Clinical trial NCT04022265: Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills
Official title: Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: ARDEC Academy
Sponsor class: NETWORK
First posted: 2019-07-17
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
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 purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills.

Detailed description: Sixteen volunteer patients will be recruited. Two titanium mini-implants will be installed in the distal segments of the maxilla in recipient sites prepared with either a sonic device or conventional drills. Biopsies containing the mini-implants will be retrieved after 2 weeks in eight patients, and after 6 weeks in the other eight patients. Histomorphometric analyses will be performed

Eligibility criteria: Inclusion Criteria:

* presence of an edentulous atrophic zone in the posterior segment of the maxilla
* height of the sinus floor ≥10 mm
* ≥ 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 same region.

Primary outcomes:
measure: New bone in contact with the implant surface
timeFrame: After 2 weeks to evaluate the healing prior to load with a prosthesis
measure: New bone in contact with the implant surface
timeFrame: After 6 weeks, to evaluate the healing prior to load with a prosthesis
Secondary outcomes:
measure: The percentage of total mineralized bone in contact with the implant surface.
timeFrame: After 2 weeks to evaluate the healing prior to load with a prosthesis
measure: The percentage of total mineralized bone in contact with the implant surface.
timeFrame: After 6 weeks to evaluate the healing prior to load with a prosthesis
Other outcomes:
measure: pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels
timeFrame: After 2 weeks to evaluate the early haling prior to load with a prosthesis
measure: pre-existing (old) bone, soft tissues (marrow spaces, Haversian canals, BMUs canals), bone debris/ clot remnants, and vessels
timeFrame: After 6 weeks to evaluate the early haling prior to load with a prosthesis
Locations:
city: Cartagena de Indias
country: Colombia
facility: Colombia
state: Cartagena
Study officials:
References:
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