Effect of Sodium Alendronate on the Final Implant Stability.

Study Overview
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Brief Summary
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evaluation of the final implant stability after its placement in sockets preserved with two different socket preservation materials

Detailed Description
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compare the stability of implant placement using Osstell ISQ resonance frequency analyzer, and marginal bone resorption and bone density around implant by X-ray analysis in different socket preservation techniques comparing sodium alendronate with the sticky bone graft technique

Official Title
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Effect of Sodium Alendronate Versus Sticky Bone as Socket Preservation Materials on the Final Implant Stability. A Randomized Clinical Trial

Conditions
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Anterior Labial Wall Defect

Intervention / Treatment
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* Procedure: Socket Preservation technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with seeking implant drive prosthesis after socket has been preserved by either technique. Patients with seeking implant drive prosthesis with Salama Class 3 defective sockets. Both genders males and females will be included. Exclusion Criteria: General contraindications to implant surgery. Patient seeking immediate implant placement. Subjected to irradiation in the head and neck area less than 1 year before implantation. Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised. Treated or under treatment with intravenous amino-bisphosphonates. Active infection or severe inflammation in the area intended for implant placement. Unable to open mouth sufficiently to accommodate the surgical tooling. Patients participating in other studies, if the present protocol could not be properly followed. Referred only for implant placement or unable to attend a 5-year follow-up

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: implant placement in defective Sockets preserved with alendronic acid sponge<br>anesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier. The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material. | Procedure: Socket Preservation technique<br>* Implant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama&salama Class 3 labial wall defect<br>* Other names: Implant in socket preserved with sodium alenderonate drug;|
| Active Comparator: Implant placement in Defective sockets preserved with sticky bone<br>anesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier. The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material. | Procedure: Socket Preservation technique<br>* Implant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama&salama Class 3 labial wall defect<br>* Other names: Implant in socket preserved with sodium alenderonate drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | Calculate the final implant stability of two groups using Osstell resonance frequency analyzer | 3-4 months after Dental implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marginal bone | Evaluation of marginal bone resorption around implant in two groups using superimposition x-ray (CBCT) software analysis | 3-4 months after Dental implant placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stability, Sodium Alendronate, Implant, Sticky bone