Changes on the Interproximal Bone Level on Direct Prostheses or With Intermediate Abutments

September 28, 2021 updated by: Juan Blanco Carrión, University of Santiago de Compostela

Changes on the Interproximal Marginal Bone Level After CAD-CAM Designed Bridges Directly Placed on Bone-level Implants, or With Intermediate Abutments. A Randomized Clinical Trial

Study Title: Changes on the Interproximal marginal bone level after CAD-CAM designed bridges directly placed on bone-level implants, or with intermediate abutments. A Randomized Clinical Trial.

  • Objectives: To evaluate differences on changes on the interproximal marginal bone level 12 months after the connection of CAD/CAM designed prosthesis with an intermediate abutment (3mm long) or directly placed to bonelevel implants. Secondary objectives will be evaluate changes on the soft tissues and implant survival, as well as patients' satisfaction 3, 6 and 12 months after the connection of the definitive prosthesis.
  • Design and Outcomes: Randomized double-blinded clinical trial with parallel design to asses the effect of CADCAM designed bridges directly placed
  • Interventions and Duration: Patients will be selected according to the inclusion/exclusion criteria among those who attend the Unit of Periodontology of the University of Santiago de Compostela. After clinical and radiological implant planning, implant surgical placement will be scheduled. 2 MOZO GRAU® INHEX ST implants, with 3.75 mm or 4.25 mm of diameter and 8mm, 10mm or 11.5mm length will be placed on each patient, according to the bone availability. After 8 weeks of submerged healing, second stage surgery will be performed and definitive impression will be taken. All groups patients will keep a heeling abutment until the definitive prosthesis is placed, 3 weeks later (test group: direct to implant / control group: abutment 3 mm long). Clinical and radiological assessment after 1, 3, 6 and 12 months will be performed. Each participant will be on study about 15 months since the recruitment visit until the end of the study.
  • Sample Size and Population: Based on previous studies, a sample size calculation determined that a group of 32 subjects, considering possible dropouts, will provide 80% power to detect a true radiographic difference of 0.80mm between groups after 12 months of observation since the definitive prosthesis connection. (Blanco et al 2017, Nóvoa et al 2017). A common standard deviation between groups was calculated (SD=0.715268015). A p ≤ 0.05 value will be considered significant (JM. Domenech & R. Granero 2010). A balanced random permuted block will be applied to prepare the randomization tables, stratifying for smoking habits (yes/no) with a 1:1 ratio between test and control groups.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Changes on the interproximal periimplant marginal bone level measured as the distance between the bone crest to the first implant to bone contact, using periapical radiographs, will be evaluated.

Each patient will receive to implants that will be rehabilitated with an implant supported prosthesis, being the test group a prosthesis connected directly to the implants, while the control group will be a prosthesis connected to the implants through intermediate abutments.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • La Coruña
      • Santiago De Compostela, La Coruña, Spain, 15782
        • University of Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with systemic and periodontal health, over 18 years old, with a Plaque Index lower than 25%.

    • Patients with an absence of at least two contiguous teeth, with natural proximal teeth, excluding the anterior upper zone, allowing the rehabilitation with bridges with two implants and two to four prostheses units
    • Adequate bone quality available that allows the placement of MOZO GRAU® INHEX ST implants with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm.
    • At least 2mm of keratinized gingiva.
    • Natural antagonic teeth or implants with fixed restorations.

Exclusion Criteria:

  • • Systemic Factors:

    • Long term use of systemic medication that may interfere with bone metabolism or medical conditions that require prolonged use of steroids and / or medication that may interfere with bone metabolism
    • History of leukocyte dysfunction and deficiency, immunodeficiency syndromes, renal failure or bonemetabolic disorders such as osteoporosis
    • Physical disabilities that may interfere with proper oral hygiene
    • Use of any medication or device in research for a period of 30 days prior to the implant surgery in the study
    • Alcoholism or drug abuse
    • Smoker of more than 10 cigarettes per day
    • Conditions or circumstances which could prevent compliance with the participation in the study or interfere with the analysis of the results, such as a history of non-compliance or lack of reliability.
    • Local Factors:
    • History of local radiotherapy
    • Bruxism
    • Mucosal diseases, such as Oral Lichen Planus
    • Not treated periodontitis
    • Persistent intraoral infection
    • Crestal bone regeneration less than 3 months before the implant placement
    • Not healed extraction sockets (less than 6 weeks post-extraction
    • Anterior aesthetic sextant of the maxilla

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A - Control Group
Control group where an intermediate abutment is placed in between the CAD-CAM dental prostheses an the dental implant.
Device: Intermediate abutment
dental prostheses connected with an intermediate abutment to the implant
Experimental: Group B - Test Group
Test group where the CAD-CAM dental prostheses is connected directly to the dental implant
Device: prosthesis connected directly to the implants
dental prostheses connected directly to the dental implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Periimplant Marginal Bone Loss
Time Frame: 12 months after the connection of the definitive prosthesis
distance in millimetres measured on the periapical radiography between the implant neck and the first bone to implant contact after 12 months of loading
12 months after the connection of the definitive prosthesis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic parameters according to papilla refill between the prosthetic units
Time Frame: 12 months after the connection of the definitive prosthesis
Using the Jemt index 1997 to evaluate the papilla refill between the prosthetic units
12 months after the connection of the definitive prosthesis
PROM's - Patient Recorded Outcomes Measurements
Time Frame: 12 months after the connection of the definitive prosthesis
Visual Analogue Scale from 1 to 10 where the patient can evaluate the treatment according to aesthetics, chewing capacity, phonetics, confort and general satisfaction with the treatment
12 months after the connection of the definitive prosthesis
Adverse events
Time Frame: 12 months after the connection of the definitive prosthesis
prostheses fracture, implant fracture, biological complications
12 months after the connection of the definitive prosthesis
probing pocket depth
Time Frame: 12 months after the connection of the definitive prosthesis
measured with a CP12 calibrated periodontal probe from the gingival margin to the end of the periimplant pocket
12 months after the connection of the definitive prosthesis
Bleeding on probing
Time Frame: 12 months after the connection of the definitive prosthesis
presence of bleeding after probing pocket depth using the Mombelli index 1987
12 months after the connection of the definitive prosthesis
Plaque index
Time Frame: 12 months after the connection of the definitive prosthesis
presence of plaque on the implant supported rehabilitation using the Mombelli index 1987
12 months after the connection of the definitive prosthesis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Collaborators

Mozo Grau S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2019

Primary Completion (Anticipated)

October 25, 2021

Study Completion (Anticipated)

October 25, 2022

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECIMG07/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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