Medical University of Graz, Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics
Graz, 8010, Austria
NCT Number: NCT04707716
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.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Graz, 8010, Austria
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
implant crown retention type using friction only
screw retained implant crown
cement retained implant crown
Time frame: at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration
assessed by single tooth x-ray; in mm
Time frame: 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
Time frame: at baseline, 4, 7, 10, 16 months after implantation
using a periodontal probe; in mm
Time frame: measured after integration of implant crown 3, 6 and 12 months after restoration
visual check
Time frame: 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
Time frame: measured 12 months after restoration
evaluated using an individual questionnaire
Time frame: measured 12 months after restoration
evaluated using an individual questionnaire
Time frame: 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).
Time frame: at baseline, 4, 7, 10 and 16 months after implantation
in percent
Time frame: at baseline, 4, 7, 10 and 16 months after implantation
in percent
Time frame: measured 12 months after restoration
evaluated using an individual questionnaire
Time frame: measured after integration of implant crown 3, 6 and 12 months after restoration
visual check
Time frame: measured after integration of implant crown 3, 6 and 12 months after restoration
visual check
Time frame: measured after integration of implant crown 3, 6 and 12 months after restoration
visual check
Medical University of Graz
Other
Implant Supported Single Crowns With Different Retention Modes - Effects on Peri-implant Tissue: A Prospective Randomized Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.