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

C

Christian Makary

Status

Completed

Conditions

Surgical Technique
Implant Surface

Treatments

Procedure: Bone Consumption
Procedure: Bone expansion

Study type

Interventional

Funder types

Other

Identifiers

NCT06178536
XFMD128

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

35 to 62 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. 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;
  2. the bone crest must be completely healed (at least six months after the loss of teeth);
  3. the residual bone crest must have a width between 3 and 5 mm;
  4. presence of at least 10 mm of bone height available for implant placement; 5) patient age > 18 years;
  1. 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

18 participants in 2 patient groups

Rex implant machined transcortical portion
Experimental group
Description:
Implants in these group will have a machined portion at the neck of the implant
Treatment:
Procedure: Bone expansion
Procedure: Bone Consumption
Rex implant roughened transcortical portion
Active Comparator group
Description:
Rex implants with a rough surface until the neck of the implant
Treatment:
Procedure: Bone expansion
Procedure: Bone Consumption

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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