Implant ComplicationNCT06071676
Digital Versus Conventional Impression CAD\CAM Constructed 4- Implant Supported Mandibular Overdenture Base
A study testing conventional impression group and digital impression group in people with Implant Complication, run by Mansoura University at 1 site in Egypt.
Trial summary
This clinical study was done to compare between digital with conventional impression used in the CAD/CAM constructed 4- implant supported mandibular overdenture base regarding their effect on the bone height changes Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- conventional impression group and digital impression group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2022to 7 Feb 2023
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patient wearing maxillary conventional denture.
- All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
- A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
- They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
- At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
- All patients are of angel's class I maxillo-mandibular relationships.
Who cannot join
- Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
- Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
- Long term immunosuppress and corticosteroid drug therapy.
- Patient with abnormal habits as clenching and bruxism.
- Smoking patient.
- Uncooperative patients.
- Neuromuscular diseases.
- Patient with problems in TMJ.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Versus Conventional Impression Used in The CAD / CAM Constructed 4- Implant Supported Mandibular Overdenture Base: Bone Height Changes
This clinical study was done to compare between digital with conventional impression used in the CAD/CAM constructed 4- implant supported mandibular overdenture base regarding their effect on the bone height changes
Read the detailed description
The patients were classified randomly into two equal groups according to impression techniques of mandibular implants and residual ridge:
Group 1: conventional impression group (CIG). Group 2: digital impression group (DIG).
For group 1 :
- Unscrew the provisional acrylic denture from the implants . - The long transfer copings (implant level) were screwed to the implants.
- The transfer copings were splinted with orthodontic ligature wire and light cure composite resin before impression making to prevent movement of the transfer coping during impression procedure.
- A stock/special tray was perforated to allow passing of the transfer copings through it without interference and permit unscrewing of the transfer after setting of the impression
- - If there is large opening occurred, the opening was closed off using base plate wax to support the impression material, with the guide pins perforating the wax
- - Inject the light body rubber base impression around the transfer coping. Fill the tray with a heavy body impression material and insert it intraorally till the tips of all the guide pins are appeared, clean the guide pin access holes from excess impression material.
- Unscrew the long transfer coping from the opining of the tray to allow it to be removed with the impression material.
- Implant analogues was screwed into the transfer coping.
- The impression was poured to obtain master cast then attachments(ball and socket attachments) were screwed to the implant analogues and metal housings placed on their position on master cast.
- The lower master cast was scanned using extra oral 3D scanner (DOF Swing dental scanner, Correa) to obtain the standard tessellation language (STL) file format.
For group 2 :
- A digital scanner (shining 3D scanner, Germany) was utilized to fabricate the definitive prostheses. The attachments were screwed to the implants intra orally and metal housing on their position which scanned by using intra oral scanner.
- Intra oral scanner transformed into a virtual volume the three-dimensional geometry of dental arches using the principle of structured light. A scanning stitching strategy carried out by the same experienced investigator and applied to DIG group for the attachments on their position on implants.
- IOS light source formerly kept parallel to the occlusal plane and started from the distal implant of the left quadrant and moved toward the anterior implant of the contralateral quadrant (right side); it was then moved back to the distal implant of the left side, tilting it toward the palatal side; the occlusal plane was crossed toward the buccal side and the camera moved again from the starting scanning point of the left side to the anterior implant of the right side trying to keep it perpendicular to the occlusal plane.
- The image was then inspected and missing regions were filled by fast passages of the camera over the related areas.
- The same scanning procedure was performed with the other half, from the anterior implant of the left quadrant to the distal implant of the contralateral quadrant (right side).
- The software automatically was applied a stitching algorithm in order to merge the two halves, based on the area between the two anterior implants, shared by both the separate scans.
- The virtual model was created of the dental implant and attachments in position which used to obtain 3d printed master cast by using 3D printer (WANHAO desktop 3D printer, Zhejiang, China).
Then for both groups
- After approval of the virtual design preview of the permanent denture base by the investigator and technician, a pre polymerized denture base material (Ava Dent Digital Dental solutions HQ, Scottsdale, USA) were fabricated by CAD-CAM milling machine (DENTSPLY Sirona In Lab MC X5 laboratory milling machine, Germany) according to manufacturer' instructions.
