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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369170
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Mozo Grau S.A.
Information provided by (Responsible Party):
Juan Blanco Carrión, University of Santiago de Compostela

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Periimplant Bone Loss Marginal Periimplant Bone Level Periimplantitis Device: prosthesis connected directly to the implants Device: Intermediate abutment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel blinded clinical trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Participant and care provider are blinded, the outcomes assessor is also masked but the investigator knows if the participant belongs to group A or B when the data is recorded
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : October 25, 2020
Estimated Study Completion Date : October 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Adverse events [ Time Frame: 12 months after the connection of the definitive prosthesis ]
    prostheses fracture, implant fracture, biological complications

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369170


Locations
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Spain
University of Santiago de Compostela
Santiago De Compostela, La Coruña, Spain, 15782
Sponsors and Collaborators
University of Santiago de Compostela
Mozo Grau S.A.
Publications:

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Responsible Party: Juan Blanco Carrión, Professor, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT04369170    
Other Study ID Numbers: ECIMG07/17
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases