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

NCT05766878 | Completed

• 1 other identifier: SHORT_1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Peri-Implantation Loss; Periodontal Bone Loss; Periimplantitis; Gingival Inflammation; Implant Complication; Osseointegration Failure of Dental Implant

Keywords

short implants; surface treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Periodontal indexes: Probing Depth

  The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.

• Implant Stability evaluation

  0-4 months.

• Bleeding on Probing

  The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.

• Suppuration on probing

  The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.

• Plaque index of peri-implant tissues

  The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.

Study Arms (2)

machined collar

ACTIVE COMPARATOR

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

anodized collar

EXPERIMENTAL

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

Interventions

implants placement DEVICE

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.

anodized collar; machined collar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy patients, with edentulous maxillary or mandibular ridge, requiring rehabilitation with two adjacent implants;
• at least 6 month after extraction;

You may not qualify if:

• post-extractive implants;
• sites requiring bone regeneration or maxillary sinus lift;
• general health problems that contraindicate implant treatment.

Sponsors & Collaborators

• University of Foggia: lead
• Universita degli Studi di Genova: collaborator
• University of Turin, Italy: collaborator

Study Sites (3)

Clinica Odontoiatrica, University of Foggia

Foggia, 71122, Italy

Location

University of Genoa

Genova, Italy

Location

University of Turin

Torino, 10121, Italy

Location

Related Publications (1)

• Longhi B, Pera F, Menini M, Bagnasco F, Pesce P, Caroprese M, Troiano G, Zhurakivska K. The Influence of Implant Surface Modification on Marginal Bone Loss and Periodontal Health: A Cross-Over Randomized Clinical Trial. Int J Dent. 2025 Sep 28;2025:8889144. doi: 10.1155/ijod/8889144. eCollection 2025.

  PMID: 41059354 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss; Peri-Implantitis; Gingivitis

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Giuseppe Troiano, DDS, PhD

  University of Foggia

  PRINCIPAL INVESTIGATOR

• Francesco Pera, DDS, PhD

  University of Turin, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 13, 2023
• Study Start: June 9, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)