NCT03287934

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 digital light processed guides for control group or selective laser sintering group for intervention group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

September 14, 2017

Last Update Submit

July 24, 2020

Conditions

Immediate Dental Implants

Keywords

selective laser sintering, digital light processing stents

Outcome Measures

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

    1 week

Study Arms (2)

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.

Device: selective laser sintered stentDevice: 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.

Device: selective laser sintered stentDevice: digital light processing(dlp)

Interventions

selective laser sintered stentDEVICE

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 )
digital light processing stentselective laser sintering
digital light processing(dlp)DEVICE

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)
digital light processing stentselective laser sintering

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • heavy smoking
  • any systemic condition that is considered absolute contraindication for implant placement
  • pregnancy
  • in adequate inter-arch space
  • parafunctional habits as bruxism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Manil, 02, Egypt

Location

Related Publications (1)

  • 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.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
due to the nature of study only the participants could be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 19, 2017

Study Start

December 1, 2017

Primary Completion

January 1, 2020

Study Completion

February 11, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)