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NCT Number: NCT05766878

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

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.

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Key information

Conditions

Peri-Implantation Loss Alveolar Bone Loss Bone Diseases Bone Resorption Gingival Diseases Gingival Inflammation Gingivitis Implant Complication Infections Mouth Diseases Musculoskeletal Diseases Osseointegration Failure of Dental Implant Peri-Implantitis Periimplantitis Periodontal Atrophy Periodontal Bone Loss Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Odontoiatrica, University of Foggia, Foggia, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Marginal Bone remodeling around the implant

    Time frame: 0-4-12 months after implant placement

    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 outcomes

  1. Periodontal indexes: Probing Depth

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

    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.

  2. Implant Stability evaluation

    Time frame: 0-4 months.

    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.

  3. Bleeding on Probing

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

    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 (%)

  4. Suppuration on probing

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

    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 (%)

  5. Plaque index of peri-implant tissues

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

    Plaque Index (PI) will be calculated by assigning a binary score to each surface (1= plaque present, 0 = plaque absent).

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Collaborators

  • Universita degli Studi di Genova
  • University of Turin, Italy

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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