Evaluation of Implant Stability in Low Quality Bone Following The Use of Osseodensifiers Versus Ridge Expanders

Study Overview
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Brief Summary
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the use of osseodensification technique compared to ridge expansion screws in low bone quality

Detailed Description
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using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone

Official Title
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Evaluation of the Stability of Implants Placed in Low Quality Bone Following The Use of Osseodensification Technique Versus Ridge Expanders: Randomized Clinical Trial

Conditions
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Low Bone Density

Intervention / Treatment
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* Procedure: Densah burs
* Procedure: Ridge expansion screws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Single tooth missing in the maxillary region with D3 (350-850 HU) and D4 (150-350 HU) bone (Sultana et al., 2020). A minimum of 4 mm residual buccolingual bone width at site of implant placement (Koutouzis et al., 2019). The recipient site of the implant should be free from any pathological conditions. No diagnosed bone disease or medication known to affect bone metabolism. Patients who are cooperative, motivated and hygiene conscious. Patients having adequate inter-occlusal space of 8-10 mm (Fernández et al., 2017) Exclusion Criteria: Systemic conditions/diseases that contraindicate surgery (Jarikian et al., 2021). Patients who have any habits that might jeopardize the osseointegration process, such as current smokers (Vollmer et al., 2020). Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching (Sultana et al., 2020). Alcohol or drug abuse (Ibrahim et al., 2020). Pregnant and lactating women.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osseodensification technique group<br>10 patients will be randomly assigned to the osseodensification group so the implant osteotomy will be prepared using densah burs | Procedure: Densah burs<br>* using Densah burs to prepare implant osteotomy<br>|
| Active Comparator: Ridge expansion screw group<br>10 patients will be randomly assigned to the ridge expansion screw group so the implant osteotomy will be prepared using ridge expansion screws | Procedure: Ridge expansion screws<br>* using Ridge expansion screws to prepare implant osteotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | assessing the stability using Osstell | change from baseline at 3 month | 
| Implant stability | assessing the stability using Osstell | change from baseline at 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic bone density | using CBCT in mm | change from baseline at 3 month | 
| Radiographic bone density | using CBCT in mm | change from baseline at 6 month | 
| Change in crestal bone level | using CBCT in mm | change from baseline at 3 month | 
| Change in crestal bone level | using CBCT in mm | change from baseline at 6 month | 
| Change in buccolingual bone width | using CBCT in mm | change from baseline at 3 month | 
| Change in buccolingual bone width | using CBCT in mm | change from baseline at 6 month | 
| Patient reported outcomes | 10 mm Visual analogue scale from 1 to 10 with 1 minimal pain and 10 worst pain experience | at time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osseodensification, ridge expansion screw