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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Technique; Implant Surface
• Intervention / Treatment: Procedure: Bone Consumption; Procedure: Bone expansion

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rex implant machined transcortical portion; Implants in these group will have a machined portion at the neck of the implant	Procedure: Bone Consumption; The surgery will be done using a bone consumption protocol; Procedure: Bone expansion; implants will be placed after a bone expansion protocol
Active Comparator: Rex implant roughened transcortical portion; Rex implants with a rough surface until the neck of the implant	Procedure: Bone Consumption; The surgery will be done using a bone consumption protocol; Procedure: Bone expansion; implants will be placed after a bone expansion protocol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Christian Makary

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Estimated): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: XFMD128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No