Implant Supported Single Crowns With Different Retention Modes
Primary Purpose
Complications: Inflammatory Reactions, Mechanical Complications
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
conometric concept Acuris system
screw retention
cementation
Sponsored by
About this trial
This is an interventional treatment trial for Complications: Inflammatory Reactions, Mechanical Complications focused on measuring MMP-8, marginal bone level, conometric concept - Acuris, crown retention, all-ceramic crown
Eligibility Criteria
Inclusion Criteria:
- capability of giving an informed consent
- good health as defined by the subjects medical history (no contraindications as described in the exclusion criteria below)
- age 18 to 99 years
- Good periodontal status: BOP < 20%, PI < 30%, no PD > 4mm
- No heavy smokers (< 10 cigarettes/day)
- at least 1 missing tooth in the premolar and molar region (with at least a mesial neighboring tooth/implant showing adequate hard- and soft tissue situation without the need of crestal hard- or soft tissue augmentation) either in the maxilla or in the mandible requiring implant therapy for reconstruction, requiring sinus floor augmentation or not.
Exclusion Criteria
- Insufficient bone volume for implant placement requiring GBR (guided bone regeneration) procedure in crestal area.
- Heavy Smokers (>10 cigarettes/day)
- Medication with a contraindication for implant therapy (especially antiresorptive therapy, ongoing or recently completed local radiotherapy, systematic diseases, ongoing immunosuppressive therapy, functional disorders like Bruxism).
- Skeletal immaturity.
- Any active malignancy or ongoing treatment for malignancy.
- An active infection (e.g. caries, gingivitis, periodontitis) at or in the neighboring area of the operative site.
- Pregnancy
- unable or unwilling to return for follow-up visits for a period of at least 16 months
Sites / Locations
- Medical University of Graz, Department of Dental Medicine and Oral Health, Division of Oral Surgery and OrthodonticsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
conometric concept (Acuris system)
screw retention
cementation
Arm Description
single implant crown retention using friction only
screw retained implant Crown fixation
cement retained implant Crown fixation
Outcomes
Primary Outcome Measures
Change of marginal bone level
assessed by single tooth x-ray; in mm
Change of matrix metalloproteinase 8 level
biomarker for Inflammation of peri-implant disease; in ng/ml
Secondary Outcome Measures
Change of probing depth (PD)
using a periodontal probe; in mm
Number of occurrences of chipping
visual check
soft tissue maintenance
Papilla Index (Jemt T, 1997), the index ranges from 0 to 4, while 2 and 3 indicate physiological outcome
technician satisfaction
evaluated using an individual questionnaire
dentist satisfaction
evaluated using an individual questionnaire
patient satisfaction
evaluated using OHIP-G 14 questionnaire. The following dimensions are captured by the OHIP-G 14: functional Limitation (e.g., "pronouncing any words because of problems with your teeth, mouth, dentures, or jaw?") and physical Pain (e.g., "Have you had painful aching in your mouth"). 14 questions are raised, which are answered using a rating scale from 0 (never) to 4 (very often).
Plaque Index (PI)
in percent
Bleeding on Probing (BOP)
in percent
Patient satisfaction concerning the implant crown
evaluated using an individual questionnaire
Number of occurrences of fractures
visual check
Number of occurrences of screw loosening
visual check
Number of occurrences of crown loosening
visual check
Full Information
NCT ID
NCT04707716
First Posted
January 12, 2021
Last Updated
October 18, 2023
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT04707716
Brief Title
Implant Supported Single Crowns With Different Retention Modes
Official Title
Implant Supported Single Crowns With Different Retention Modes - Effects on Peri-implant Tissue: A Prospective Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
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
This study aims to examine the inflammatory response mediated by MMP-8 (Matrix metalloproteinase-8 ) level in peri-implant sulcus fluid adjacent to screw-retained, cemented or using the Acuris-system fixed single implant crowns as well as changing of the marginal bone level within the first year after implant restoration. Furthermore periodontal parameters, patient satisfaction and possible occurring biological or technical complications will be evaluated.
