Immediate Dental ImplantsRCTNCT03281148
Accuracy in Computer Guided Versus Free Hand Immediate Implantation
A study testing Computer guided implant insertion group and Free hand implant insertion group in people with Immediate Dental Implants, run by Cairo University.
Trial summary
Patients with hopeless teeth in the esthetic area requiring immediate implant restoration will be recruited to the study. Patients will be divided into two groups; a group will receive immediate implants placed using CAD/CAM guides while the other group will receive immediate implants placed by free hand technique. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implants
- What is being tested?
- Computer guided implant insertion group and Free hand implant insertion group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Sep 2019
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with hopeless teeth or remaining roots
- Bucco-lingual bone thickness of 7mm or more (Spray et al., 2000)
- Bucco-lingual keratinized mucosa of 6mm or more (Spray et al., 2000)
- Inter-arch space sufficient for prosthetic rehabilitation (7mm or more) (Misch, 2008)
- Adults more than 18 years old
Who cannot join
- Uncontrolled diabetic patients (HbA1c value ≥ 8.1 percent) (Takeshita et al., 1998)(Javed \& Romanos, 2009)(Garg, 2010)(Retzepi \& Donos, 2010)(B R Chrcanovic et al., 2014)
- Heavy smokers (More than 10 cigarettes per day) (Nitzan et al., 2005) (Strietzel et al., 2007) (Abt, 2009)(Bruno Ramos Chrcanovic et al., 2015)
- Severe bruxers (Lobbezoo et al., 2006) (Manfredini et al., 2011)(Lin et al., 2012)(Zhou et al., 2015)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Accuracy in Computer Guided Versus Free Hand Immediate Implant Placement in Fresh Extraction Sockets: a Randomized Controlled Clinical Trial
Patients with hopeless teeth in the esthetic area requiring immediate implant restoration will be recruited to the study. Patients will be divided into two groups; a group will receive immediate implants placed using CAD/CAM guides while the other group will receive immediate implants placed by free hand technique. Accuracy of inserted implants will be measured.
Read the detailed description
Interventions The principal investigator (DA) will diagnose all patients and select them according to inclusion and exclusion criteria.
The principal investigator (DA) will prepare all patients. Patient preparation will take few steps that are important for optimum planning of implant insertion and restoration. Actual treatment steps will start after preparation is done including; surgical and prosthetic procedures.
- Case history
- Medical history: The principal investigator (DA) will ask all patients about their present and previous systemic condition and any history of hospitalization or surgeries. Controlled diabetic patients will be asked to bring a recent blood glucose test. This includes both fasting/post prandial \&glycosylated hemoglobin test (Hemoglobin A1c) to evaluate their current status.
- Dental history: The principal investigator (DA) will ask all patients about past dental procedures including implants.
- Clinical examination <!-- -->
- Visual examination: The principal investigator (DA) will examine all patients extra orally to assess the temporomandibular joints, temporalis, and masseter muscle to help in detection of bruxism. Intraoral examination includes assessment of any pathological lesion (cyst/tumor) that may interfere with the planned implant treatment.
- Digital examination: The principal investigator (DA) will examine the soft tissue surrounding hopeless teeth digitally using index finger to confirm a firm mucosa free from any flabby tissue, absence of severe undercuts and absence of abnormal ridge contour. The principal investigator (DA) will examine the bone volume arbitrary using the two index fingers to confirm an adequate bucco-lingual bone width. The principal investigator (DA) will test tooth mobility of adjacent teeth using a periodontal probe to ensure that the remaining adjacent teeth are not mobile.
- Construction of scan appliance: The principal investigator (DA) will make primary upper and lower impressions for the selected patients using irreversible hydrocolloid impression material in stock trays of suitable sizes. The principal investigator (DA) will pour impressions using Type IV extra hard dental stone . The principal investigator (DA) will take a Face bow record and a diagnostic bite record for each patient using Utility Wax . A semi-adjustable articulator will be used for mounting. A diagnostic mock up for broken/ badly decayed teeth will be formed for needed patients. By pressing a clear thermoplastic sheet using a vacuum forming machine on the study cast of the patient; a vacuum formed template will be constructed containing radiopaque markers for easy superimposition later. The vacuum template is now considered the scan appliance.
