Bone Healing at Non-submerged Implants Installed With Different Insertion Torques.

Study Overview
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Brief Summary
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The objective of the study is to evaluate histomorphometrically the healing at implants installed with standard or very low insertion torque values.

Detailed Description
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Very high insertion torque values have been recommended when immediate loading is applied to implants.1 However, it has been shown that similar clinical outcomes may be achieved even with insertion torque values ≤15 Ncm when implants are splinted together. Due to the contradictory outcomes on the influence of the torque on osseointegration and a lack of histological data in humans, there is a need of more evidences that may support the clinicians in the decision making when an unintentional low insertion torque occur at implants during the daily practice. So the aim of the study i evaluate histomorphometrically the healing at implants installed in Twelve volunteer patients that will be recruited. Two screw-shaped titanium devices will be installed in the distal segments of the mandible using insertion torque values of either <10 Ncm or  30 Ncm. The implants were left to heal in a non-submerged fashion. After 8 weeks, biopsies will be retrieved and ground sections will be prepared for histological evaluation.

Official Title
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Bone Healing at Non-submerged Implants Installed With Different Insertion Torques. A Split Mouth Histomorphometric Randomized Controlled Trial.

Conditions
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Edentulous; Alveolar Process, Atrophy

Intervention / Treatment
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* Procedure: implant installation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of at least two edentulous zone in the posterior segment of the mandible ≥ 25 years of age smoking ≤ 10 cigarettes per day Good general health No contraindication for oral surgical procedures. Not being pregnant. Exclusion Criteria: Presence of systemic disorders Chemotherapy or radiotherapy; Smokers >10 cigarettes per day Previous bone augmentation procedures in the region

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 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
Interventional Model Description: Clinical Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test site (torque of <10 Ncm)<br>The test sites (<10 Ncm) will be over-prepared with drills of larger diameter | Procedure: implant installation<br>* All site preparations will be performed deeper compared to the length of the implant so that the implant apex cannot reach the bottom of the osteotomy.<br>* Other names: implant surgery;|
| Other: Control site (torque of  30 Ncm)<br>the standard sites ( 30 Ncm)will be prepared with the corresponding drills suggested by the manufacturer | Procedure: implant installation<br>* All site preparations will be performed deeper compared to the length of the implant so that the implant apex cannot reach the bottom of the osteotomy.<br>* Other names: implant surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New bone in contact with the implant surface | The percentages of new bone will be evaluated both in contact with the implant surface | After 8 weeks of healing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density around the implant surface | The total mineralized bone will be assessed as sum of new and old bone | After 8 weeks of healing |