Edentulous; Alveolar Process, Atrophy
Conditions
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.
Interventions
PROCEDUREimplant 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.
Sponsors
ARDEC Academy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The two recipient sites will be selected prior the surgery, while the type of site preparation will be randomly decided. The randomization will be performed electronically (randomization.com) by a researcher neither involved in the selection of the patients nor in installation of the devices (DB). Sealed opaque envelopes will be prepared and opened at the time of surgery by an author not involved in the surgery (DB). Surgeon and patients will be blinded.
Intervention model description
Clinical Trial
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue) | After 8 weeks of healing | The percentages of pre-existing (old) bone, soft tissue (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and marrow spaces (soft tissue) will be evaluated all in contact with the implant surface |
Countries
Colombia
Outcome results
None listed