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

Surgical Technique Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06178536
• Other study ID #: XFMD128
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 62 Years

Eligibility

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;

Related Conditions & MeSH terms

• Mouth, Edentulous
• Surgical Technique

Intervention

Procedure:
• Bone Consumption
The surgery will be done using a bone consumption protocol
• Bone expansion
implants will be placed after a bone expansion protocol

Locations

Country	Name	City	State
Lebanon	Saint Joseph University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Christian Makary

Country where clinical trial is conducted

Lebanon, 

Outcome

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