NCT Number: NCT03455361
Evaluation of Bone Level Around Stark Conical Screw Implants With V-Blast Surface
Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
26 Implants were placed with a unique operative protocol in 4 private offices. A detailed informed consent was obtained from all patients. Surgical guides were used to achieve the idea implant position and axis.
Osteotomy drills were used in the sequence recommended by the implant manufacturer. Bone type was assessed by CT examinations using the classification proposed by Rebaudi.
All implants were tested by applying a lateral mild load with a probe in order to verify mobility immediately after placement.
Parameter used to assess a low primary stability were:
- insertion torque lower than 10 N / cm
- slight mobility of implant upon application of lateral load of 250 g After surgery, patients were instructed not to chew or to wear their removable dentures in the treated areas.
Follow-up post-operative visits were scheduled at 1 and 4 weeks. At 4-6 months after placement a periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored. Patients were recalled, examined, and periapical radiographs were taken for a minimum of 6 months.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- patient who had received Stark bone level V-Blast implants in 4 private offices in Italy
- patient subscribed a detailed informed consent
- same surgical protocol was applied
Exclusion criteria
- patient without Stark implant
Treatment and study plan
Primary outcomes
-
Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months
Time frame: 4 to 6 months
After 4-6 months, implant without good primary stability were evaluatd. A periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored.
Sponsors and collaborators
Lead sponsor
University of Milan
Other
Registry information
Official study title
Clinical Osteointegration of Bone Level Implants With Conical Shape and Textured Surface With Low Primary Stability
Acronym: STARKIMPLANT
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Mar 6, 2018
- Registry last updated
- Mar 29, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
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