Evaluation of Peri Implant Bone Loss of Immediately Versus Conventionally Loaded Implants With a Single Prosthesis

Periodontal Bone Loss Clinical Trial

— Mpigozzo  

Official title:

Evaluation of Peri Implant Bone Loss of Immediately Loaded Versus Conventionally Loaded Implants With a Single Prosthesis: A Randomized and Clinical Study Split-mouth Experimental Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416700
• Other study ID #: Mpigozzo
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: March 2018

Study information

• Verified date: April 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this prospective, controlled, and randomized clinical study is to evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded implants with a single prosthesis. A split-mouth experimental design will be used, and the success rate of the installed implants will be determined. Twelve selected patients (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental implants. The protocol for preparing the surgical sites will be based on the manufacturer's recommendations and bone density. Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes, indicating which site is the test site, will be opened after the implants are installed. Transfer impressions of the implants receiving immediate loading will be produced so that temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal adjustment will be made to ensure minimal contact at maximum intercuspation and absence of contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of implant installation) and 3, 6, 9, and 12 months after implant installation, the following aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility of the implant, crestal bone loss around the implant (as determined by x-ray evaluation), probing depth around the implant, and periodontal pain.

Description:

The main objective of this prospective, controlled, and randomized clinical study is to evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded implants with a single prosthesis. A split-mouth experimental design will be used, and the success rate of the installed implants will be determined. Twelve selected patients (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental implants. The protocol for preparing the surgical sites will be based on the manufacturer's recommendations and bone density. Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes, indicating which site is the test site, will be opened after the implants are installed. Transfer impressions of the implants receiving immediate loading will be produced so that temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal adjustment will be made to ensure minimal contact at maximum intercuspation and absence of contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of implant installation) and 3, 6, 9, and 12 months after implant installation, the following aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility of the implant, crestal bone loss around the implant (as determined by x-ray evaluation), probing depth around the implant, and periodontal pain. These data will be collected for both the control/delayed loading group and the test/immediate loading group, followed by statistical analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria: edentulous sites bilateral in maxilla and mandibula with adequate quantity of bone

Exclusion Criteria: Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Bone Loss

Intervention

Procedure:
• immediate implant surgery
Surgery of dental implants in one side of the mouth.

Device:
• implant surgery (Straumann®)
Dental implant surgery in one of the sides of the mouth

Locations

Country	Name	City	State
Brazil	Mônica Nogueira Pigozzo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Mônica Nogueira Pigozzo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Cannizzaro G, Felice P, Leone M, Ferri V, Viola P, Esposito M. Immediate versus early loading of 6.5 mm-long flapless-placed single implants: a 4-year after loading report of a split-mouth randomised controlled trial. Eur J Oral Implantol. 2012 Summer;5(2):111-21. — View Citation

Galindo-Moreno P, León-Cano A, Ortega-Oller I, Monje A, O Valle F, Catena A. Marginal bone loss as success criterion in implant dentistry: beyond 2 mm. Clin Oral Implants Res. 2015 Apr;26(4):e28-e34. doi: 10.1111/clr.12324. Epub 2014 Jan 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Loss of Immediate Versus Conventional Implants as determined by x-ray evaluation	The same bone loss of for conventional and immediate implants.	12 months
Secondary	The success rate of the installed implants will be determined	Survival rate must be the same for the immediate and conventional implants	12 months

External Links

•   Galindo-Moreno P, León-Cano A, Ortega-Oller I, Monje A, O Valle F, Catena A. Marginal bone loss as success criterion in implant dentistry: beyond 2 mm.