The Marginal Bone Loss in Dental Implants

NCT03232372 | Unknown DMC

• 1 other identifier: HUB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implants

Keywords

Bone loss, dental implant desing

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• ANALYSIS OF THE RESONANCE FREQUENCY

  4-5months around

Study Arms (3)

External-Connection non-submerged Imp

EXPERIMENTAL

We will place implants with external connection and non- submerged to assess the bone loss around

Device: External-Connection non-submerged Imp

Internal Connection Submerged implants

EXPERIMENTAL

We will place implants with internal connection and submerged to assess the bone loss around

Device: Internal Connection Submerged implants

Internal Connection non-Submerged Impl

EXPERIMENTAL

We will place Internal connection implant and non-Submerged Implants to assess the bone loss around

Device: Internal Connection non-Submerged Impl

Interventions

External-Connection non-submerged Imp DEVICE

Through a surgical procedure, we will implant implant whit external connection and non submerged to patients.

External-Connection non-submerged Imp

Internal Connection Submerged implants DEVICE

Through a surgical procedure, we will implant implant whit internal connection and submerged to patients.

Internal Connection Submerged implants

Internal Connection non-Submerged Impl DEVICE

Through a surgical procedure, we will implant implant whit internal connection and non-submerged to patients.

Internal Connection non-Submerged Impl

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Natalia Palacios Garzon

Barcelona, 08232, Spain

Location

Related Publications (3)

• 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.

  PMID: 24892113 BACKGROUND

• Penarrocha-Diago MA, Flichy-Fernandez AJ, Alonso-Gonzalez R, Penarrocha-Oltra D, Balaguer-Martinez J, Penarrocha-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.

  PMID: 22925048 BACKGROUND

• Galindo-Moreno P, Fernandez-Jimenez A, O'Valle F, Monje A, Silvestre FJ, Juodzbalys G, Sanchez-Fernandez 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.

  PMID: 25830399 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Natalia Palacios Garzón, PhD student

  HUBellvitge Recruiting

  PRINCIPAL INVESTIGATOR

• José López López, PhD

  Hospital Universitari de Bellvitge

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blind study The RX examiner and the person performing the resonance frequency measurements would be independent of the surgeons who placed the implants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student (Universitat de Barcelona)

Model Details: To randomize we will use the application created by a computer programmer that generates random numbers. In each jaw, each edentulous space will be randomly assigned (A, B, C, D, ..). Following the alphabetical order to each letter will be assigned randomly the connection to use, as detailed below: * 2 edentulous spaces: A: c. External or c. Internal (random) B: the one that is pending (The type of internal connection (crestal or infracrestal) will be chosen at random.) * 3 edentulous spaces: A: c. External, c. Crestal or infracrestal internal B: randomly choose between the two remaining options C: the one that is pending

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 28, 2017
• Study Start: May 8, 2017
• Primary Completion: January 30, 2020
• Study Completion: February 17, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

ES (1)