel to the occlusal plane, scanning of the implants started from the distal left implant and then the IOS was moved toward the anterior right implant , and then moved back to the distal implant of the left quadrant, while tilting it palatally; followed by crossing the occlusal plan toward the buccal side.
The same scanning pathway was repeated from the starting scan point for each half. Inspection of the image and filling of the missing regions were performed by fast passages of the camera over the related areas.
Identical scanning of the other half was performed using consistent scanning procedures, from anterior left implant to the right distal implant of the contralateral quadrant. The software merges the two halves by applying a stitching algorithm which uses the shared area between the two anterior implants. Scanning of the soft tissues was then performed, and matching of the soft tissues and scan bodies of related components scans was achieved.
The "A.I. Scan Body Matching" feature was used in which the library data is aligned automatically with the scan data, minimizing the need to scan difficult-to-reach areas. Arranging and replacing that scan body data with the library data was completed to reproduce the position and angle of the implanted fixtures accurately.
Scanning of the opposing mandibular arch was accomplished using the same scanning procedures, followed by scanning of the buccal surface of the patients teeth in maximum intercuspation with the maxillary temporary denture.
The 3D scans created were then exported in STL format, uploaded and post processing accomplished. Accuracy of detail and correct occlusal relationship were evaluated for the virtual images and virtual models were created with dental implants in position.
Virtual digital creation of framework and prosthesis were performed using the CAD software (Exocad software, Darmstad, Germany) For both groups, milling of the definitive frameworks from titanium was performed in accordance with sending the rapid prototype model to the laboratory for the fabrication of the definitive prosthesis. The frameworks were seated and screwed to the implants fixtures and passive fit was ensured using Sheffield test. In none of the two groups the frameworks needed splitting and reassembling.
The prosthesis, set up for the esthetic trial placement, constituted by a framework and a suprastructure of esthetic material, has been refined in esthetics, function and in relation to soft tissues. After the esthetic and functional evaluation, the restoration is finalized, over the mesostructure the esthetic material has been added for the rebuilding of teeth with composite (NACERA HYBRID, DOCERAM Medical Ceramics GmbH, Dortmund, Germany) and soft tissues.
For both groups, the definitive prosthesis was cemented to the titanium mesostructured with a dual cure cement (Rely X Unicem, 3M, St. Paul, MN, USA), then positioning and screwing of the prosthesis onto the dental implants was accomplished and passive fit was ensured using the Sheffield test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Completely edentulous maxillary arch digital impression | Experimental | Device: Maxillary screw-retained prosthesistreated with Maxillary screw-retained prosthesis with digital full-arch impression |
| Completely edentulous maxillary arch conventional impression | Active comparator | Device: Maxillary screw-retained prosthesistreated with Maxillary screw-retained prosthesis with conventional full-arch impression |
Who may qualify
- Ages
- 56 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with maxillary edentulous ridges opposing fully dentulous mandibular arch or with a minimum of six anterior teeth (canine to canine), and the utmost one or two premolar/molar missing in any quadrant
- patients with compromised facial/lip support seeking a fixed prosthesis for their edentulous maxilla
- having edentulous maxilla with adequate bone density and height to place six implants as assessed clinically and radiographically, and physically
- psychologically eligible patients for implants placement.
Key exclusion criteria (3 listed)
- debarred medically compromised patients
- smokers
- patients suffering from 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 |
|---|---|---|
| Maxillary screw-retained prosthesisMaxillary screw-retained prosthesis with conventional full-arch impression with conventional or digital impression | Device | Completely edentulous maxillary arch conventional impression, Completely edentulous maxillary arch digital impression |
Primary outcome
Number of events of prosthodontic complications
Time frame: - 6 months, 12 months and 24 months
For both groups, the prosthodontic complications of the maxillary screw-retained implant prosthesis were monitored and calculated during the twenty four months follow up period according to the following events: Loss of the cover of access hole, Framework fracture, Fractured acrylic resin, Prosthetic teeth fracture, Screw loosening of the abutment, Screw fracture of the abutment, Screw loosening of the prosthesis, Screw fracture of the prosthesis.
1 secondary outcome
Amount of marginal bone loss
Time frame: 6 months, 12 months and 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 2 Feb 2023.
- 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 Ibrahim, PHD principal investigator
Assoc. Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary screw-retained prosthesis in people with Jaw, Edentulous, run by Delta University for Science and Technology 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 4 inclusion and 3 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 2 Feb 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?
Number of events of prosthodontic complications (time frame: - 6 months, 12 months and 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 2 Feb 2023.