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

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;

6. 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

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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