Immediate Functional Versus Non Functional Implant Loading in the Mandible

Study Overview
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Brief Summary
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comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT).

Detailed Description
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Patients are more demanding after the revolution in immediate implant dentistry which reduces implant procedure nowadays according to literature and research. In response to patients' demands not only implants are immediately placed but also immediately loaded within 72 hours reducing the time for prosthetic loading and also improving bone formation according to some studies. The debate in modern implant dentistry is whether to immediately load the implants in functional occlusion or non-functional occlusion and which will improve the osseointegration and reduce crestal bone loss. Implants of the BioInfinity system were placed in 16 subjects divided into two groups. Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with immediate functionally loaded implants. Group (B): 8 patients with missing posterior mandibular teeth in whom immediate non-functionally loaded implants were used. The two groups were evaluated at baseline, immediately after implant placement and 4 months postoperative to evaluate crestal bone level and quantitative radiographic bone density using CBCT.

Official Title
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A Comparative Study Between Immediate Functional and Non-functional Loading of Dental Implants in the Posterior Alveolar Mandibular Region (a Randomized Clinical Trial)

Conditions
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Dental Implants, Edentulous Alveolar Ridge

Intervention / Treatment
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* Other: immediate functional implant loading
* Other: immediate non functional implant loading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged (20-40) years old. Missing Posterior tooth or teeth indicated for implant placement. Residual alveolar ridge at least 10 mm high and at least 4 mm wide. Exclusion Criteria: Systemic diseases that will contraindicate the surgery. Poor Oral Hygiene. The patient refuses to undergo the surgery. Parafunctional habits.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: immediate functional loading with temporary crowns<br>patients were rehabilitated with immediate functionally loaded implants. | Other: immediate functional implant loading<br>* Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.<br>|
| Experimental: immediate non functional loading with temporary crowns<br>patients were rehabilitated with immediate non-functionally loaded implants. | Other: immediate non functional implant loading<br>* implant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Visual analogue scale consist of a scale of 10 0 means no pain 10 menas pain is as bad as it could possibly be | immediately Postoperatively | 
| Change in crestal bone loss | CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss | immediately Postoperatively and after 4 months |