Clinical trial NCT03720236: Peri-implant Tissues in BLX® Implants
Official title: Behavior of Peri-implant Tissues in BLX® Implants Placed on Mature Scarred Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failed
Dental Prosthesis Failure
Keywords: dental implant
immediate loading
periimplant tissues
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Manohay Dental SAU
First posted: 2018-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary stability of implants and peri-implant tissues
timeFrame: 12 months
Secondary outcomes:
measure: Basal Peri-implant tissue level: implant stability
timeFrame: 1 day
measure: Basal Radiological Bone Implant level
timeFrame: 1 day
measure: Basal Peri-implant tissue level: probing depth
timeFrame: 1 day
measure: Radiological bone implant stability
timeFrame: 6 weeks
measure: Peri-implant tissue stability: probing depth
timeFrame: 6 weeks
measure: Peri-implant tissue stability: ISQ
timeFrame: 6 weeks
measure: Clinical tissue levels of definitive prostheses: probing depth
timeFrame: 6 months
measure: Clinical tissue levels of definitive prostheses: ISQ
timeFrame: 6 months
measure: Radiological tissue levels of definitive prostheses: bone implant level
timeFrame: 6 months
Other outcomes:
measure: Long-term evaluation of definitive prostheses
timeFrame: 12 months
Locations:
city: Santiago De Compostela
country: Spain
facility: Mario Pérez Sayáns
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Mario Perez Sayans, PhD
role: PRINCIPAL_INVESTIGATOR
References: