Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)
- Conditions
- Dental Prosthesis FailureDental Implant Failed
- Interventions
- Procedure: Slim abutmentProcedure: Straight abutment
- Registration Number
- NCT03796494
- Lead Sponsor
- University of Santiago de Compostela
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group Slim abutment The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used Control Group Straight abutment The control group is considered, using the company's classic multi-position straight anti-rotational abutment
- Primary Outcome Measures
Name Time Method Primary stability of implants and peri-implant tissues 10 months 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
- Secondary Outcome Measures
Name Time Method Basal Peri-implant tissue level: implant stability 1 day 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, 12 months and 24 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).
Basal Radiological Bone Implant level 1 day 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.
Basal Peri-implant tissue level: probing depth 1 day 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.
Radiological bone implant stability 8 weeks 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.
Peri-implant tissue stability: probing depth 8 weeks 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.
Peri-implant tissue stability: ISQ 8 weeks 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.
Trial Locations
- Locations (1)
Mario Pérez Sayáns
🇪🇸Santiago De Compostela, A Coruña, Spain