Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone.

Dental Implants Clinical Trial

Official title:

Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497571
• Other study ID #: IGR UGranada
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: August 2020
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implants
• Tooth Loss

Intervention

Procedure:
• Piezoelectric osteotomy.
Implants placed using the ultrasonic technique.
• Conventional drilling
Implants placed using drilling technique

Locations

Country	Name	City	State
Spain	Isabel Godoy Reina	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Bone Loss	To compare MBL measured using radiographs.	1 month
Primary	Marginal Bone Loss	To compare MBL measured using radiographs.	3 months
Primary	Marginal Bone Loss	To compare MBL measured using radiographs.	6 months
Primary	Marginal Bone Loss	To compare MBL measured using radiographs.	12 months
Secondary	Primary stability	Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.	Baseline
Secondary	Secondary stability	Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.	3 months
Secondary	Probing depth	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.	3,6,12 months
Secondary	Bleeding of probing	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.	3,6,12 months
Secondary	Survival rate	To measure implant success rate.	3,6,12 months