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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tooth Loss; Dental Implants
• Intervention / Treatment: Procedure: Piezoelectric osteotomy.; Procedure: Conventional drilling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Almería, Spain, 04001
    • Recruiting
    • Isabel Godoy Reina
    • Contact: Isabel Godoy Reina; Phone Number: 661070242; Email: igodorei@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piezoelectric osteotomy; Implant placement by piezoelectric osteotomy	Procedure: Piezoelectric osteotomy.; Implants placed using the ultrasonic technique.
Active Comparator: Conventional drilling; Implant placement by conventional drilling	Procedure: Conventional drilling; Implants placed using drilling technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Loss	To compare MBL measured using radiographs.	1 month
Marginal Bone Loss	To compare MBL measured using radiographs.	3 months
Marginal Bone Loss	To compare MBL measured using radiographs.	6 months
Marginal Bone Loss	To compare MBL measured using radiographs.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary stability	Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.	Baseline
Secondary stability	Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.	3 months
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
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
Survival rate	To measure implant success rate.	3,6,12 months

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 1, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 1, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Dental implants; Piezoelectric osteotomy; Piezoelectric surgery; Immediate load
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: IGR UGranada

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No