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

Not Applicable

Completed

• Conditions: Implant Surface; Surgical Technique
• Interventions: Procedure: Bone Consumption; Procedure: Bone expansion

• Registration Number: NCT06178536
• Lead Sponsor: Christian Makary

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-03
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rex implant machined transcortical portion	Bone Consumption	Implants in these group will have a machined portion at the neck of the implant
Rex implant machined transcortical portion	Bone expansion	Implants in these group will have a machined portion at the neck of the implant
Rex implant roughened transcortical portion	Bone Consumption	Rex implants with a rough surface until the neck of the implant
Rex implant roughened transcortical portion	Bone expansion	Rex implants with a rough surface until the neck of the implant

Primary Outcome Measures

Name	Time	Method
Implant stability	0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement.	Implant stability quotient evaluation
Bone stability	At 6 months, and at 12, 36, and 60 months after loading	Periapical radiograph and CBCT
Gingival profile monitoring	Day 0 of surgery, at 6 months and at 12 months.	Digital impression superimposition

Trial Locations

Locations (1)

Saint Joseph University; 🇱🇧 Beirut, Lebanon