Completely Edentulous PatientsBLXNCT06334770
Influence of Roxolid Implant Material on the Implant Stability Implant Stability
A study testing Roxolid implants and Titanium implants in people with Completely Edentulous Patients, run by Ain Shams University at 1 site in Egypt.
Trial summary
Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Completely Edentulous Patients
- What is being tested?
- Roxolid implants and Titanium implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2021to 12 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous patients as the last extraction should be at least six months before implant placement.
- Patients with good oral hygiene.
- Sufficient inter arch space (11 mm) which were diagnosed by mounted diagnostic casts.
- Firm and healthy mucosa covering the residual alveolar ridge.
Who cannot join
- - Heavy smokers.
- Patients with para functional habits.
- Patients had TMJ disorders.
- Patients had systemic disease that could interfere with implant placement or affect bone healing such as; thyroid and uncontrolled diabetes.
- Patients undergoing chemo and radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Roxolid Implant Material on the Implant Stability of Maxillary Implant Retained Overdenture
Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University.
After fabrication of complete denture for all patients, patients were randomly divided to:
Read more
Group A: Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® implant were inserted opposed by mandibular complete denture.
Group B: Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture.
After implant placement using surgical guide, smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks, secondary stability was measured for both groups.
After four months, the second stage started in which exposure of the implant fixtures took place and pick up was carried out.
Patients were recalled frequently for post-insertion inspection and adjustment.
Read the detailed description
Background: long term success of implant restoration depends on many factors one of them is the sufficient implant stability which is lowered in compromised bone density sites such as the maxilla which is categorized as type III \& IV bone, so searching for new innovation and updates in implant material and features is very mandatory. So, the aim of this study was asses and compare between two implant materials roxolid versus traditional titanium on the primary and secondary stability.
Methods: eighteen completely edentulous patients were selected they all received maxillary implant retained overdentures and lower complete dentures, they were divided equally in to two groups according to the type of the material of the implants. Group A received a total number of 36 (Roxolid) Implants were made of roxolid material and Group B received a total number 36 (Titanium) implants were made of traditional titanium alloys. Implant stability was assed using ostell device, the primary implant stability was measured at the day of implant installation however, secondary implant stability was measured after six weeks of implant placement. Paired t-test was used to compare between primary and secondary stability in the same group and independent t-test was used to compare between the two groups with a significant level < 0.05.
- Conditions
- Completely Edentulous Patients
- Being tested
- Roxolid implants, Titanium implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roxolid implantsDevice
Also called Straumann BLX® SLA implants
four Straumann BLX® roxolid implant 15% zirconium and 85% titanium), 3.7 mm in diameter, and 10 mm in length.implants were selected with the following criteria: tapered, self-tapping, aggressively threaded,were inserted with novalock attachments.
Titanium implantsDevice
Also called JD EVOLUTION PLUS implants
four conventional acid etched pure implants tapered, self-tapping, threaded, two-piece, with the 10 mm length and 3.7 mm diameter were inserted with Sphero flex attachments.
| Study group | Role | What they receive |
|---|---|---|
| Group( A) ROXOLID IMPLANT | Experimental | NINE patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® ROXOLID implant were inserted opposed by mandibular complete denture. Receives: Device: Roxolid implants |
| Group (B) CONVENTIONAL TITANIUM IMPLANT | Active comparator | NINE patients were rehabilitated with implant retained maxillary overdenture where four conventional titanium implants were inserted opposed by mandibular complete denture. Receives: Device: Titanium implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring primary at time of surgery
using an Ostell device with a smart peg to measure primary stability at the time of implant placement and measuring secondary stability after six weeks of implant placement.
Measured: same day of implant placement
Secondary outcomes (1)
secondary implant stability after 6 weeks
measuring secondary stability using ostell device and smart peg
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start15 Jun 2021
- Primary completion22 Jan 2022
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Completely Edentulous PatientsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Ibrahim, Ain Shams University
- Investigators
- shaimaa L mohamed, PROFESSOR, Principal investigator, Ains hams univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334770
- Sponsor's protocol ID
- FDASuRecD032136
- Acronym
- BLX
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: THE PROTOCOL OF OUR STUDY THAT WILL BE SHARED
Publications
Pandey C, Rokaya D, Bhattarai BP. Contemporary Concepts in Osseointegration of Dental Implants: A Review. Biomed Res Int. 2022 Jun 14;2022:6170452. doi: 10.1155/2022/6170452. eCollection 2022.
PubMed 35747499Thanasrisuebwong P, Pimkhaokham A, Jirajariyavej B, Bencharit S. Influence of the Residual Ridge Widths and Implant Thread Designs on Implant Positioning Using Static Implant Guided Surgery. J Prosthodont. 2023 Apr;32(4):340-346. doi: 10.1111/jopr.13557. Epub 2022 Jun 22.
PubMed 35686699El-Hady AIA, Eid HI, Mohamed SL, Fadl SM. Influence of titanium and titanium-zirconium alloy as implant materials on implant stability of maxillary implant retained overdenture: a randomized clinical trial. BMC Oral Health. 2024 Aug 6;24(1):902. doi: 10.1186/s12903-024-04692-x.
