Back to resultsThe Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics
Primary Purpose
Peri-Implantation Loss, Periodontal Bone Loss, Periimplantitis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
implants placement
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantation Loss focused on measuring short implants, surface treatment
Eligibility Criteria
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.
Sites / Locations
- Clinica Odontoiatrica, University of FoggiaRecruiting
- University of Genoa
- University of TurinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
machined collar
anodized collar
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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 (%)
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 (%)
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).
Full Information
NCT ID
NCT05766878
First Posted
February 10, 2023
Last Updated
June 9, 2023
Sponsor
University of Foggia
Collaborators
Universita degli Studi di Genova, University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT05766878
Brief Title
The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics
Official Title
The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics: Multicentric RCT
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Foggia
Collaborators
Universita degli Studi di Genova, University of Turin, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantation Loss, Periodontal Bone Loss, Periimplantitis, Gingival Inflammation, Implant Complication, Osseointegration Failure of Dental Implant
Keywords
short implants, surface treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
machined collar
Arm Type
Active Comparator
Arm Description
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.
Arm Title
anodized collar
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
implants placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Marginal Bone remodeling around the implant
Description
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.
Time Frame
0-4-12 months after implant placement
Secondary Outcome Measure Information:
Title
Periodontal indexes: Probing Depth
Description
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.
Time Frame
The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Title
Implant Stability evaluation
Description
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.
Time Frame
0-4 months.
Title
Bleeding on Probing
Description
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 (%)
Time Frame
The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Title
Suppuration on probing
Description
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 (%)
Time Frame
The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Title
Plaque index of peri-implant tissues
Description
Plaque Index (PI) will be calculated by assigning a binary score to each surface (1= plaque present, 0 = plaque absent).
Time Frame
The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khrystyna Zhurakivska, DDS, PhD
Phone
0881588080
Ext
+39
Email
khrystyna.zhurakivska@unifg.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Troiano, DDS, PhD
Organizational Affiliation
University of Foggia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Pera, DDS, PhD
Organizational Affiliation
University of Turin, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Clinica Odontoiatrica, University of Foggia
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khrystyna Zhurakivska, DDS, PhD
Phone
0881588080
Email
khrystyna.zhurakivska@unifg.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Troiano, DDS, PhD
Facility Name
University of Genoa
City
Genova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Menini, DDS, PhD
Email
maria.menini@unige.it
Facility Name
University of Turin
City
Torino
ZIP/Postal Code
10121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Pera, DDS, PhD
Email
francesco.pera@unito.it
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data, in compliance with the privacy protection rules, will be shared upon request.
Learn more about this trial
The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics
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