The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics

Implant Complication Clinical Trial

Official title:

The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics: Multicentric RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766878
• Other study ID #: SHORT_1
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2023
• Source: University of Foggia
• Contact: Khrystyna Zhurakivska, DDS, PhD
• Phone: 0881588080
• Email: khrystyna.zhurakivska[@]unifg.it
• Is FDA regulated: No
• 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: March 1, 2024
• Est. primary completion date: December 31, 2023
• 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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Gingival Inflammation
• Gingivitis
• Implant Complication
• Inflammation
• Osseointegration Failure of Dental Implant
• Peri-Implantitis
• Periimplantitis
• Periodontal Bone Loss

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.