- The denture base was milled from Pre-polymerized CAD-CAM PMMA acrylic plates (98-mm diameter×25-mm thick) by using milling machine.
- After the CAD-CAM permanent denture base milled, female parts (metal housing) of the attachments cemented on the prepared positions on the fitting surface of the denture base by using dual cure glass ionomer resin cement extra orally and cement excess removed from the lingual vents on the prepared positions of metal housing .
- Record blocks were constructed on the master casts and used to record Maxillo-mandibular jaw relation by using milled permanent denture base.
- Mounting of the maxillary cast was done on a semi-adjustable articulator† by the aid of maxillary face bow and the mandibular cast mounting was done in relation to the maxillary cast by centric inter occlusal wax wafer record.
- Protrusive wax record was used for adjusting the horizontal condylar angle of the semi adjustable articulator, while the lateral condylar angle was adjusted according to Hanau equation: L = H / 8 + 12. Where H represents the horizontal condylar path inclination in degrees as established by a protrusive record and L represents the lateral condylar path inclination in degrees.
- Maxillary anatomical and mandibular flat acrylic teeth‡ were arranged for lingualized balanced occlusion and try in was done in the patient's mouth.
- For the lower permanent denture base teeth cemented on their positions by using self cure acrylic resin .
- For the upper denture , flasking and processing was done into heat cured acrylic resin by the long curing cycle.
- After finishing and polishing, the dentures were remounted to adjust any occlusal discrepancies and to ensure proper contact in centric and eccentric positions. Final adjustment of the occlusion was done intraorally.
- The patient was instructed for proper insertion, removal, home care and hygiene and to use the denture until the evaluation session.
- Conditions
- Implant Complication
- Being tested
- conventional impression group, digital impression group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional impression groupOther
Silicon impression material loaded on plastic tray and inserted inside the patient mouth
digital impression groupOther
direct scanning was done using intraoral scanner to the female housing of the attachments on position
| Study group | Role | What they receive |
|---|---|---|
| conventional impression procedures | Other | Implant analogues were screwed to the transfer copings inside the impression and the master cast were obtained. Attachments were screwed to the analogues and metal housing wasplaced on their position on master cast. Master cast will be scanned extra orally to obtain STL file of the master cast. Receives: Other: conventional impression group |
| digital impression procedures | Other | A digital scanner (shining 3D scanner, Germany) was utilized to fabricate the definitive prostheses. The attachments were screwed to the implants intra orally and metal housing on their position which scanned by using intra oral scanner.
* Intra oral scanner transformed into a virtual volume the three-dimensional geometry of dental arches using the principle of structured light. A scanning stitching strategy carried out by the same experienced investigator and applied to DIG group for the attachments on their position on implants.
* The software automatically was applied a stitching algorithm in order to merge the two halves, based on the area between the two anterior implants, shared by both the separate scans.
* The virtual model was created of the dental implant and attachments in position which used to obtain 3d printed master cast by using 3D printer (WANHAO desktop 3D printer, Zhejiang, China). Receives: Other: digital impression group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone height changes
Long cone paralleling technique and a film holder designed specifically for implant imaging were used for intraoral radiograph. To maintain the same film- implant distance and cone implant distance, a modification was carried out for the film holder. This modification is a hole drilled exactly above the implant fixture so the distance was maintained during subsequent film exposures. A long screw of the impression coping was used to secure the holder to the implant. Through this modification, standardized radiographs were achieved.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start20 Feb 2022
- Primary completion6 Jan 2023
- Study completion7 Feb 2023
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 Implant ComplicationStudies 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
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohamed fouad, professor, Principal investigator, specify Unaffiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071676
- Sponsor's protocol ID
- M01010322
- Status last verified
- Feb 2022
- First submitted
- 1 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goracci C, Franchi L, Vichi A, Ferrari M. Accuracy, reliability, and efficiency of intraoral scanners for full-arch impressions: a systematic review of the clinical evidence. Eur J Orthod. 2016 Aug;38(4):422-8. doi: 10.1093/ejo/cjv077. Epub 2015 Oct 20.