Detailed Description
After giving their written consent volunteers will be screened and eligible subjects will be randomized to three different groups. In group 1 Acuris® is used as fixation type; in group 2 screw retention, and in group 3 cementation is used. After 3 months of submerged healing the dental implants will be restored with all ceramic single implant crowns, fixed by using the randomized fixation mode. Follow-up visits till one year after implant restoration will be performed. At least 11 study visits during 16 months will be conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications: Inflammatory Reactions, Mechanical Complications
Keywords
MMP-8, marginal bone level, conometric concept - Acuris, crown retention, all-ceramic crown
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conometric concept (Acuris system)
Arm Type
Experimental
Arm Description
single implant crown retention using friction only
Arm Title
screw retention
Arm Type
Active Comparator
Arm Description
screw retained implant Crown fixation
Arm Title
cementation
Arm Type
Active Comparator
Arm Description
cement retained implant Crown fixation
Intervention Type
Other
Intervention Name(s)
conometric concept Acuris system
Intervention Description
implant crown retention type using friction only
Intervention Type
Other
Intervention Name(s)
screw retention
Intervention Description
screw retained implant crown
Intervention Type
Other
Intervention Name(s)
cementation
Intervention Description
cement retained implant crown
Primary Outcome Measure Information:
Title
Change of marginal bone level
Description
assessed by single tooth x-ray; in mm
Time Frame
at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration
Title
Change of matrix metalloproteinase 8 level
Description
biomarker for Inflammation of peri-implant disease; in ng/ml
Time Frame
4 months after implant placement, 3, 6 and 12 months after integration of the implant crown
Secondary Outcome Measure Information:
Title
Change of probing depth (PD)
Description
using a periodontal probe; in mm
Time Frame
at baseline, 4, 7, 10, 16 months after implantation
Title
Number of occurrences of chipping
Description
visual check
Time Frame
measured after integration of implant crown 3, 6 and 12 months after restoration
Title
soft tissue maintenance
Description
Papilla Index (Jemt T, 1997), the index ranges from 0 to 4, while 2 and 3 indicate physiological outcome
Time Frame
measured 4 months after implant placement and 3, 6 and 12 months after restoration
Title
technician satisfaction
Description
evaluated using an individual questionnaire
Time Frame
measured 12 months after restoration
Title
dentist satisfaction
Description
evaluated using an individual questionnaire
Time Frame
measured 12 months after restoration
Title
patient satisfaction
Description
evaluated using OHIP-G 14 questionnaire. The following dimensions are captured by the OHIP-G 14: functional Limitation (e.g., "pronouncing any words because of problems with your teeth, mouth, dentures, or jaw?") and physical Pain (e.g., "Have you had painful aching in your mouth"). 14 questions are raised, which are answered using a rating scale from 0 (never) to 4 (very often).
Time Frame
measured at baseline, 3 and 12 months after restoration
Title
Plaque Index (PI)
Description
in percent
Time Frame
at baseline, 4, 7, 10 and 16 months after implantation
Title
Bleeding on Probing (BOP)
Description
in percent
Time Frame
at baseline, 4, 7, 10 and 16 months after implantation
Title
Patient satisfaction concerning the implant crown
Description
evaluated using an individual questionnaire
Time Frame
measured 12 months after restoration
Title
Number of occurrences of fractures
Description
visual check
Time Frame
measured after integration of implant crown 3, 6 and 12 months after restoration
Title
Number of occurrences of screw loosening
Description
visual check
Time Frame
measured after integration of implant crown 3, 6 and 12 months after restoration
Title
Number of occurrences of crown loosening
Description
visual check
Time Frame
measured after integration of implant crown 3, 6 and 12 months after restoration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
capability of giving an informed consent
good health as defined by the subjects medical history (no contraindications as described in the exclusion criteria below)
age 18 to 99 years
Good periodontal status: BOP < 20%, PI < 30%, no PD > 4mm
No heavy smokers (< 10 cigarettes/day)
at least 1 missing tooth in the premolar and molar region (with at least a mesial neighboring tooth/implant showing adequate hard- and soft tissue situation without the need of crestal hard- or soft tissue augmentation) either in the maxilla or in the mandible requiring implant therapy for reconstruction, requiring sinus floor augmentation or not.
Exclusion Criteria
Insufficient bone volume for implant placement requiring GBR (guided bone regeneration) procedure in crestal area.
Heavy Smokers (>10 cigarettes/day)
Medication with a contraindication for implant therapy (especially antiresorptive therapy, ongoing or recently completed local radiotherapy, systematic diseases, ongoing immunosuppressive therapy, functional disorders like Bruxism).
Skeletal immaturity.
Any active malignancy or ongoing treatment for malignancy.
An active infection (e.g. caries, gingivitis, periodontitis) at or in the neighboring area of the operative site.
Pregnancy
unable or unwilling to return for follow-up visits for a period of at least 16 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Steyer, Dr.
Phone
0043 69911221489
Email
elisabeth.amberger@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Norbert Jakse, UnivProfDDr
Phone
0043 316 385
Ext
82921
Email
norbert.jakse@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Jakse, UnivProfDDr
Organizational Affiliation
Department of Dental Medicine and Oral Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz, Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics
City
Graz
ZIP/Postal Code
8010
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Jakse, MD
Email
norbert.jakse@medunigraz.at
12. IPD Sharing Statement
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Implant Supported Single Crowns With Different Retention Modes
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