- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192461
Accuracy of Tooth Guided Immediate Implant Placement at Molar Region
Introduction: The concept of immediate implant placement has become popular due to reduced trauma and reduced overall treatment time. Removal of molar teeth provides a challenging and intriguing dilemma due to multiple root morphology. In cases of extraction and immediate placement of implants in the molar region, removal of the inter-radicular septum should be avoided to attain initial implant stability at the time of placement, and prevent slipping of the implant into the extraction socket. Following this technique prevents the slippage of the implant and allows the implant to be guided into the inter-radicular septum.
Objectives: To assess the accuracy of implant placement using the remaining roots of multi-radicular mandibular molars, evaluate bone density around implants and implant stability in fresh extracted site.
Materials and Methods: A prospective study was done on 10 patients with badly destructed mandibular molars. The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Alexandria, Egypt
- faculty of dentistry Alexandria university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Badly destructed mandibular molar teeth.
- Integrity of the roots.
- Bone coverage of 2/3 of the root.
- Sufficient bone volume.
- Adequate interocclusal distance >7mm.
- Adequate amount of keratinized mucosa.
- Age ranging from 20-45 years.
- Medically fit patients.
Exclusion Criteria:
- Unfavorable position of the tooth or remaining roots.
- Molars with Fused roots.
- Root ankylosis.
- Patients with systemic conditions known to affect the periodontal status and healing such as uncontrolled diabetes and osteoporosis.
- Patients receiving chemotherapy or radiotherapy.
- Heavy smokers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: tooth guided immediate implant placement group
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The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
implant stability quotient
Time Frame: 3 months
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implant stability quotient will be assessed using Osstell device.
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3 months
|
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Implant position accuracy using cone beam computed tomography
Time Frame: immediately
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Immediate postoperative and a preoperative conebeam CT will be done. The preoperative and postoperative scans will then be over¬lapped using a dedicated algorithm, which will allow the comparison of the virtually planned and the actual implant positions. Three deviation parameters between each planned and placed implant will be measured. All measurements will be performed using Mimics Innovation Suite 19 ™ software (Materialise Mimics software 3D Medical Imaging, Belgium). For analyzing the accuracy, the planned position of the implant will be compared with the actual position of the implant after insertion. Several measuring points will be measured:
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immediately
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Bone density around implant
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Samraa Elsheikh, PhD, Alexandria University
Publications and helpful links
General Publications
- Mahesh L, Kurtzman GM, Schwartz D, Shukla S. Residual Roots as an Anatomical Guide for Implant Placement: Case Series With Two-Year Follow-up. J Oral Implantol. 2016 Jun;42(3):285-8. doi: 10.1563/aaid-joi-D-15-00101. Epub 2015 Sep 21.
- Rodriguez-Tizcareno MH, Bravo-Flores C. Anatomically guided implant site preparation technique at molar sites. Implant Dent. 2009 Oct;18(5):393-401. doi: 10.1097/ID.0b013e3181b4b205.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Tooth guided immediate implant
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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