Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT03455361
Brief Summary:
Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.
Detailed 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.
Study:
NCT03455361
Study Brief:
Protocol Section:
NCT03455361