PubMed 26487391
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Versus Conventional Impression Used in The CAD / CAM Constructed 4- Implant Supported Mandibular Overdenture Base: Bone Height Changes
- ClinicalTrials.gov ID
- NCT06071676
- Acronym / sponsor ID
- M01010322
- Conditions
- Implant Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 6 Oct 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.
This clinical study was done to compare between digital with conventional impression used in the CAD/CAM constructed 4- implant supported mandibular overdenture base regarding their effect on the bone height changes
Detailed description
The patients were classified randomly into two equal groups according to impression techniques of mandibular implants and residual ridge:
Group 1: conventional impression group (CIG). Group 2: digital impression group (DIG).
For group 1 :
- Unscrew the provisional acrylic denture from the implants . - The long transfer copings (implant level) were screwed to the implants.
- The transfer copings were splinted with orthodontic ligature wire and light cure composite resin before impression making to prevent movement of the transfer coping during impression procedure.
- A stock/special tray was perforated to allow passing of the transfer copings through it without interference and permit unscrewing of the transfer after setting of the impression
- - If there is large opening occurred, the opening was closed off using base plate wax to support the impression material, with the guide pins perforating the wax
- - Inject the light body rubber base impression around the transfer coping. Fill the tray with a heavy body impression material and insert it intraorally till the tips of all the guide pins are appeared, clean the guide pin access holes from excess impression material.
- Unscrew the long transfer coping from the opining of the tray to allow it to be removed with the impression material.
- Implant analogues was screwed into the transfer coping.
- The impression was poured to obtain master cast then attachments(ball and socket attachments) were screwed to the implant analogues and metal housings placed on their position on master cast.
- The lower master cast was scanned using extra oral 3D scanner (DOF Swing dental scanner, Correa) to obtain the standard tessellation language (STL) file format.
For group 2 :
- A digital scanner (shining 3D scanner, Germany) was utilized to fabricate the definitive prostheses. The attachments were screwed to the implants intra orally and metal housing on their position which scanned by using intra oral scanner.
- Intra oral scanner transformed into a virtual volume the three-dimensional geometry of dental arches using the principle of structured light. A scanning stitching strategy carried out by the same experienced investigator and applied to DIG group for the attachments on their position on implants.
- IOS light source formerly kept parallel to the occlusal plane and started from the distal implant of the left quadrant and moved toward the anterior implant of the contralateral quadrant (right side); it was then moved back to the distal implant of the left side, tilting it toward the palatal side; the occlusal plane was crossed toward the buccal side and the camera moved again from the starting scanning point of the left side to the anterior implant of the right side trying to keep it perpendicular to the occlusal plane.
- The image was then inspected and missing regions were filled by fast passages of the camera over the related areas.
- The same scanning procedure was performed with the other half, from the anterior implant of the left quadrant to the distal implant of the contralateral quadrant (right side).
- The software automatically was applied a stitching algorithm in order to merge the two halves, based on the area between the two anterior implants, shared by both the separate scans.
- The virtual model was created of the dental implant and attachments in position which used to obtain 3d printed master cast by using 3D printer (WANHAO desktop 3D printer, Zhejiang, China).
Then for both groups
- After approval of the virtual design preview of the permanent denture base by the investigator and technician, a pre polymerized denture base material (Ava Dent Digital Dental solutions HQ, Scottsdale, USA) were fabricated by CAD-CAM milling machine (DENTSPLY Sirona In Lab MC X5 laboratory milling machine, Germany) according to manufacturer' instructions.
- The denture base was milled from Pre-polymerized CAD-CAM PMMA acrylic plates (98-mm diameter×25-mm thick) by using milling machine.
- After the CAD-CAM permanent denture base milled, female parts (metal housing) of the attachments cemented on the prepared positions on the fitting surface of the denture base by using dual cure glass ionomer resin cement extra orally and cement excess removed from the lingual vents on the prepared positions of metal housing .
