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Peri-implant Tissues in BLX® Implants

U

University of Santiago de Compostela

Status

Completed

Conditions

Dental Implant Failed
Dental Prosthesis Failure

Treatments

Procedure: Implant loading
Procedure: Implant bed preparation protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT03720236
CT-2018-05

Details and patient eligibility

About

This is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in BLX implants loaded early or delayed and with different surgical milling protocols. To this end, 40 BLX implants with a diameter of 3.75x10 will be placed in areas of mature bone scarred after extraction. They will be divided into 2 study groups, and these in turn into two subgroups. Group A: complete milling, Group B: partial milling. Each group will be assigned with code 1: early load and code 2: deferred load. Clinical and radiological parameters will be evaluated.

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients without systemic pathology
  • Adult of age who agree to be part of the study and sign the informed consent.
  • Patients smoking less than 5 cigarettes / day,
  • Patients not being completely edentulous
  • Unitary / multiple absences in the area posterior with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques
  • Area of mature bone healed at least 6 months post-extraction.
  • The minimum torque for early loading will be 25 N. The placement of the implant will be mechanical up to 40 N maximum and manually finished with a surgical dynamometer.
  • The placement of the abutment will be at a minimum of 25 N, in case the primary stability of the implant allows it, it will be placed at 35 N.
  • The placement of the implant must always be 4 mm below the future gingival margi

Exclusion criteria

  • Immunosuppressed patients
  • Aesthetic edentulous areas of 13-23 and 33-43
  • Smokers of more than 5 cigarettes
  • Implants with a lower torque whose will be submerged with a screw and a protocol will be followed in 2 phases, being discarded from the study.
  • Index of bleeding greater than 30%
  • Patients with less than 2 mm of keratinized gingiva
  • Implants with ISQ index <55
  • When a margin of 1 mm safety cannot be assumed to the inferior dental nerve

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 4 patient groups

Full preparation
Experimental group
Description:
Group A: the complete milling protocol indicated by the manufacturer for the 3.75x10 mm BLX implant will be performed.
Treatment:
Procedure: Implant bed preparation protocol
Partial preparation
Experimental group
Description:
Group B: the partial / under milling protocol for the 3.75x10 mm implant, indicated by the manufacturer, will be carried out.
Treatment:
Procedure: Implant bed preparation protocol
Deferred loading
Experimental group
Description:
Code 2: for implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. Impressions will be taken at 6 weeks to place the provisional prosthesis at 8 weeks. At 6 months the final impressions will be taken for the definitive load.
Treatment:
Procedure: Implant loading
Immediate load
Experimental group
Description:
The code 1: to the implants with this random code, the prosthetic prosthesis SRA of 2.5 mm and its corresponding healing plug of 5.1 mm will be placed. The impression will be made in the same surgery and the placement of the provisional prosthesis before 7 days. At 6 months the final impressions will be taken for the definitive load.
Treatment:
Procedure: Implant loading

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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