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

ARDEC Academy

Status: Completed

Conditions: Edentulous; Alveolar Process, Atrophy

Treatments: Procedure: implant installation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04017156

protocol #04-2014

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Test site (torque of <10 Ncm)

Experimental group

Description:

The test sites (\<10 Ncm) will be over-prepared with drills of larger diameter

Treatment:

Procedure: implant installation

Control site (torque of ~30 Ncm)

Other group

Description:

the standard sites (\~30 Ncm)will be prepared with the corresponding drills suggested by the manufacturer

Treatment:

Procedure: implant installation