- Record blocks were constructed on the master casts and used to record Maxillo-mandibular jaw relation by using milled permanent denture base.
- Mounting of the maxillary cast was done on a semi-adjustable articulator† by the aid of maxillary face bow and the mandibular cast mounting was done in relation to the maxillary cast by centric inter occlusal wax wafer record.
- Protrusive wax record was used for adjusting the horizontal condylar angle of the semi adjustable articulator, while the lateral condylar angle was adjusted according to Hanau equation: L = H / 8 + 12. Where H represents the horizontal condylar path inclination in degrees as established by a protrusive record and L represents the lateral condylar path inclination in degrees.
- Maxillary anatomical and mandibular flat acrylic teeth‡ were arranged for lingualized balanced occlusion and try in was done in the patient's mouth.
- For the lower permanent denture base teeth cemented on their positions by using self cure acrylic resin .
- For the upper denture , flasking and processing was done into heat cured acrylic resin by the long curing cycle.
- After finishing and polishing, the dentures were remounted to adjust any occlusal discrepancies and to ensure proper contact in centric and eccentric positions. Final adjustment of the occlusion was done intraorally.
- The patient was instructed for proper insertion, removal, home care and hygiene and to use the denture until the evaluation session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional impression procedures | Other | Other: conventional impression groupImplant analogues were screwed to the transfer copings inside the impression and the master cast were obtained. Attachments were screwed to the analogues and metal housing wasplaced on their position on master cast. Master cast will be scanned extra orally to obtain STL file of the master cast. |
| digital impression procedures | Other | Other: digital impression groupA digital scanner (shining 3D scanner, Germany) was utilized to fabricate the definitive prostheses. The attachments were screwed to the implants intra orally and metal housing on their position which scanned by using intra oral scanner. * Intra oral scanner transformed into a virtual volume the three-dimensional geometry of dental arches using the principle of structured light. A scanning stitching strategy carried out by the same experienced investigator and applied to DIG group for the attachments on their position on implants. * The software automatically was applied a stitching algorithm in order to merge the two halves, based on the area between the two anterior implants, shared by both the separate scans. * The virtual model was created of the dental implant and attachments in position which used to obtain 3d printed master cast by using 3D printer (WANHAO desktop 3D printer, Zhejiang, China). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All patient wearing maxillary conventional denture.
- All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
- A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
- They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
- At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
Key exclusion criteria (8 listed)
- Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
- Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
- Long term immunosuppress and corticosteroid drug therapy.
- Patient with abnormal habits as clenching and bruxism.
- Smoking patient.
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 |
|---|---|---|
| conventional impression groupSilicon impression material loaded on plastic tray and inserted inside the patient mouth | Other | conventional impression procedures |
| digital impression groupdirect scanning was done using intraoral scanner to the female housing of the attachments on position | Other | digital impression procedures |
Primary outcome
Bone height changes
Time frame: one year
Long cone paralleling technique and a film holder designed specifically for implant imaging were used for intraoral radiograph. To maintain the same film- implant distance and cone implant distance, a modification was carried out for the film holder. This modification is a hole drilled exactly above the implant fixture so the distance was maintained during subsequent film exposures. A long screw of the impression coping was used to secure the holder to the implant. Through this modification, standardized radiographs were achieved.
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 17 Oct 2023.
- Results publication: PubMed 26487391Goracci C, Franchi L, Vichi A, Ferrari M. Accuracy, reliability, and efficiency of intraoral scanners for full-arch impressions: a systematic review of the clinical evidence. Eur J Orthod. 2016 Aug;38(4):422-8. doi: 10.1093/ejo/cjv077. Epub 2015 Oct 20.
- Accuracy, reliability, and efficiency of intraoral scanners for full-arch impressionsLink provided by the sponsor.
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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.
mohamed fouad, professor principal investigator
specify Unaffiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional impression group and digital impression group in people with Implant Complication, run by Mansoura 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 6 inclusion and 8 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 17 Oct 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?
Bone height changes (time frame: one year). 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 NCT06071676, 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 17 Oct 2023.