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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Bone Loss; Implant Complication; Gingival Inflammation; Periimplantitis; Osseointegration Failure of Dental Implant; Peri-Implantation Loss
• Intervention / Treatment: Device: implants placement

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khrystyna Zhurakivska, DDS, PhD; Phone Number: +39 0881588080; Email: khrystyna.zhurakivska@unifg.it

Study Locations

• Italy
  • Foggia, Italy, 71122
    • Recruiting
    • Clinica Odontoiatrica, University of Foggia
    • Contact: Khrystyna Zhurakivska, DDS, PhD; Phone Number: 0881588080; Email: khrystyna.zhurakivska@unifg.it
    • Principal Investigator: Giuseppe Troiano, DDS, PhD
  • Genova, Italy
    • Not yet recruiting
    • University of Genoa
    • Contact: Maria Menini, DDS, PhD; Email: maria.menini@unige.it
  • Torino, Italy, 10121
    • Recruiting
    • University of Turin
    • Contact: Francesco Pera, DDS, PhD; Email: francesco.pera@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: machined collar; The arm will be constituted by healthy people, that need to be rehabilitated by dental implant placement. A short implant (length 6mm; diameter 4.3) will be inserted in an edentulous site. The implant will present a surface treated with double acid etching and traditional machined collar. A definitive transgingival standard machined abutment will be immediately screwed. Four months later, prosthetic procedures will start.	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.
Experimental: anodized collar; The arm will be constituted by healthy people, that need to be rehabilitated by dental implant placement. A short implant (length 6mm; diameter 4.3) will be inserted in an edentulous site. The implant will present a surface treated with double acid etching and anodized collar. A definitive transgingival anodized abutment will be immediately screwed. Four months later, prosthetic procedures will start.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Foggia
• Collaborators: University of Turin, Italy; Universita degli Studi di Genova
• Investigators: Principal Investigator: Giuseppe Troiano, DDS, PhD, University of Foggia; Study Chair: Francesco Pera, DDS, PhD, University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: short implants; surface treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Inflammation; Gingivitis; Peri-Implantitis; Alveolar Bone Loss
• Other Study ID Numbers: SHORT_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data, in compliance with the privacy protection rules, will be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No