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CompletedNCT03287934RCTUpdated Jul 28, 2020

Accuracy of Selective Laser Sinteredcomputer Guided Stents Versus Digital Light Processing Stents

An interventional study of selective laser sintered stent and digital light processing(dlp) in Immediate Dental Implants, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Immediate Dental Implants

Keywords

  • selective laser sintering, digital light processing stents
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    digital light processing stent

    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.

    Device: selective laser sintered stent · Device: digital light processing(dlp)

  • Active comparator
    selective laser sintering

    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.

    Device: selective laser sintered stent · Device: digital light processing(dlp)

Interventions

  • Deviceselective 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.

    Also known as: Mega selective laser sintering (brand name )

  • Devicedigital light processing(dlp)

    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.

    Also known as: mogassam (brand name)

05

What researchers measure

Primary outcomes

  1. evaluation of accuracy of implant placement clinical observation

    measuring both angular and linear deviation of implants by virtual ruler in terms of mm

    Time frame: 1 week

06

Study locations

1 site
  • Faculty of Dentistry Cairo University
    Cairo, Manil 02, Egypt
07

References and documents

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.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03287934
Lead sponsor
Cairo University
Responsible party
mahetab hamdi (principal investigator, Cairo University) — Principal investigator
First posted
Sep 19, 2017
Start date
Dec 1, 2017
Primary completion
Jan 1, 2020
Completion
Feb 11, 2020
Last update
Jul 28, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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