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

Dental Implant Failed Clinical Trial

— (PSG)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796494
• Other study ID #: CT-2019-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 8, 2020

Study information

• Verified date: March 2020
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 8, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failed
• Dental Prosthesis Failure
• Prosthesis Failure

Intervention

Procedure:
• Straight abutment
This is the classic abutment, straight and anti-rotational for dental implants which have been tested before
• Slim abutment
This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space

Locations

Country	Name	City	State
Spain	Mario Pérez Sayáns	Santiago De Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	Galimplant Dental Implants

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long-term evaluation of definitive prostheses	After 6 months of loading of final ceramic restoration, investigators will evaluate the differences of clinical (mm of probing depth, ISQ implant stability) and radiological aspects (bone implant level in mm calculated from the neck to the actual bone level, comparing on the basal and final values.	6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   GI-1319