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OpenTrials
Completed

NCT Number: NCT06178536

Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges

The aim is to clinically and radiographically assess a novel wedge implant placed in narrow ridges.

* 60 wedge implants (Rex Implants, Columbus, OH, USA) will be placed using Piezosurgery® following either a bone consumption (n=30) or bone expansion technique (n=30). Each group (bone consumption and bone expansion) will be divided into 2 surface treatments: machined transcortical portion (n=15) and roughened transcortical portion (n=15). * Record the time needed to place each implant. * ISQ will be evaluated at Day 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement. * Periapical radiographs will be performed at implant placement, loading. and 1, 3, and 5 years after loading to assess marginal bone stability. * Buccal bone height and lingual and buccal bone thickness will be recorded post-intervention, at the time of functional loading, and at 12, 36, and 60 months after loading with CBCT. * Digital impressions will be taken post-operatively, at loading and at 12 months after loading to monitor gingival profile.

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Key information

Conditions

Surgical Technique Implant Surface

Age range

35 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph University

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Partially or totally edentulous patients presenting indications for a prosthetic rehabilitation supported by the upper or lower jaw implants on the basis of an accurate diagnosis and treatment planning;
  • the bone crest must be completely healed (at least six months after the loss of teeth);
  • the residual bone crest must have a width between 3 and 5 mm;
  • presence of at least 10 mm of bone height available for implant placement; 5) patient age > 18 years;
  • the patient must not wear any type of removable dentures on the treated area; 7) the patient must be capable of following the study protocol; and 8) written informed consent must be provided

Exclusion criteria

  • acute myocardial infarction within the last two months;
  • Uncontrolled coagulation disorders;
  • uncontrolled diabetes (HBA1c> 7.5);
  • radiation therapy to the head \\ neck region in the last 24 months;
  • immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;
  • past or present treatment with intravenous bisphosphonates;
  • psychological or psychiatric problems;
  • abuse of alcohol or drugs;

Treatment and study plan

Bone Consumption

Procedure

The surgery will be done using a bone consumption protocol

Bone expansion

Procedure

implants will be placed after a bone expansion protocol

Primary outcomes

  1. Implant stability

    Time frame: 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement.

    Implant stability quotient evaluation

  2. Bone stability

    Time frame: At 6 months, and at 12, 36, and 60 months after loading

    Periapical radiograph and CBCT

  3. Gingival profile monitoring

    Time frame: Day 0 of surgery, at 6 months and at 12 months.

    Digital impression superimposition

Sponsors and collaborators

Lead sponsor

Christian Makary

Other

Registry information

Official study title

Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges: Comparison of Bone Consuming and Bone Expanding Techniques for Implants Presenting Either Machined or Roughened Transcortical Portion

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2023
Registry last updated
Dec 21, 2023

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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