Implant Supported Single Crowns With Different Retention Modes

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT04707716

Collaborator

(none)

Enrollment

Location

Arms

31.9

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Complications: Inflammatory Reactions, Mechanical Complications	Other: conometric concept Acuris system Other: screw retention Other: cementation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Implant Supported Single Crowns With Different Retention Modes - Effects on Peri-implant Tissue: A Prospective Randomized Controlled Clinical Trial

Actual Study Start Date :

Mar 4, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: conometric concept (Acuris system) single implant crown retention using friction only	Other: conometric concept Acuris system implant crown retention type using friction only
Active Comparator: screw retention screw retained implant Crown fixation	Other: screw retention screw retained implant crown
Active Comparator: cementation cement retained implant Crown fixation	Other: cementation cement retained implant crown

Arm

Intervention/Treatment

Experimental: conometric concept (Acuris system)

single implant crown retention using friction only

Other: conometric concept Acuris system

implant crown retention type using friction only

Active Comparator: screw retention

screw retained implant Crown fixation

Other: screw retention

screw retained implant crown

Active Comparator: cementation

cement retained implant Crown fixation

Other: cementation

cement retained implant crown

Outcome Measures

Primary Outcome Measures

Change of marginal bone level [at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration]
assessed by single tooth x-ray; in mm
Change of matrix metalloproteinase 8 level [4 months after implant placement, 3, 6 and 12 months after integration of the implant crown]
biomarker for Inflammation of peri-implant disease; in ng/ml

Secondary Outcome Measures

Change of probing depth (PD) [at baseline, 4, 7, 10, 16 months after implantation]
using a periodontal probe; in mm
Number of occurrences of chipping [measured after integration of implant crown 3, 6 and 12 months after restoration]
visual check
soft tissue maintenance [measured 4 months after implant placement and 3, 6 and 12 months after restoration]
Papilla Index (Jemt T, 1997), the index ranges from 0 to 4, while 2 and 3 indicate physiological outcome
technician satisfaction [measured 12 months after restoration]
evaluated using an individual questionnaire
dentist satisfaction [measured 12 months after restoration]
evaluated using an individual questionnaire
patient satisfaction [measured at baseline, 3 and 12 months after restoration]
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) [at baseline, 4, 7, 10 and 16 months after implantation]
in percent
Bleeding on Probing (BOP) [at baseline, 4, 7, 10 and 16 months after implantation]
in percent
Patient satisfaction concerning the implant crown [measured 12 months after restoration]
evaluated using an individual questionnaire
Number of occurrences of fractures [measured after integration of implant crown 3, 6 and 12 months after restoration]
visual check
Number of occurrences of screw loosening [measured after integration of implant crown 3, 6 and 12 months after restoration]
visual check
Number of occurrences of crown loosening [measured after integration of implant crown 3, 6 and 12 months after restoration]
visual check

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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