NCT04017156

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: ARDEC Academy · Network
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Edentulous; Alveolar Process, Atrophy

Interventions

Type	Name	Description
PROCEDURE	implant installation	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.

Timeline

• Start date: 2016-07-20
• Primary completion: 2016-11-22
• Completion: 2017-10-17
• First posted: 2019-07-12
• Last updated: 2019-07-12

Locations

1 site across 1 country: Colombia