Evaluation of Bone Level Around Stark Conical Screw Implants With V-Blast Surface

Dental Impaction Clinical Trial

— STARKIMPLANT  

Official title:

Clinical Osteointegration of Bone Level Implants With Conical Shape and Textured Surface With Low Primary Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455361
• Other study ID #: StarkImplant
• Status: Completed
• First received: February 16, 2018
• Last updated: March 27, 2018
• Start date: March 1, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2018
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Impaction
• Tooth, Impacted

Intervention

Procedure:
• Stark Implant with low primary stability

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 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.	4 to 6 months