Patient Satisfaction and Early Implant Failure of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Patient satisfaction
Study Overview
Brief Summary
Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediately, implants will be placed either by free hand or computer guided technique. patient satisfaction will be evaluated as primary outcome and early implant failure was evaluated as secondary outcome.
Detailed Description
General operative procedures:
Eligible patients will be randomized, at the surgical phase in two groups, study group (in which computer guided implant placement was done using computer aided surgical guide) and comparative group (in which free hand implant placement was done).
Patients of both groups will be subjected to:
Careful clinical examination and medical and dental history taking. CBCT scan will be performed while patients biting on cotton roll to separate the teeth of interest from opposing dentition, moreover cotton rolls will be placed in vestibule for separation of lip and check from teeth of interest.After examination of the CBCT scan, maxillary and mandibular alginate impression will be made for eligible patients.For temporary crown fabrication after the surgery, the tooth or root to be extracted will be modified on the study cast and an artificial tooth will be placed. After that a 2mm hard vacuum sheet will be pressed on the study cast. For the test group (computer guided group), three dimensional (3d) virtual planning of the surgical guide and implant position will be made with the aid of Blue Sky ® implant planning software . After proper selection of implant size, diameter and position, the virtual surgical guide will be exported as a STL file for 3D printing. Before the surgery, adaptation of the surgical guide will be checked on the study cast and a metallic sleeve will be attached at proposed implant position using adhesive.
Intraoperative procedure:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to the nature of the trial only the outcome assessor will be masked from the intervention or control group
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with teeth or remaining roots in the esthetic zone and indicated for extraction and replacement with immediate implant.
- •Sufficient labial bone to avoid labial plate fracture during extraction (at least 1.5-2 mm). This will be confirmed by cone beam computer tomography (CBCT) scan.
- •Sufficient mesio distal length between the neighbouring natural teeth (at least 7 mm), this will be confirmed on the study cast.
- •Presence of adjacent teeth to the tooth or remaining root to be extracted.
Exclusion Criteria
- •Heavy smokers (more than 2 packs / day). Patients with parafunctional habits (e.g. clenching or bruxism, etc.) Presence of acute infection in the tooth or the remaining root that will be extracted.
- •Severe overeruption of the opposing teeth to avoid premature contact with the temporary crown during the healing period.
- •Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with implant placement and its osseointegration (as uncontrolled diabetes, chemotherapy, radiotherapy. Osteonecrosis...)
Arms & Interventions
Computer guided immediate implant placement
For the test group, the computer aided surgical guide will be used for implant drilling and placement.
Intervention: Computer guided implant placement (Procedure)
Free hand immediate implant placement
For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls.
Intervention: Computer guided implant placement (Procedure)
Outcomes
Primary Outcomes
Patient satisfaction
Time Frame: 0-6 months
Patient satisfaction will be assessed through a questionnaire and each question of the questionnaire will be scored by the patients on 10 cm visual analogue scales (VAS)
Secondary Outcomes
- Early implant failure(0-6 months)
Investigators
Safaa Kamel Hussein
Assisstant Lecturer- Prosthodontic Department- Faculty of Dentistry- Principle Investigator
Cairo University