Edentulism in Lower JawOverdentureNCT06721377
Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.
A study testing Novaloc attachment and Equator attachment in people with Edentulism in Lower Jaw and Edentulism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Patients will be selected from the outpatient clinic of Removable Prosthodontic Department. Faculty of Dental Medicine for Girls, Al-Azhar University.. Each patient will be assessed for eligibility and Informed consent will be obtained from patient after explanation of the treatment protocols and expected outcomes or… Read more about this study
- Who is it for?
- Ages 65 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulism in Lower Jaw, Edentulism
- What is being tested?
- Novaloc attachment and Equator attachment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 69 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
- Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
- All patients must have sufficient inter arch space.
Who cannot join
- Patients with oral or systemic diseases.
- Patients with xerostomia or excessive salivation.
- Patients with parafunctional habits (bruxism or clenching).
- Heavy smoker or alcoholic patients.
- Patients with history of temporo-mandibular dysfunction.
- Patients with brain disorders or psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine , Al Azhar Univeristy For Girls
Cairo, Nasr City - Cairo, 123456
Sara H Kadry, Masters, 02-01226595217, sarra.kadry@miuegypt.edu.eg
zainab H Abdel rahman, Phd, 02-01221334637, zainab_hafez_87@hotmail.com
About this study
Official title: Clinical and Radiographic Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.
Patients will be selected from the outpatient clinic of Removable Prosthodontic Department. Faculty of Dental Medicine for Girls, Al-Azhar University..
Each patient will be assessed for eligibility and Informed consent will be obtained from patient after explanation of the treatment protocols and expected outcomes or alternative management.
Read the detailed description
All 10 patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two groups, one group will be loaded by Novaloc attachment. While the other group will be loaded by Equator attachment. Implants will be functionally loaded after three months of insertion.
- Conditions
- Edentulism in Lower Jaw, Edentulism
- Being tested
- Novaloc attachment, Equator attachment
- Keywords
- overdenture, implant placemnent, Novaloc attachment., Equator attachment, edentulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novaloc attachmentProcedure or surgery
upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region \& will be loaded by Novaloc attachment.
Equator attachmentProcedure or surgery
upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region\& will be loaded by Equator attachment.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Equator attachment Receives: Procedure: Novaloc attachment |
| study | Experimental | Novaloc attachment Receives: Procedure: Equator attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation of bone height
Radiographic evaluation of bone height around each implant and at distal extension area will be evaluated using cone beam CT (CBCT)
Measured: at baseline, 6 and 12 months
Radiographic evaluation of bone density
Radiographic evaluation of bone density around implant and at distal extension area will be evaluated using cone beam CT (CBCT)
Measured: at baseline, 6 and 12 months
Secondary outcomes (1)
Pocket depth
Pocket depth will be measured using periodontal probe
Measured: at baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2024
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism in Lower JawStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Hossam El-din Kadry Othman, Al-Azhar University
- Investigators
- sara H kadry, masters, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721377
- Sponsor's protocol ID
- REC al azhar university
- Acronym
- Overdenture
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.
- ClinicalTrials.gov ID
- NCT06721377
- Acronym / sponsor ID
- Overdenture / REC al azhar university
- Conditions
- Edentulism in Lower Jaw, Edentulism
- Keywords
- overdenture, implant placemnent, Novaloc attachment., Equator attachment, edentulism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 6 Dec 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.
Patients will be selected from the outpatient clinic of Removable Prosthodontic Department. Faculty of Dental Medicine for Girls, Al-Azhar University..
Each patient will be assessed for eligibility and Informed consent will be obtained from patient after explanation of the treatment protocols and expected outcomes or alternative management.
Detailed description
All 10 patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two groups, one group will be loaded by Novaloc attachment. While the other group will be loaded by Equator attachment. Implants will be functionally loaded after three months of insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Procedure: Novaloc attachmentEquator attachment |
| study | Experimental | Procedure: Equator attachmentNovaloc attachment |
Who may qualify
- Ages
- 65 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
- Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
- All patients must have sufficient inter arch space.
Key exclusion criteria (6 listed)
- Patients with oral or systemic diseases.
- Patients with xerostomia or excessive salivation.
- Patients with parafunctional habits (bruxism or clenching).
- Heavy smoker or alcoholic patients.
- Patients with history of temporo-mandibular dysfunction.
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 attachmentupper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region \& will be loaded by Novaloc attachment. | Procedure or surgery | control |
| Equator attachmentupper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region\& will be loaded by Equator attachment. | Procedure or surgery | study |
Primary outcome
Radiographic evaluation of bone height
Time frame: at baseline, 6 and 12 months
Radiographic evaluation of bone height around each implant and at distal extension area will be evaluated using cone beam CT (CBCT)
Radiographic evaluation of bone density
Time frame: at baseline, 6 and 12 months
Radiographic evaluation of bone density around implant and at distal extension area will be evaluated using cone beam CT (CBCT)
1 secondary outcome
Pocket depth
Time frame: at baseline, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- 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.
sara H kadry, masters principal investigator
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 Equator attachment in people with Edentulism in Lower Jaw and Edentulism, run by Al-Azhar 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara H Kadry, masters (02-01226595217, Sarra.kadry@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic evaluation of bone height (time frame: at baseline, 6 and 12 months). The study lists 2 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 6 Dec 2024.