NCT06178536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

2.5 years

First QC Date

December 6, 2023

Last Update Submit

December 20, 2023

Conditions

Surgical TechniqueImplant Surface

Outcome Measures

Primary Outcomes (3)

  • 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.

Study Arms (2)

Rex implant machined transcortical portion

EXPERIMENTAL

Implants in these group will have a machined portion at the neck of the implant

Procedure: Bone ConsumptionProcedure: Bone expansion

Rex implant roughened transcortical portion

ACTIVE COMPARATOR

Rex implants with a rough surface until the neck of the implant

Procedure: Bone ConsumptionProcedure: Bone expansion

Interventions

Bone ConsumptionPROCEDURE

The surgery will be done using a bone consumption protocol

Rex implant machined transcortical portionRex implant roughened transcortical portion
Bone expansionPROCEDURE

implants will be placed after a bone expansion protocol

Rex implant machined transcortical portionRex implant roughened transcortical portion

Eligibility Criteria

Age35 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 21, 2023

Study Start

June 3, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)