- Patient Radiographic Imaging Every patient will be then sent for a CBCT scanning for the upper and/or lower arch. The patient will be instructed to wear the scan appliance during imaging. Midline will be adjusted using laser beam and a scout will be taken to the patient. The patient will be asked to stay still till the machine rotates around him/her. The cone beam computed tomography images will be obtained in Digital Imaging \& Communications in Medicine (DICOM) format on a compact disc.
- Virtual planning and construction of surgical guide
- Virtual Planning The CBCT image was used for the virtual surgical and prosthetic planning of implant placement using Blusky® software. First, the remaining and neighboring teeth will be segmented. This step helped in virtually inserting implants in an acceptable position in relation to neighboring teeth with respect to their crowns and roots. Virtual Setting will be done then virtual insertion of implants with appropriate sizes will be done with respect to the future prosthesis. Cautious respect to anatomical landmarks in the area of interest will be considered during planning. In the mandible; Mandibular canal will be simulated to be seen in both 2D and 3D views. In the maxilla; maxillary sinus lining will be checked in all views during implant positioning. A Virtual guide will be designed from the CBCT of the patient to be seated on neighboring teeth. The exported Standard Language transformation (STL) file of the virtual guide will be sent to labs centers by e-mail for construction.
- Surgical Procedures: The Principal investigator (DA) will extract the remaining root or tooth in an atraumatic procedure procedure using lancet, periotome, minimal force and rotational movement. After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement. In the test group, the computer guided surgical guide will be used for implant drilling and placement following the manufacturer's instructions. While in the control group, after tooth or root extraction implants will be placed free hand guided by the extraction sockets. Then in implants with primary stability (Insertion torque> 35 Ncm2), the final abutment will be placed and any further adjustment would be done immediately in the lab and re-positioned in place. The principal investigator (DA) will check the vacuum stent is in its place again intraorally, then a chair side tooth colored auto-polymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown. If any subject is to feel any movement in his/her temporary crown, an immediate phone call is to be done to (DA) to examine the cause of mobility (whether it is the crown only or the implant itself).
- Postoperative Care: The principal investigator (DA) will manage postoperative complications. The principal investigator (DA) will remove mobile temporary crowns and recement them. While mobile implants will be considered as early stage failed implants and it will be removed immediately. The patient will receive another implant at the same site after a proper healing period of at least 3 months during which he/she will be provided with a temporary removable partial denture for aesthetics.
- Conditions
- Immediate Dental Implants
- Being tested
- Computer guided implant insertion group, Free hand implant insertion group
- Keywords
- immediate implants, accuracy,extraction sockets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided implant insertion groupDevice
Implants will be immediately inserted in fresh extraction sockets using CAD/CAM guides
Free hand implant insertion groupDevice
Implants will be immediately inserted in fresh extraction sockets using free hand technique
| Study group | Role | What they receive |
|---|---|---|
| Computer guided implant insertion group | Experimental | According to the allocation, the experimental group will receive implants immediately placed in extraction sockets using CAD/CAM surgical guides. Receives: Device: Computer guided implant insertion group |
| Free hand implant insertion group | Active comparator | According to the allocation, the control group will receive implants immediately placed in extraction sockets using traditional free hand technique. Receives: Device: Free hand implant insertion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear Deviation
The amount of linear deviation was measured through three parameters; global, lateral and depth deviation. These parameters will be measured at the apical and coronal center in a mesiodistal and buccolingual plane.
Measured: two months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study startNov 2017 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohammed Ayman, Cairo University
- Investigators
- Maha ElKerdawy, Professor, Study chair, Professor at Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281148
- Sponsor's protocol ID
- Prosthetic department
- Acronym
- RCT
- Status last verified
- Sep 2017
- First submitted
- 10 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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), 391-398. http://doi.org/10.1002/smll.)) D'haese, J., Van De Velde, T., Komiyama, A., Hultin, M., & De Bruyn, H. (2012). Accuracy and complications using computer-designed stereolithographic surgical guides for oral rehabilitation by means of dental implants: a review of the literature. Clinical Implant Dentistry and Related Research, 14(3), 321-35. http://doi.org/10.1111/j.1708-8208.2010.00275.x Ortega-martínez, J., Pérez-pascual, T., Mareque-bueno, S., & Hernández-alfaro, F. (2012). Immediate implants following tooth extraction . A systematic review. Medicina Oral Patología Oral Y Cirugia Bucal- Oral Surgery Section, 17(2), e251-61. http://doi.org/10.4317/medoral.17469
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy in Computer Guided Versus Free Hand Immediate Implant Placement in Fresh Extraction Sockets: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03281148
- Acronym / sponsor ID
- RCT / Prosthetic department
- Conditions
- Immediate Dental Implants
- Keywords
- immediate implants, accuracy,extraction sockets
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 13 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.
