Clinical trial NCT04497571: Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone.
Official title: Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implants
Tooth Loss
Keywords: Dental implants
Piezoelectric osteotomy
Piezoelectric surgery
Immediate load
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trials.
Primary purpose: TREATMENT

Brief summary: Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.

Detailed description: Main goals.

Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.

Specific goals.

* Evaluate the marginal peri-implant bone loss after the healing period through radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year after the implants insertion.
* Evaluate the primary stability of each individual implant the day of their insertion to verify their load on the moment of surgery and also compare the values of each preparation techniques of implant bone preparation.
* Evaluate the secondary stability of each individual implant and compare the values of each preparation techniques.
* Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.

Eligibility criteria: Inclusion Criteria:

* Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar.
* 3 months after the dental extraction without alveolar scar tissue remains.
* Bone availability of at least 5mm of width and 13mm of length.
* At least 2 to 3 mm of soft tissue for the establishment of an adequate peri-implant biological width.
* Oclusal pattern that ensures prosthetic success.
* Implants need to have at least a 35 N and 70 ISQ index to be loaded.
* Index of plaque \< 20% and/or inactive periodontal disease.

Exclusion Criteria:

* Acute myocardial infarction in the last 2 months.
* Uncontrolled coagulation disorders
* Uncontrolled diabetes (HbA1c\> 7.5%).
* Radiotherapy on head/neck in the last 24 months.
* Immunocompromised patient.
* History of medication related to osteonecrosis of the jaws.
* Psychiatric disorders, alcohol, drugs and large smokers (\>10 cigarrillos).
* Plaque index \> 20%.
* Need for simultaneous or previous peri-implant guided bone regeneration procedures.

Primary outcomes:
measure: Marginal Bone Loss
timeFrame: 1 month
measure: Marginal Bone Loss
timeFrame: 3 months
measure: Marginal Bone Loss
timeFrame: 6 months
measure: Marginal Bone Loss
timeFrame: 12 months
Secondary outcomes:
measure: Primary stability
timeFrame: Baseline
measure: Secondary stability
timeFrame: 3 months
measure: Probing depth
timeFrame: 3,6,12 months
measure: Bleeding of probing
timeFrame: 3,6,12 months
measure: Survival rate
timeFrame: 3,6,12 months
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Isabel Godoy Reina
Study officials:
References: