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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Doaa Mohammed Ayman, PhD contact

02001285463772

do3aa2@live.com

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.

  1. Case history
  2. 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.
  3. Dental history: The principal investigator (DA) will ask all patients about past dental procedures including implants.
  4. Clinical examination <!-- -->
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Virtual planning and construction of surgical guide
  10. 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.
  11. 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).
  12. 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.
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 groups in NCT03281148
Study groupRoleWhat they receive
Computer guided implant insertion groupExperimentalAccording 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 groupActive comparatorAccording 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.

  1. 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.

  1. First posted13 Sep 2017
  2. Study startNov 2017 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

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)
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

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.

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