Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients

Study Overview
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Brief Summary
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The objective of this study is to assess clinically the peri implant tissues, the radiological marginal bone loss and the stability around implants placed at the crestal versus the subcrestal level in type 2 controlled diabetic patients using cone beam computed tomography

Official Title
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Evaluation of Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients (Randomized Clinical Trial)

Conditions
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Dental Implant, Diabetes

Intervention / Treatment
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* Procedure: Implants placed at bone crest
* Procedure: Implants placed 1mm Subcrestally


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Type 2 controlled diabetic patients Patients with at least one missing tooth in lower jaw. Patients with sufficient alveolar ridge height and width (no need for bone augmentation). Patients with sufficient inter-occlusal distance that will allow future restoration. Patients with healthy periodontium. Exclusion criteria Smokers. Para functional habits. Bad oral hygiene measured according to O'Leary plaque index. Pregnant women. Other local or systemic diseases that may compromise the surgical procedure, healing or osteointegration.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crestally positioned implants<br> | Procedure: Implants placed at bone crest<br>* Mid crestal incision will be performed and full-thickness envelope flap will be elevated to expose the alveolar ridge (no releasing incisions will be made). Implant site will be prepared according to the manufacturer's instructions under sterile copious irrigation Implants will be placed at crestal level<br>|
| Active Comparator: Subcrestally positioned implants<br> | Procedure: Implants placed 1mm Subcrestally<br>* Implants will be placed 1mm subcrestally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Implant stability | Implant stability will be measured again by Osstell at 3 different directions (buccal, mesial and distal) at the time of implant loading (after 3 months from implant placement). | at baseline and 3 months | 
| change in margianl bone level | CBCT will be done Marginal bone loss in all aspects (mesial, distal buccal and lingual) The difference in distance from bone crest to apical end of the implant will be assessed at each follow up period then the mean will be calculated for mesial and distal and also for buccal and lingual. | at baseline, 3rd and 6th months |