Dental Implants Clinical Trial
— BL-ImplantsOfficial title:
The Marginal Bone Loss in Implants of External Connection Versus Internal Connection and Submerged Implants Versus Non-submerged Implants
Verified date | September 2021 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
When an implant is placed, it is assumed that there will be a loss of bone in the more coronal area around it. The placement of the implant in relation to bone level, either crestal or subcrestal and the type of connection chosen, either external connection or internal connection, have been related as one of the factors that caused this loss. The preservation of the peri-implant bone influences the shape and contour of the underlying soft tissues, which are important for the aesthetic result of the treatment and for the success of the same. Hypothesis: The hypothesis is that there are no differences between the external and internal connection with regard to marginal bone loss. In implants placed at the crestal and subcrestal level, the hypothesis is that there is greater marginal bone loss in implants placed at the subcrestal level. Objectives: Main: To evaluate the marginal bone loss around implants of internal connection and external connection. Secondary: To compare the loss of bone in implants of internal connection placed at crestal and subcrestal level. To evaluate intra and post-operative complications. Material and methods: A prospective and randomized radiological study will be performed. 150 implants will be placed in patients who must present partial edentulism and require the replacement of at least 2 crowns on implants in the same jaw. In a randomized manner, implants of external connection and internal connection will be placed. Other features such as surface treatment type of the implant will be similar in both types of implants to reduce bias. With this study the investigators will try to define if there is a procedure in when to the connection of the implant and the location of this, that is more beneficial with respect to the preservation of bone.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | February 17, 2022 |
Est. primary completion date | January 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients of general age who present partial edentulism in the mandible and / or maxilla and require the replacement of at least 2 teeth by implants in the same maxilla. - The teeth must have been removed at least 4-6 months before implant placement. - The minimum required bone height would be 6mm, which would be determined by an orthopantomography (1: 1) Exclusion Criteria: - History of use of bisphosphonates - Evidence of serious systemic diseases such as recent infarction - Uncontrolled diabetes, coagulation disorders, cancer, psychiatric contraindications, - Active infection in the area of the implants - Absence of an antagonist in the area of implant placement - Pharmacological treatments capable of affecting gingival health - Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
Spain | Natalia Palacios Garzon | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari de Bellvitge |
Spain,
Galindo-Moreno P, Fernández-Jiménez A, O'Valle F, Monje A, Silvestre FJ, Juodzbalys G, Sánchez-Fernández E, Catena A. Influence of the crown-implant connection on the preservation of peri-implant bone: a retrospective multifactorial analysis. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):384-90. doi: 10.11607/jomi.3804. — View Citation
Peñarrocha-Diago MA, Flichy-Fernández AJ, Alonso-González R, Peñarrocha-Oltra D, Balaguer-Martínez J, Peñarrocha-Diago M. Influence of implant neck design and implant-abutment connection type on peri-implant health. Radiological study. Clin Oral Implants Res. 2013 Nov;24(11):1192-200. doi: 10.1111/j.1600-0501.2012.02562.x. Epub 2012 Aug 28. — View Citation
Pozzi A, Tallarico M, Moy PK. Three-year post-loading results of a randomised, controlled, split-mouth trial comparing implants with different prosthetic interfaces and design in partially posterior edentulous mandibles. Eur J Oral Implantol. 2014 Spring;7(1):47-61. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ANALYSIS OF THE RESONANCE FREQUENCY | Using the Penguin device, the investigators measure the coefficient of stability of the implant. Measurements will be made the day of implant placement, the day of placement of the healing abutment (two-three months after implant placement) and the day of delivery of the crown (3-4 months after placement Of the implant) | 4-5months around | |
Primary | A COMPARISON BETWEEN THE DIFFERENT CONNECTIONS AND POSITIONING OF THE IMPLANTS REGARDING THE BONE OF LOSS | By means of measurements in millimeters in the radiographs, the loss of bone will be compared. These measurements will be made one month after the placement of the implant, at 3-4 months in the placement of the crown, 6 months after placement of the crown and one year after placement of the crown | 1,4 years around |
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