Patients with hopeless teeth in the esthetic area requiring immediate implant restoration will be recruited to the study. Patients will be divided into two groups; a group will receive immediate implants placed using CAD/CAM guides while the other group will receive immediate implants placed by free hand technique. Accuracy of inserted implants will be measured.
Detailed description
Interventions The principal investigator (DA) will diagnose all patients and select them according to inclusion and exclusion criteria.
The principal investigator (DA) will prepare all patients. Patient preparation will take few steps that are important for optimum planning of implant insertion and restoration. Actual treatment steps will start after preparation is done including; surgical and prosthetic procedures.
- Case history
- Medical history: The principal investigator (DA) will ask all patients about their present and previous systemic condition and any history of hospitalization or surgeries. Controlled diabetic patients will be asked to bring a recent blood glucose test. This includes both fasting/post prandial \&glycosylated hemoglobin test (Hemoglobin A1c) to evaluate their current status.
- Dental history: The principal investigator (DA) will ask all patients about past dental procedures including implants.
- Clinical examination <!-- -->
- Visual examination: The principal investigator (DA) will examine all patients extra orally to assess the temporomandibular joints, temporalis, and masseter muscle to help in detection of bruxism. Intraoral examination includes assessment of any pathological lesion (cyst/tumor) that may interfere with the planned implant treatment.
- Digital examination: The principal investigator (DA) will examine the soft tissue surrounding hopeless teeth digitally using index finger to confirm a firm mucosa free from any flabby tissue, absence of severe undercuts and absence of abnormal ridge contour. The principal investigator (DA) will examine the bone volume arbitrary using the two index fingers to confirm an adequate bucco-lingual bone width. The principal investigator (DA) will test tooth mobility of adjacent teeth using a periodontal probe to ensure that the remaining adjacent teeth are not mobile.
- Construction of scan appliance: The principal investigator (DA) will make primary upper and lower impressions for the selected patients using irreversible hydrocolloid impression material in stock trays of suitable sizes. The principal investigator (DA) will pour impressions using Type IV extra hard dental stone . The principal investigator (DA) will take a Face bow record and a diagnostic bite record for each patient using Utility Wax . A semi-adjustable articulator will be used for mounting. A diagnostic mock up for broken/ badly decayed teeth will be formed for needed patients. By pressing a clear thermoplastic sheet using a vacuum forming machine on the study cast of the patient; a vacuum formed template will be constructed containing radiopaque markers for easy superimposition later. The vacuum template is now considered the scan appliance.
- Patient Radiographic Imaging Every patient will be then sent for a CBCT scanning for the upper and/or lower arch. The patient will be instructed to wear the scan appliance during imaging. Midline will be adjusted using laser beam and a scout will be taken to the patient. The patient will be asked to stay still till the machine rotates around him/her. The cone beam computed tomography images will be obtained in Digital Imaging \& Communications in Medicine (DICOM) format on a compact disc.
- Virtual planning and construction of surgical guide
- Virtual Planning The CBCT image was used for the virtual surgical and prosthetic planning of implant placement using Blusky® software. First, the remaining and neighboring teeth will be segmented. This step helped in virtually inserting implants in an acceptable position in relation to neighboring teeth with respect to their crowns and roots. Virtual Setting will be done then virtual insertion of implants with appropriate sizes will be done with respect to the future prosthesis. Cautious respect to anatomical landmarks in the area of interest will be considered during planning. In the mandible; Mandibular canal will be simulated to be seen in both 2D and 3D views. In the maxilla; maxillary sinus lining will be checked in all views during implant positioning. A Virtual guide will be designed from the CBCT of the patient to be seated on neighboring teeth. The exported Standard Language transformation (STL) file of the virtual guide will be sent to labs centers by e-mail for construction.
