Surgical TechniqueNCT06178536
Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges
A study testing Bone Consumption and Bone expansion in people with Surgical Technique and Implant Surface, run by Christian Makary at 1 site in Lebanon.
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). Read more about this study
- Who is it for?
- Ages 35 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Technique, Implant Surface
- What is being tested?
- Bone Consumption and Bone expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteLebanon
- Study dates
- 3 Jun 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Surgical Technique, Implant Surface
- Being tested
- Bone Consumption, Bone expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone ConsumptionProcedure or surgery
The surgery will be done using a bone consumption protocol
Bone expansionProcedure or surgery
implants will be placed after a bone expansion protocol
| Study group | Role | What they receive |
|---|---|---|
| Rex implant machined transcortical portion | Experimental | Implants in these group will have a machined portion at the neck of the implant Receives: Procedure: Bone Consumption; Procedure: Bone expansion |
| Rex implant roughened transcortical portion | Active comparator | Rex implants with a rough surface until the neck of the implant Receives: Procedure: Bone Consumption; Procedure: Bone expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Implant stability quotient evaluation
Measured: 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement.
Bone stability
Periapical radiograph and CBCT
Measured: At 6 months, and at 12, 36, and 60 months after loading
Gingival profile monitoring
Digital impression superimposition
Measured: Day 0 of surgery, at 6 months and at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start3 Jun 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical TechniqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Makary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Makary, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178536
- Sponsor's protocol ID
- XFMD128
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06178536
- Acronym / sponsor ID
- XFMD128
- Conditions
- Surgical Technique, Implant Surface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Christian MakaryUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rex implant machined transcortical portion | Experimental | Procedure: Bone Consumption, Procedure: Bone expansionImplants in these group will have a machined portion at the neck of the implant |
| Rex implant roughened transcortical portion | Active comparator | Procedure: Bone Consumption, Procedure: Bone expansionRex implants with a rough surface until the neck of the implant |
Who may qualify
- Ages
- 35 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone ConsumptionThe surgery will be done using a bone consumption protocol | Procedure or surgery | Rex implant machined transcortical portion, Rex implant roughened transcortical portion |
| Bone expansionimplants will be placed after a bone expansion protocol | Procedure or surgery | Rex implant machined transcortical portion, Rex implant roughened transcortical portion |
Primary outcome
Implant stability
Time frame: 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement.
Implant stability quotient evaluation
Bone stability
Time frame: At 6 months, and at 12, 36, and 60 months after loading
Periapical radiograph and CBCT
Gingival profile monitoring
Time frame: Day 0 of surgery, at 6 months and at 12 months.
Digital impression superimposition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Consumption and Bone expansion in people with Surgical Technique and Implant Surface, run by Christian Makary at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.