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Clinical Trials/NCT03281148
NCT03281148UnknownNot Applicable

Evaluation of Accuracy in Computer Guided Versus Free Hand Immediate Implant Placement in Fresh Extraction Sockets: a Randomized Controlled Clinical Trial

Cairo University0 sites20 target enrollmentStarted: November 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Primary Endpoint
Linear Deviation

Study Overview

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.

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. 2. Dental history:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Arms & Interventions

Computer guided implant insertion group

Experimental

According to the allocation, the experimental group will receive implants immediately placed in extraction sockets using CAD/CAM surgical guides.

Intervention: Computer guided implant insertion group (Device)

Free hand implant insertion group

Active Comparator

According to the allocation, the control group will receive implants immediately placed in extraction sockets using traditional free hand technique.

Intervention: Free hand implant insertion group (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Doaa Mohammed Ayman

Assistant lecturer at Prosthodontic Department Faculty of Dentistry

Cairo University

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