- Surgical Procedures: The Principal investigator (DA) will extract the remaining root or tooth in an atraumatic procedure procedure using lancet, periotome, minimal force and rotational movement. After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement. In the test group, the computer guided surgical guide will be used for implant drilling and placement following the manufacturer's instructions. While in the control group, after tooth or root extraction implants will be placed free hand guided by the extraction sockets. Then in implants with primary stability (Insertion torque> 35 Ncm2), the final abutment will be placed and any further adjustment would be done immediately in the lab and re-positioned in place. The principal investigator (DA) will check the vacuum stent is in its place again intraorally, then a chair side tooth colored auto-polymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown. If any subject is to feel any movement in his/her temporary crown, an immediate phone call is to be done to (DA) to examine the cause of mobility (whether it is the crown only or the implant itself).
- Postoperative Care: The principal investigator (DA) will manage postoperative complications. The principal investigator (DA) will remove mobile temporary crowns and recement them. While mobile implants will be considered as early stage failed implants and it will be removed immediately. The patient will receive another implant at the same site after a proper healing period of at least 3 months during which he/she will be provided with a temporary removable partial denture for aesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer guided implant insertion group | Experimental | Device: Computer guided implant insertion groupAccording to the allocation, the experimental group will receive implants immediately placed in extraction sockets using CAD/CAM surgical guides. |
| Free hand implant insertion group | Active comparator | Device: Free hand implant insertion groupAccording to the allocation, the control group will receive implants immediately placed in extraction sockets using traditional free hand technique. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with hopeless teeth or remaining roots
- Bucco-lingual bone thickness of 7mm or more (Spray et al., 2000)
- Bucco-lingual keratinized mucosa of 6mm or more (Spray et al., 2000)
- Inter-arch space sufficient for prosthetic rehabilitation (7mm or more) (Misch, 2008)
- Adults more than 18 years old
Key exclusion criteria (3 listed)
- Uncontrolled diabetic patients (HbA1c value ≥ 8.1 percent) (Takeshita et al., 1998)(Javed \& Romanos, 2009)(Garg, 2010)(Retzepi \& Donos, 2010)(B R Chrcanovic et al., 2014)
- Heavy smokers (More than 10 cigarettes per day) (Nitzan et al., 2005) (Strietzel et al., 2007) (Abt, 2009)(Bruno Ramos Chrcanovic et al., 2015)
- Severe bruxers (Lobbezoo et al., 2006) (Manfredini et al., 2011)(Lin et al., 2012)(Zhou et al., 2015)
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 |
|---|---|---|
| Computer guided implant insertion groupImplants will be immediately inserted in fresh extraction sockets using CAD/CAM guides | Device | Computer guided implant insertion group |
| Free hand implant insertion groupImplants will be immediately inserted in fresh extraction sockets using free hand technique | Device | Free hand implant insertion group |
Primary outcome
Linear Deviation
Time frame: two months postoperative
The amount of linear deviation was measured through three parameters; global, lateral and depth deviation. These parameters will be measured at the apical and coronal center in a mesiodistal and buccolingual plane.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- BackgroundAlzoubi, 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), 391-398. http://doi.org/10.1002/smll.)) D'haese, J., Van De Velde, T., Komiyama, A., Hultin, M., & De Bruyn, H. (2012). Accuracy and complications using computer-designed stereolithographic surgical guides for oral rehabilitation by means of dental implants: a review of the literature. Clinical Implant Dentistry and Related Research, 14(3), 321-35. http://doi.org/10.1111/j.1708-8208.2010.00275.x Ortega-martínez, J., Pérez-pascual, T., Mareque-bueno, S., & Hernández-alfaro, F. (2012). Immediate implants following tooth extraction . A systematic review. Medicina Oral Patología Oral Y Cirugia Bucal- Oral Surgery Section, 17(2), e251-61. http://doi.org/10.4317/medoral.17469
- 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.
Maha ElKerdawy, Professor study chair
Professor at Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided implant insertion group and Free hand implant insertion group in people with Immediate Dental Implants, run by Cairo University.
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 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: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Mohammed Ayman, PhD (02001285463772, do3aa2@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear Deviation (time frame: two months postoperative). 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 NCT03281148, 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 13 Sep 2017.