Clinical trial NCT04707716: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complications: Inflammatory Reactions, Mechanical Complications
Keywords: MMP-8
marginal bone level
conometric concept - Acuris
crown retention
all-ceramic crown
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of marginal bone level
timeFrame: at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration
measure: Change of matrix metalloproteinase 8 level
timeFrame: 4 months after implant placement, 3, 6 and 12 months after integration of the implant crown
Secondary outcomes:
measure: Change of probing depth (PD)
timeFrame: at baseline, 4, 7, 10, 16 months after implantation
measure: Number of occurrences of chipping
timeFrame: measured after integration of implant crown 3, 6 and 12 months after restoration
measure: soft tissue maintenance
timeFrame: measured 4 months after implant placement and 3, 6 and 12 months after restoration
measure: technician satisfaction
timeFrame: measured 12 months after restoration
measure: dentist satisfaction
timeFrame: measured 12 months after restoration
measure: patient satisfaction
timeFrame: measured at baseline, 3 and 12 months after restoration
measure: Plaque Index (PI)
timeFrame: at baseline, 4, 7, 10 and 16 months after implantation
measure: Bleeding on Probing (BOP)
timeFrame: at baseline, 4, 7, 10 and 16 months after implantation
measure: Patient satisfaction concerning the implant crown
timeFrame: measured 12 months after restoration
measure: Number of occurrences of fractures
timeFrame: measured after integration of implant crown 3, 6 and 12 months after restoration
measure: Number of occurrences of screw loosening
timeFrame: measured after integration of implant crown 3, 6 and 12 months after restoration
measure: Number of occurrences of crown loosening
timeFrame: measured after integration of implant crown 3, 6 and 12 months after restoration
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics
Study officials:
affiliation: Department of Dental Medicine and Oral Health
name: Norbert Jakse, UnivProfDDr
role: PRINCIPAL_INVESTIGATOR
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