Clinical trial NCT03796494: Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)
Official title: Behavior of the Peri-implant Tissues on the Multiposition Abutment Straight Aesthetic Slim Anti-rotational Galimplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failed
Dental Prosthesis Failure
Keywords: dental implant
periimplant tissues
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Galimplant Dental Implants
First posted: 2019-01-08
Enrollment: 80
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, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery. To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12-24 months post-prosthetic loading.


Eligibility criteria: Inclusion Criteria:

* Patients without systemic pathology that are grounds for absolute contraindication
* Older adults who agree to be part of the study and sign the informed consent
* Consumption of tobacco less than 5 cigarettes / day
* Do not be completely toothless
* Absences of at least two pieces in posterior area with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques. In case of odd absences (3,5,7), a Slim pillar will be placed, being the group to always be the majority.
* Area of mature bone healed at least 6 months post-extraction.
* Patients with a sufficient amount of bone to place implants 4 mm in diameter and 10 mm long

Exclusion Criteria:

* Immunosuppressed
* Aesthetic edentulous areas of 13-23 and 33-43
* Smokers of more than 5 cigarettes
* Index of bleeding greater than 30%
* Patients with less than 2 mm of keratinized gingiva
* Implants with primary stability with ISQ \<55
* Implants with ISQ index \<55 at 8 weeks
* When a margin of safety can not be assumed to the inferior dental nerve of at least 1 mm

Primary outcomes:
measure: Primary stability of implants and peri-implant tissues
timeFrame: 10 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: 8 weeks
measure: Peri-implant tissue stability: probing depth
timeFrame: 8 weeks
measure: Peri-implant tissue stability: ISQ
timeFrame: 8 weeks
Other outcomes:
measure: 6-months clinical evaluation of probing depth
timeFrame: 6 months
measure: 6-months ISQ evaluation
timeFrame: 6 months
measure: 6-months radiological evaluation of definitive prostheses
timeFrame: 6 months
measure: Long-term Radiological bone implant stability
timeFrame: 24 months
measure: Long-term Peri-implant tissue stability: ISQ
timeFrame: 24 months
measure: Long-term Peri-implant tissue stability: probing depth
timeFrame: 24 months
Locations:
city: Santiago De Compostela
country: Spain
facility: Mario Pérez Sayáns
state: A Coruña
Study officials:
References: