Bone Healing at Non-submerged Implants Installed With Different Insertion Torques. A Split Mouth Histomorphometric Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Sponsor
- ARDEC Academy
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- New bone in contact with the implant surface
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of the study is to evaluate histomorphometrically the healing at implants installed with standard or very low insertion torque values.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
New bone in contact with the implant surface
Time Frame: After 8 weeks of healing
The percentages of new bone will be evaluated both in contact with the implant surface
Secondary Outcomes
- Bone density around the implant surface(After 8 weeks of healing)