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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05766878
Other study ID # SHORT_1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 9, 2023
Est. completion date September 1, 2024

Study information

Verified date May 2024
Source University of Foggia
Contact Khrystyna Zhurakivska, DDS, PhD
Phone 0881588080
Email khrystyna.zhurakivska@unifg.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. The clinical outcomes will be compared for different surface treatments of implant neck and those of prosthetic components.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 1, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - healthy patients, with edentulous maxillary or mandibular ridge, requiring rehabilitation with two adjacent implants; - at least 6 month after extraction; Exclusion Criteria: - post-extractive implants; - sites requiring bone regeneration or maxillary sinus lift; - general health problems that contraindicate implant treatment.

Study Design


Intervention

Device:
implants placement
The intervention will consist of placement of two types of short implants (one with traditional machined collar and one with anodized collar). After their healing period, the prosthetic rehabilitation will be made.

Locations

Country Name City State
Italy Clinica Odontoiatrica, University of Foggia Foggia
Italy University of Genoa Genova
Italy University of Turin Torino

Sponsors (3)

Lead Sponsor Collaborator
University of Foggia Universita degli Studi di Genova, University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Marginal Bone remodeling around the implant The marginal bone remodeling will be evaluated by Radiographic examination. Periapical radiographs will be performed using paralleling technique with a Rinn-type positioner, customized for each patient at implant placement (T0), prosthetic restoration delivery (T1), and after 12 months (T2).Peri-implant bone levels will be measured at each time point as the linear distance (in mm) between implant platform and bone crest at mesial and distal aspects of each implant. A positive value will be assigned if the bone crest is coronal to the implant platform, whereas a negative value will be assigned if the first bone-to implant contact is apical to the implant platform. All measurements will be performed by two examiners, using measuring software (Image J). Each measurement will be performed three times at three different points. 0-4-12 months after implant placement
Secondary Periodontal indexes: Probing Depth Probing Depth (PD) will be calculated as the distance (in mm) from the gingival peri-implant margin to the bottom of the peri-implant pocket. The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Secondary Implant Stability evaluation Primary and secondary implant stability will be measured with resonance frequency analysis (RFA) and subsequently expressed as an implant stability quotient (ISQ). The Implant stability will be measured immediately after placement (T0) and at 4 months (T1) after placement, when the osseointegration is supposed to take place. 0-4 months.
Secondary Bleeding on Probing Bleeding on probing (BoP) will be scored dichotomously (Yes/No). The probing will be performed on 6 sites around the implant (3 buccal and 3 palatal/lingual) and appearance of blood will be registered (Yes). The final score will be expressed as number of bleeding sites/total of probed sites (%) The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Secondary Suppuration on probing Suppuration on probing (SUP) will be scored dichotomously (Yes/No). The probing will be performed on 6 sites around the implant (3 buccal and 3 palatal/lingual) and appearance of pus or purulent exudate will be registered (Yes). The final score will be expressed as number of suppurative sites/total of probed sites (%) The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Secondary Plaque index of peri-implant tissues Plaque Index (PI) will be calculated by assigning a binary score to each surface (1= plaque present, 0 = plaque absent). The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
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