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Accuracy in Computer Guided Versus Free Hand Immediate Implantation (RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281148
Recruitment Status : Unknown
Verified September 2017 by Doaa Mohammed Ayman, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Doaa Mohammed Ayman, Cairo University

Brief 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. Accuracy of inserted implants will be measured.

Condition or disease Intervention/treatment Phase
Immediate Dental Implants Device: Computer guided implant insertion group Device: Free hand implant insertion group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Accuracy in Computer Guided Versus Free Hand Immediate Implant Placement in Fresh Extraction Sockets: a Randomized Controlled Clinical Trial
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Computer guided implant insertion group
According to the allocation, the experimental group will receive implants immediately placed in extraction sockets using CAD/CAM surgical guides.
Device: Computer guided implant insertion group
Implants will be immediately inserted in fresh extraction sockets using CAD/CAM guides

Active Comparator: Free hand implant insertion group
According to the allocation, the control group will receive implants immediately placed in extraction sockets using traditional free hand technique.
Device: Free hand implant insertion group
Implants will be immediately inserted in fresh extraction sockets using free hand technique




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with hopeless teeth or remaining roots
  2. Bucco-lingual bone thickness of 7mm or more (Spray et al., 2000)
  3. Bucco-lingual keratinized mucosa of 6mm or more (Spray et al., 2000)
  4. Inter-arch space sufficient for prosthetic rehabilitation (7mm or more) (Misch, 2008)
  5. Adults more than 18 years old

Exclusion Criteria:

  1. 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)
  2. Heavy smokers (More than 10 cigarettes per day) (Nitzan et al., 2005) (Strietzel et al., 2007) (Abt, 2009)(Bruno Ramos Chrcanovic et al., 2015)
  3. Severe bruxers (Lobbezoo et al., 2006) (Manfredini et al., 2011)(Lin et al., 2012)(Zhou et al., 2015)

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): NCT03281148


Contacts
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Contact: Doaa Mohammed Ayman, PhD 02001285463772 do3aa2@live.com
Contact: Doaa Ayman, PhD 02001285463772 doaa.auf@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Maha ElKerdawy, Professor Professor at Faculty of Dentistry
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

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Responsible Party: Doaa Mohammed Ayman, Assistant lecturer at Prosthodontic Department Faculty of Dentistry, Cairo University
ClinicalTrials.gov Identifier: NCT03281148    
Other Study ID Numbers: Prosthetic department
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 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 Doaa Mohammed Ayman, Cairo University:
immediate implants, accuracy,extraction sockets