Completely Edentulous MaxillaNCT06011031
Assessment of Novaloc and Locator Attachment Systems
A study testing Novaloc attachment and Locator attachment in people with Completely Edentulous Maxilla, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the current study is to assess the effect of two types of attachments (Locator, Novaloc) on the supporting structures both mechanically using stress strain analysis and biologically through measuring bone height using cbct. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Completely Edentulous Maxilla
- What is being tested?
- Novaloc attachment and Locator attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2021to 5 Dec 2024
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patient with u shaped dental arch.
- Systemically free.
- Patients completed all extraction at least 6 months before surgery.
- Patients Tempromandibular joint is free from any disease.
- Patient's mouth opening is proper for accessibility during surgery and implant placement.
- Sufficient bone level (length, and width) at implant placement site.
- Presence of enough bone height at implant site close to the maxillary sinus.
- Absence of sinus pneumatization.
Who cannot join
- Heavy smoker.
- Patients with bone diseases.
- Patients having a history of parafunctional habits.
- Patients with diabetes mellitus.
- Patients on chemotherapy or radiotherapy.
- Patients on any medications that reduce wound healing.
- Patients without sufficient bone level (height, width).
- Patients with sinus pneumatization.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Prosthodontics Department Faculty of Dentistry Ain Shams University
Cairo, 11591
About this study
Official title: Mechanical and Biological Assessment of Two Different Attachment Materials in Maxillary Implant Retained Overdenture In-Vivo Study
The aim of the current study is to assess the effect of two types of attachments (Locator, Novaloc) on the supporting structures both mechanically using stress strain analysis and biologically through measuring bone height using cbct.
Read the detailed description
14 Completely edentulous patients will be divided into two groups each group contains seven patients: Group One: Each patient will be restored with 4 implant retained maxillary overdenture using Peek retention inserts attachment system and Bone Level Ti-Zr implants.
Group Two: Each patient will be restored with 4 implant retained maxillary overdenture using Nylon retention insert attachment system and Bone Level Ti implants.
Bone height in millimeters will then be evaluated around each implant using cone beam computed tomography at the time of placement of attachments, 6 months, 1 year
- Conditions
- Completely Edentulous Maxilla
- Being tested
- Novaloc attachment, Locator attachment
- Keywords
- implant overdenture, maxilla, novaloc, locator, peek
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novaloc attachmentDevice
Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
Locator attachmentDevice
Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
| Study group | Role | What they receive |
|---|---|---|
| Novaloc attachment | Experimental | a newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon. Receives: Device: Novaloc attachment |
| locator attachment | Active comparator | a device with low-profile attachment used in cases of limited inter arch distance, provides excellent retention, possesses a self-aligning property and allow correction of implant divergence up to 20 degrees Receives: Device: Locator attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone level change around implants
measurement of bone height mesial, distal to each implant
Measured: Through study completion an average 1 year.
Secondary outcomes (1)
patient satisfaction
Patient satisfaction was evaluated using a questionnaire based on the visual analog scale (VAS). Patients were asked to mark their answers (amount of satisfaction). The questionnaire was given to the patients in Arabic.Six factors were rated on a 1 to 5 scale (highly satisfied = 5; satisfied = 4; fair = 3; dissatisfied = 2; highly dissatisfied = 1). The sum of the five sub-scores was then calculated, ranging from 5 to 30 (best score = 30, worst score = 5). The low range of scores indicated low satisfaction.
Measured: Through study completion an average 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start5 Jun 2021
- Primary completion5 Dec 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely Edentulous MaxillaStudies 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
- Model description
- This is a Randomized Clinical Trial (phase IV) as it will compare two types of attachment systems (a new one with an old one), assess the effects of both types, and state which one is better.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hany Ibrahim Eid, Prof, Study director, Ain Shams UniversityNoha Helmy Nawwar, Prof, Study director, Ain Shams UniversityAhmed Mohamed Osama, Prof, Study director, Ain Shams UniversityFatma Fouad Sadek, AssistantLec, Principal investigator, Egyptian Russian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011031
- Sponsor's protocol ID
- FDASU- Rec ID 032117
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: once all data is collected, sharing of Study Protocol,Statistical Analysis Plan (SAP),Clinical Study Report (CSR) will be done
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical and Biological Assessment of Two Different Attachment Materials in Maxillary Implant Retained Overdenture In-Vivo Study
- ClinicalTrials.gov ID
- NCT06011031
- Acronym / sponsor ID
- FDASU- Rec ID 032117
- Conditions
- Completely Edentulous Maxilla
- Keywords
- implant overdenture, maxilla, novaloc, locator, peek
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 25 Aug 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 of the current study is to assess the effect of two types of attachments (Locator, Novaloc) on the supporting structures both mechanically using stress strain analysis and biologically through measuring bone height using cbct.
Detailed description
14 Completely edentulous patients will be divided into two groups each group contains seven patients: Group One: Each patient will be restored with 4 implant retained maxillary overdenture using Peek retention inserts attachment system and Bone Level Ti-Zr implants.
Group Two: Each patient will be restored with 4 implant retained maxillary overdenture using Nylon retention insert attachment system and Bone Level Ti implants.
Bone height in millimeters will then be evaluated around each implant using cone beam computed tomography at the time of placement of attachments, 6 months, 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a Randomized Clinical Trial (phase IV) as it will compare two types of attachment systems (a new one with an old one), assess the effects of both types, and state which one is better.
| Arm | Type | Receives |
|---|---|---|
| Novaloc attachment | Experimental | Device: Novaloc attachmenta newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon. |
| locator attachment | Active comparator | Device: Locator attachmenta device with low-profile attachment used in cases of limited inter arch distance, provides excellent retention, possesses a self-aligning property and allow correction of implant divergence up to 20 degrees |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Completely edentulous patient with u shaped dental arch.
- Systemically free.
- Patients completed all extraction at least 6 months before surgery.
- Patients Tempromandibular joint is free from any disease.
- Patient's mouth opening is proper for accessibility during surgery and implant placement.
Key exclusion criteria (8 listed)
- Heavy smoker.
- Patients with bone diseases.
- Patients having a history of parafunctional habits.
- Patients with diabetes mellitus.
- Patients on chemotherapy or 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 |
|---|---|---|
| Novaloc attachmentEach patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment | Device | Novaloc attachment |
| Locator attachmentEach patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment | Device | locator attachment |
Primary outcome
bone level change around implants
Time frame: Through study completion an average 1 year.
measurement of bone height mesial, distal to each implant
1 secondary outcome
patient satisfaction
Time frame: Through study completion an average 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Yes. once all data is collected, sharing of Study Protocol,Statistical Analysis Plan (SAP),Clinical Study Report (CSR) will be done
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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.
Hany Ibrahim Eid, Prof study director
Ain Shams University
Noha Helmy Nawwar, Prof study director
Ain Shams University
Ahmed Mohamed Osama, Prof study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novaloc attachment and Locator attachment in people with Completely Edentulous Maxilla, 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 8 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: status not confirmed, as of the sponsor's last update on 1 Feb 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?
Results are not available in the source record.
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?
bone level change around implants (time frame: Through study completion an average 1 year.). 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 1 Feb 2024.