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

Not Applicable

Completed

• Conditions: Edentulous; Alveolar Process, Atrophy
• Interventions: Procedure: implant installation

• Registration Number: NCT04017156
• Lead Sponsor: ARDEC Academy

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.

Study Timeline

• Study Start: 2016-07-20
• Primary Completion: 2016-11-22
• Study Completion: 2017-10-17
• Status Verified: 2019-07
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-11
• Last Update Submitted: 2019-07-11
• Study First Posted: 2019-07-12
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control site (torque of ~30 Ncm)	implant installation	the standard sites (\~30 Ncm)will be prepared with the corresponding drills suggested by the manufacturer
Test site (torque of <10 Ncm)	implant installation	The test sites (\<10 Ncm) will be over-prepared with drills of larger diameter

Primary Outcome Measures

Name	Time	Method
New bone in contact with the implant surface	After 8 weeks of healing	The percentages of new bone will be evaluated both in contact with the implant surface

Secondary Outcome Measures

Name	Time	Method
Bone density around the implant surface	After 8 weeks of healing	The total mineralized bone will be assessed as sum of new and old bone

Trial Locations

Locations (1)

Colombia; 🇨🇴 Cartagena de Indias, Cartagena, Colombia