Back to resultsEffect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
Primary Purpose
Jaw, Edentulous, Partially
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Connect®
Multi-unit
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially
Eligibility Criteria
Inclusion criteria: Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar. Possibility of placing a transgingival abutment at least 2 mm high. Exclusion criteria: Need for simultaneous bone augmentation. Heavy smokers (>10 cigarettes/day). Uncontrolled type 1 or 2 diabetes (HgA1c>8). Known autoimmune or inflammatory disease. Serious blood disorders, such as hemophilia or leukemia. Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology). Liver or kidney dysfunction/failure. Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy. Long-term history of oral bisphosphonates use (i.e., 10 years or more). History of intravenous bisphosphonates. Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion. Severe osseous diseases (e.g., Paget disease of bone). Pregnant women or nursing mothers. Not able or not willing to follow instructions related to the study procedures.
Sites / Locations
- Universidad de GranadaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Connect®
Multi-unit
Arm Description
Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.
Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.
Outcomes
Primary Outcome Measures
Marginal bone level
Peri-implant marginal bone level measured by standardized periapical radiography
Secondary Outcome Measures
Peri-implant microbiome
Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods
Peri-implant inflammation
Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05883202
Brief Title
Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
Official Title
Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. However, for multiple restorations, the abutment-prosthesis connection has not been studied in detail. The "multi-unit" systems, both standard and brand specific, have either a flat or butt joint or an cone. In any case, both are external connection systems. Recently, an internal-type abutment-prosthesis connection system has been developed. Although it is proving its usefulness in single restorations, its use in multiple restorations compared to traditional systems has not been studied.
Therefore, taking into account all of the above, the present study has the overall objective of analyzing marginal bone loss (MBL) and adaptation of soft tissues by comparing a multiple prosthesis system of the "external, flat" type versus an external system of the "internal, conical" type.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Connect®
Arm Type
Experimental
Arm Description
Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.
Arm Title
Multi-unit
Arm Type
Active Comparator
Arm Description
Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.
Intervention Type
Device
Intervention Name(s)
Connect®
Intervention Description
Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.
Intervention Type
Device
Intervention Name(s)
Multi-unit
Intervention Description
Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.
Primary Outcome Measure Information:
Title
Marginal bone level
Description
Peri-implant marginal bone level measured by standardized periapical radiography
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Peri-implant microbiome
Description
Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods
Time Frame
1 year
Title
Peri-implant inflammation
Description
Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Soft-tissue volume
Description
Three-dimensional volume of the soft tissue around the implants
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar.
Possibility of placing a transgingival abutment at least 2 mm high.
Exclusion criteria:
Need for simultaneous bone augmentation.
Heavy smokers (>10 cigarettes/day).
Uncontrolled type 1 or 2 diabetes (HgA1c>8).
Known autoimmune or inflammatory disease.
Serious blood disorders, such as hemophilia or leukemia.
Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).
Liver or kidney dysfunction/failure.
Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy.
Long-term history of oral bisphosphonates use (i.e., 10 years or more).
History of intravenous bisphosphonates.
Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion.
Severe osseous diseases (e.g., Paget disease of bone).
Pregnant women or nursing mothers.
Not able or not willing to follow instructions related to the study procedures.
Facility Information:
Facility Name
Universidad de Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Padial-Molina, DDS, PhD
Email
mipadial@ugr.es
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24621670
Citation
Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, Suarez F, OValle F, Spinato S, Catena A. Prosthetic Abutment Height is a Key Factor in Peri-implant Marginal Bone Loss. J Dent Res. 2014 Jul;93(7 Suppl):80S-85S. doi: 10.1177/0022034513519800. Epub 2014 Mar 12.
Results Reference
background
PubMed Identifier
32865627
Citation
Couso-Queiruga E, Tattan M, Ahmad U, Barwacz C, Gonzalez-Martin O, Avila-Ortiz G. Assessment of gingival thickness using digital file superimposition versus direct clinical measurements. Clin Oral Investig. 2021 Apr;25(4):2353-2361. doi: 10.1007/s00784-020-03558-0. Epub 2020 Aug 31.
Results Reference
background
Learn more about this trial
Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
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