Changes on the Interproximal Bone Level on Direct Prostheses or With Intermediate Abutments
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|ClinicalTrials.gov Identifier: NCT04369170|
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
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|
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 (Clinical Trial)|
|Actual Enrollment :||37 participants|
|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|
|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|
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
- 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
- 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
- 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
- Adverse events [ Time Frame: 12 months after the connection of the definitive prosthesis ]prostheses fracture, implant fracture, biological complications
- 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
- 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
- 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
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
|University of Santiago de Compostela|
|Santiago De Compostela, La Coruña, Spain, 15782|