Clinical trial NCT04017156: Bone Healing at Non-submerged Implants Installed With Different Insertion Torques.
Official title: Bone Healing at Non-submerged Implants Installed With Different Insertion Torques. A Split Mouth Histomorphometric Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Lead sponsor: ARDEC Academy
Sponsor class: NETWORK
First posted: 2019-07-12
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: New bone in contact with the implant surface
timeFrame: After 8 weeks of healing
Secondary outcomes:
measure: Bone density around the implant surface
timeFrame: After 8 weeks of healing
Other outcomes:
measure: pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue)
timeFrame: After 8 weeks of healing
Locations:
city: Cartagena de Indias
country: Colombia
facility: Colombia
state: Cartagena
Study officials:
References:
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