PubMed 39107737
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Roxolid Implant Material on the Implant Stability of Maxillary Implant Retained Overdenture
- ClinicalTrials.gov ID
- NCT06334770
- Acronym / sponsor ID
- BLX / FDASuRecD032136
- Conditions
- Completely Edentulous Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 28 Mar 2024 (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.
Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University.
After fabrication of complete denture for all patients, patients were randomly divided to:
Group A: Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® implant were inserted opposed by mandibular complete denture.
Group B: Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture.
After implant placement using surgical guide, smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks, secondary stability was measured for both groups.
After four months, the second stage started in which exposure of the implant fixtures took place and pick up was carried out.
Patients were recalled frequently for post-insertion inspection and adjustment.
Detailed description
Background: long term success of implant restoration depends on many factors one of them is the sufficient implant stability which is lowered in compromised bone density sites such as the maxilla which is categorized as type III \& IV bone, so searching for new innovation and updates in implant material and features is very mandatory. So, the aim of this study was asses and compare between two implant materials roxolid versus traditional titanium on the primary and secondary stability.
Methods: eighteen completely edentulous patients were selected they all received maxillary implant retained overdentures and lower complete dentures, they were divided equally in to two groups according to the type of the material of the implants. Group A received a total number of 36 (Roxolid) Implants were made of roxolid material and Group B received a total number 36 (Titanium) implants were made of traditional titanium alloys. Implant stability was assed using ostell device, the primary implant stability was measured at the day of implant installation however, secondary implant stability was measured after six weeks of implant placement. Paired t-test was used to compare between primary and secondary stability in the same group and independent t-test was used to compare between the two groups with a significant level < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group( A) ROXOLID IMPLANT | Experimental | Device: Roxolid implantsNINE patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® ROXOLID implant were inserted opposed by mandibular complete denture. |
| Group (B) CONVENTIONAL TITANIUM IMPLANT | Active comparator | Device: Titanium implantsNINE patients were rehabilitated with implant retained maxillary overdenture where four conventional titanium implants were inserted opposed by mandibular complete denture. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Completely edentulous patients as the last extraction should be at least six months before implant placement.
Key exclusion criteria (5 listed)
- - Heavy smokers.
- Patients with para functional habits.
- Patients had TMJ disorders.
- Patients had systemic disease that could interfere with implant placement or affect bone healing such as; thyroid and uncontrolled diabetes.
- Patients undergoing chemo and radiotherapy.
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 |
|---|---|---|
| Roxolid implantsAlso: Straumann BLX® SLA implantsfour Straumann BLX® roxolid implant 15% zirconium and 85% titanium), 3.7 mm in diameter, and 10 mm in length.implants were selected with the following criteria: tapered, self-tapping, aggressively threaded,were inserted with novalock attachments. | Device | Group( A) ROXOLID IMPLANT |
| Titanium implantsAlso: JD EVOLUTION PLUS implantsfour conventional acid etched pure implants tapered, self-tapping, threaded, two-piece, with the 10 mm length and 3.7 mm diameter were inserted with Sphero flex attachments. | Device | Group (B) CONVENTIONAL TITANIUM IMPLANT |
Primary outcome
measuring primary at time of surgery
Time frame: same day of implant placement
using an Ostell device with a smart peg to measure primary stability at the time of implant placement and measuring secondary stability after six weeks of implant placement.
1 secondary outcome
secondary implant stability after 6 weeks
Time frame: 6 weeks
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 28 Mar 2024.
- Background: PubMed 35747499Pandey C, Rokaya D, Bhattarai BP. Contemporary Concepts in Osseointegration of Dental Implants: A Review. Biomed Res Int. 2022 Jun 14;2022:6170452. doi: 10.1155/2022/6170452. eCollection 2022.
- Background: PubMed 35686699Thanasrisuebwong P, Pimkhaokham A, Jirajariyavej B, Bencharit S. Influence of the Residual Ridge Widths and Implant Thread Designs on Implant Positioning Using Static Implant Guided Surgery. J Prosthodont. 2023 Apr;32(4):340-346. doi: 10.1111/jopr.13557. Epub 2022 Jun 22.
- Derived from this study: PubMed 39107737El-Hady AIA, Eid HI, Mohamed SL, Fadl SM. Influence of titanium and titanium-zirconium alloy as implant materials on implant stability of maxillary implant retained overdenture: a randomized clinical trial. BMC Oral Health. 2024 Aug 6;24(1):902. doi: 10.1186/s12903-024-04692-x.
- Individual participant dataSharing planned: Yes. THE PROTOCOL OF OUR STUDY THAT WILL BE SHARED
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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.
shaimaa L mohamed, PROFESSOR principal investigator
Ains hams univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roxolid implants and Titanium implants in people with Completely Edentulous Patients, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 5 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 28 Mar 2024. 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 Egypt. 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?
measuring primary at time of surgery (time frame: same day of implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334770, which also lists 3 linked publications.
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 28 Mar 2024.