Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02416700
Other study ID # Mpigozzo
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT03997578 - Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects N/A
Completed NCT02369562 - A Retrospective Analysis of Failures of Oral Implants
Completed NCT02374216 - A Prospective Analysis of Failures of Oral Implants N/A
Completed NCT02218515 - Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft Phase 4
Completed NCT05631600 - Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study Phase 2/Phase 3
Completed NCT03715374 - Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects N/A
Completed NCT04160689 - Influence of the Implant Connection on Facial Tissues Maturation Phase 4
Recruiting NCT05533528 - Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment N/A
Completed NCT03227367 - Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials. N/A
Not yet recruiting NCT04274244 - Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% and Enamel Matrix Derivative in Periodontal Regeneration. Phase 4
Recruiting NCT05766878 - The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics N/A
Recruiting NCT03978962 - Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
Completed NCT04043754 - Platelet-rich Fibrin and Autogenous Bone vs Membrane and Autogenous Bone in Intrabony Defects N/A
Recruiting NCT06318247 - Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets N/A
Active, not recruiting NCT00519155 - Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery Phase 2
Active, not recruiting NCT03510780 - Platelet-rich Fibrin and Autogenous Bone vs Enamel Matrix Derivative and Autogenous Bone in Intrabony Defects N/A
Enrolling by invitation NCT05932017 - Comparison of Gingival Flap Procedure Using Conventional Surgical Loupes vs. Videoscope for Visualization
Completed NCT05360511 - Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects Early Phase 1
Completed NCT04827693 - The Cortical Shield for Facial Bone Reconstruction
Completed NCT05170932 - The Use of Chlorhexidine Gel Following EDTA Root Surface Etching as an Adjunctive to Open Flap Debridement in Treating Intra-Bony Defects N/A