Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)

Study Overview
=================
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 months post-prosthetic loading.

Official Title
-----------------
Behavior of the Peri-implant Tissues on the Multiposition Abutment Straight Aesthetic Slim Anti-rotational Galimplant

Conditions
-----------------
Dental Implant Failed, Dental Prosthesis Failure

Intervention / Treatment
-----------------
* Procedure: Straight abutment
* Procedure: Slim abutment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>The control group is considered, using the company's classic multi-position straight anti-rotational abutment | Procedure: Straight abutment<br>* This is the classic abutment, straight and anti-rotational for dental implants which have been tested before<br>|
| Experimental: Test group<br>The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used | Procedure: Slim abutment<br>* This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary stability of implants and peri-implant tissues | Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. Investigators will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal Peri-implant tissue level: implant stability | Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. We will load the crowns 8 weeks after implant surgery. Investigators will evaluate the stability at different moments, 8 weeks, 6 months and 12 months. The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ. ISQ values are obtained using resonance frequency analysis (RFA). | 1 day | 
| Basal Radiological Bone Implant level | At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements. | 1 day | 
| Basal Peri-implant tissue level: probing depth | At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements. | 1 day | 
| Radiological bone implant stability | After the implantation, we´ll load the temporary 8 weeks after the implantation. Investigators will evaluate the bone level stability at 6 weeks in both groups, through a dental X-ray radiography. The bone stability will be measured as a difference between de basal bone level and the actual one in mm. | 8 weeks | 
| Peri-implant tissue stability: probing depth | After the implantation, we´ll load the definitive prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the probing depth or just in case, the recession of the gingival margin. The stability will be given by the differences between both measures, basal and actual in mm. | 8 weeks | 
| Peri-implant tissue stability: ISQ | After the implantation, we´ll load the temporary prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be given by the differences between both measures, basal and actual. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implant, periimplant tissues