Immediate Dental ImplantsRCTNCT03287934
Accuracy of Selective Laser Sinteredcomputer Guided Stents Versus Digital Light Processing Stents
A study testing selective laser sintered stent and digital light processing(dlp) in people with Immediate Dental Implants, run by Cairo University at 1 site in Egypt.
Trial summary
patient with non-restorable tooth in the esthetic zone will be recruited in the study. a traumatic is done and implant will be placed using either digital light processed guides for control group or selective laser sintering group for intervention group. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implants
- What is being tested?
- selective laser sintered stent and digital light processing(dlp)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 11 Feb 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age should be more than 18 years old
- Hopeless tooth in esthetic zone due to caries, endodontical problem or trauma with both neighboring teeth present.
- Good oral hygiene
- No periapical lesions (acute accesses or chronic fistula)
- Adequate bone (5 mm) below the tooth to allow primary implant stability
- Sufficient Medio-distal bone about 1.5 from each side
- sufficient labial bone
- sufficient band of keratinized mucosa
Who cannot join
- heavy smoking
- any systemic condition that is considered absolute contraindication for implant placement
- pregnancy
- in adequate inter-arch space
- parafunctional habits as bruxism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Selective Laser Sintered Computer Guided Stents Versus Digital Light Processing Stents in Immediate Implant Placement in Esthetic Zone, a Randomized Controlled Study
patient with non-restorable tooth in the esthetic zone will be recruited in the study. a traumatic is done and implant will be placed using either digital light processed guides for control group or selective laser sintering group for intervention group.
Read the detailed description
the principle investigator will randomize and equally distribute the Eligible patients between the selective laser sintering group (intervention group) and digital light processing group (control group).
- Diagnostic phase : for initial diagnosis, principle investigator will make primary impression , bite registration, face bow record and periapical x-ray for each eligible patients. The tooth to be extracted will be removed from the cast and replaced with an artificial tooth. For construction of radio graphic stent, a clear thermoplastic sheet will be pressed on the modified cast using a vacuum forming machine . A hole is done in the center of the artificial tooth packed with heated gutta percha (radiopaque material) for easy visualization on the cone beam during virtual implant placing. A dual scan protocol with cone beam CT will be made. The first scan is for the patient wearing the scan appliance while the second will be for the cast with the scan appliance.
- Planning phase : placing of the virtual implant and designing of the surgical stent will be done by virtual planning software .
- Construction of the surgical guide: principle investigator will send the Standard Language transformation (STL) file of the designed guide to a rapid prototyping center. Selective laser sintering and digital light procesing will be used for intervention and control group respectively. principle investigator will check for adaption of the guide on the cast and cement the metallic sleeve to prevent rotation during surgery.
- Surgical phase : principle investigator will prescribe a prophylactic antibiotic to the patient three days prior the surgery. Atraumatic extraction will be carried by periotomes and lancet. The integrity of the socket will be examined well by probe. The guide is stabilized in its place then drilling and implant placement will be done. Healing abutment is screwed in place to allow proper healing of the soft tissue. Patient will be instructed to avoid hard foods and follow restrict oral hygiene measures. Patient will be recalled after one week for postoperative inspection and assessment. A cone beam CT will be taken for deviation assessment.
- Conditions
- Immediate Dental Implants
- Being tested
- selective laser sintered stent, digital light processing(dlp)
- Keywords
- selective laser sintering, digital light processing stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective laser sintered stentDevice
Also called Mega selective laser sintering (brand name )
after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with selective laser sintering technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done.
digital light processing(dlp)Device
Also called mogassam (brand name)
after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with digital light processing technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done.
| Study group | Role | What they receive |
|---|---|---|
| digital light processing stent | Experimental | according to the allocation, the experimental group will receive a digital light processing stent for immediate implant drilling and placement after atraumatic extraction of the target tooth. Receives: Device: selective laser sintered stent; Device: digital light processing(dlp) |
| selective laser sintering | Active comparator | according to the allocation, the intervention for the control group will be a selective laser sintering stent after atraumatic extraction of the target tooth for immediately implant placement. the selective laser sintering stent will be adapted and drilling will be done through the stent. Receives: Device: selective laser sintered stent; Device: digital light processing(dlp) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of accuracy of implant placement clinical observation
measuring both angular and linear deviation of implants by virtual ruler in terms of mm
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Dec 2017
- Primary completion1 Jan 2020
- Study completion11 Feb 2020
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 Immediate Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahetab hamdi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287934
- Sponsor's protocol ID
- R.prosthodontic department
- Acronym
- RCT
- Status last verified
- Jul 2020
- First submitted
- 14 Sep 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abduo, J., Lyons, K. & Bennamoun, M., 2014. Trends in Computer-Aided Manufacturing in Prosthodontics: A Review of the Available Streams. International Journal of Dentistry, 2014, pp.1-15. Available at: http://www.hindawi.com/journals/ijd/2014/783948/. Alzoubi, Fawaz, Nima Massoomi, and A.N., 2016. Accuracy Assessment of Immediate and Delayed Implant Placements Using CAD/CAM Surgical Guides. Journal of Oral Implantology ., 42(5), pp.391-398. Arısan, V. et al., 2013. Implant Positioning Errors in Freehand and Computer-Aided Placement Methods: A Single-Blind Clinical Comparative Study. The International Journal of Oral & Maxillofacial Implants, 28(1), pp.190-204. Available at: http://www.quintpub.com/journals/find_article.php?doi=10.11607/jomi.2691.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Selective Laser Sintered Computer Guided Stents Versus Digital Light Processing Stents in Immediate Implant Placement in Esthetic Zone, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03287934
- Acronym / sponsor ID
- RCT / R.prosthodontic department
- Conditions
- Immediate Dental Implants
- Keywords
- selective laser sintering, digital light processing stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 19 Sep 2017 (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.
patient with non-restorable tooth in the esthetic zone will be recruited in the study. a traumatic is done and implant will be placed using either digital light processed guides for control group or selective laser sintering group for intervention group.
Detailed description
the principle investigator will randomize and equally distribute the Eligible patients between the selective laser sintering group (intervention group) and digital light processing group (control group).
- Diagnostic phase : for initial diagnosis, principle investigator will make primary impression , bite registration, face bow record and periapical x-ray for each eligible patients. The tooth to be extracted will be removed from the cast and replaced with an artificial tooth. For construction of radio graphic stent, a clear thermoplastic sheet will be pressed on the modified cast using a vacuum forming machine . A hole is done in the center of the artificial tooth packed with heated gutta percha (radiopaque material) for easy visualization on the cone beam during virtual implant placing. A dual scan protocol with cone beam CT will be made. The first scan is for the patient wearing the scan appliance while the second will be for the cast with the scan appliance.
- Planning phase : placing of the virtual implant and designing of the surgical stent will be done by virtual planning software .
- Construction of the surgical guide: principle investigator will send the Standard Language transformation (STL) file of the designed guide to a rapid prototyping center. Selective laser sintering and digital light procesing will be used for intervention and control group respectively. principle investigator will check for adaption of the guide on the cast and cement the metallic sleeve to prevent rotation during surgery.
- Surgical phase : principle investigator will prescribe a prophylactic antibiotic to the patient three days prior the surgery. Atraumatic extraction will be carried by periotomes and lancet. The integrity of the socket will be examined well by probe. The guide is stabilized in its place then drilling and implant placement will be done. Healing abutment is screwed in place to allow proper healing of the soft tissue. Patient will be instructed to avoid hard foods and follow restrict oral hygiene measures. Patient will be recalled after one week for postoperative inspection and assessment. A cone beam CT will be taken for deviation assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital light processing stent | Experimental | Device: selective laser sintered stent, Device: digital light processing(dlp)according to the allocation, the experimental group will receive a digital light processing stent for immediate implant drilling and placement after atraumatic extraction of the target tooth. |
| selective laser sintering | Active comparator | Device: selective laser sintered stent, Device: digital light processing(dlp)according to the allocation, the intervention for the control group will be a selective laser sintering stent after atraumatic extraction of the target tooth for immediately implant placement. the selective laser sintering stent will be adapted and drilling will be done through the stent. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient age should be more than 18 years old
- Hopeless tooth in esthetic zone due to caries, endodontical problem or trauma with both neighboring teeth present.
- Good oral hygiene
- No periapical lesions (acute accesses or chronic fistula)
- Adequate bone (5 mm) below the tooth to allow primary implant stability
Key exclusion criteria (5 listed)
- heavy smoking
- any systemic condition that is considered absolute contraindication for implant placement
- pregnancy
- in adequate inter-arch space
- parafunctional habits as bruxism
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 |
|---|---|---|
| selective laser sintered stentAlso: Mega selective laser sintering (brand name )after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with selective laser sintering technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done. | Device | digital light processing stent, selective laser sintering |
| digital light processing(dlp)Also: mogassam (brand name)after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with digital light processing technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done. | Device | digital light processing stent, selective laser sintering |
Primary outcome
evaluation of accuracy of implant placement clinical observation
Time frame: 1 week
measuring both angular and linear deviation of implants by virtual ruler in terms of mm
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 28 Jul 2020.
- BackgroundAbduo, J., Lyons, K. & Bennamoun, M., 2014. Trends in Computer-Aided Manufacturing in Prosthodontics: A Review of the Available Streams. International Journal of Dentistry, 2014, pp.1-15. Available at: http://www.hindawi.com/journals/ijd/2014/783948/. Alzoubi, Fawaz, Nima Massoomi, and A.N., 2016. Accuracy Assessment of Immediate and Delayed Implant Placements Using CAD/CAM Surgical Guides. Journal of Oral Implantology ., 42(5), pp.391-398. Arısan, V. et al., 2013. Implant Positioning Errors in Freehand and Computer-Aided Placement Methods: A Single-Blind Clinical Comparative Study. The International Journal of Oral & Maxillofacial Implants, 28(1), pp.190-204. Available at: http://www.quintpub.com/journals/find_article.php?doi=10.11607/jomi.2691.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selective laser sintered stent and digital light processing(dlp) in people with Immediate Dental Implants, run by Cairo 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 8 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 28 Jul 2020. 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?
evaluation of accuracy of implant placement clinical observation (time frame: 1 week). 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 NCT03287934, 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 28 Jul 2020.