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Accuracy of Selective Laser Sintered Computer Guided Stents Versus Stereolithographic Stents (RCT)

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ClinicalTrials.gov Identifier: NCT03287934
Recruitment Status : Unknown
Verified September 2017 by mahetab hamdi, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
mahetab hamdi, Cairo University

Brief 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 stereolithographic guides for control group or selective laser sintering group for intervention group.

Condition or disease Intervention/treatment Phase
Immediate Dental Implants Device: selective laser sintered stent Device: stereolithographic stent Not Applicable

Detailed Description:

the principle investigator will randomize and equally distribute the Eligible patients between the selective laser sintering group (intervention group) and stereolithograhic stent 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 stereolithography 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: due to the nature of study only the participants could be blinded
Primary Purpose: Treatment
Official Title: Accuracy of Selective Laser Sintered Computer Guided Stents Versus Stereolithographic Stents in Immediate Implant Placement in Esthetic Zone, a Randomized Controlled Study
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: selective laser sintered stent
according to the allocation, the experimental group will receive a selective laser sintered stent for immediate implant drilling and placement after atraumatic extraction of the target tooth.
Device: selective laser sintered stent
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.
Other Name: Mega selective laser sintering (brand name )

Device: stereolithographic stent
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 stereolithographic 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.
Other Name: Evision tech e-shell 300 (brand name)

Active Comparator: stereolithographic stent
according to the allocation, the intervention for the control group will be a stereolithographic stent after atraumatic extraction of the target tooth for immediately implant placement. the stereolithographic stent will be adapted and drilling will be done through the stent.
Device: selective laser sintered stent
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.
Other Name: Mega selective laser sintering (brand name )

Device: stereolithographic stent
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 stereolithographic 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.
Other Name: Evision tech e-shell 300 (brand name)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. evaluation of soft tissue aspects around implant clinical observation [ Time Frame: 1 week ]
    evaluation of soft tissue aspect around implant by using pink esthetic score index( PES)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient age should be more than 18 years old
  2. Hopeless tooth in esthetic zone due to caries, endodontical problem or trauma with both neighboring teeth present.
  3. Good oral hygiene
  4. No periapical lesions (acute accesses or chronic fistula)
  5. Adequate bone (5 mm) below the tooth to allow primary implant stability
  6. Sufficient Medio-distal bone about 1.5 from each side
  7. sufficient labial bone
  8. sufficient band of keratinized mucosa

Exclusion Criteria:

  1. heavy smoking
  2. any systemic condition that is considered absolute contraindication for implant placement
  3. pregnancy
  4. in adequate inter-arch space
  5. parafunctional habits as bruxism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287934


Contacts
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Contact: mahetab H abd el fattah 01011035347 dream.ofimpossible@yahoo.com

Sponsors and Collaborators
Cairo University

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.

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Responsible Party: mahetab hamdi, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03287934    
Other Study ID Numbers: R.prosthodontic department
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by mahetab hamdi, Cairo University:
selective laser sintering, stereolithography stents