Evaluation of Peri Implant Bone Loss of Immediately Versus Conventionally Loaded Implants With a Single Prosthesis
Mpigozzo
1 other identifier
interventional
17
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedApril 17, 2019
April 1, 2019
1.5 years
March 26, 2015
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The success rate of the installed implants will be determined
12 months
Study Arms (2)
immediate implant surgery
EXPERIMENTALImmediate implant surgery in one site.
conventional implant surgery
ACTIVE COMPARATORConventional implant surgery in another site
Interventions
Surgery of dental implants in one side of the mouth.
Dental implant surgery in one of the sides of the mouth
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mônica Nogueira Pigozzo
São Paulo, 04726-010, Brazil
Related Publications (2)
Galindo-Moreno P, Leon-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.
PMID: 24383987BACKGROUNDCannizzaro 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.
PMID: 22866288BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mônica N. Pigozzo, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Student
Study Record Dates
First Submitted
March 26, 2015
First Posted
April 15, 2015
Study Start
May 1, 2016
Primary Completion
November 1, 2017
Study Completion
March 1, 2018
Last Updated
April 17, 2019
Record last verified: 2019-04