Edentulous Alveolar Ridge In MandibleNCT07513155
"Retention and Quality of Life in Mandibular Overdentures Using Two Attachment Systems: A Randomized Clinical Trial"
A study testing OT-Equator Attachment and Novaloc Attachment in people with Edentulous Alveolar Ridge In Mandible and Complete Edentulism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This randomized clinical trial investigates the effect of two different attachment systems-Equator and Novaloc-on the retention, patient satisfaction, and oral health-related quality of life of mandibular implant overdentures. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, Dental Implant
- What is being tested?
- OT-Equator Attachment and Novaloc Attachment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Oct 2025
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients' ages must range from 60-70 years old.
- All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
- Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
- 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.
Egypt1 site
Oral and Dental Research Institute, National Research Center
Cairo, Cairo Governorate, 4470351
About this study
Official title: Effect of Using Two Different Attachments Supporting Mandibular Overdenture on Retention and Quality of Life (Randomized Clinical Trial)
This randomized clinical trial investigates the effect of two different attachment systems-Equator and Novaloc-on the retention, patient satisfaction, and oral health-related quality of life of mandibular implant overdentures. Completely edentulous patients often experience reduced denture stability, compromised chewing ability, and diminished oral function with conventional complete dentures. Implant-retained overdentures have been shown to improve retention, stability, and overall patient satisfaction. Equator attachments offer a small, resilient, and self-aligning system with variable retention levels, while Novaloc attachments feature innovative PEEK caps and a diamond-like carbon coating designed to reduce wear and maintain long-term retention. This study aims to determine whether one attachment system provides superior functional outcomes and patient-centered benefits, thereby guiding clinicians in optimizing overdenture therapy for edentulous patients."
Read the detailed description
All 26 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 randomly divided into two equal groups; Group I will be retained by Novaloc attachment. While, Group II will be retained by Equator attachment. Implants will be functionally loaded after three months of insertion.
Retention of lower denture will be measured using digital force gauge, Oral health quality of life will be measured by verbal The Oral Health Impact Profile (OHIP) questionnaire. Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 6 month, and 12 month later.
- Conditions
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, Dental Implant, Implant Retained Overdenture, Attachment
- Being tested
- OT-Equator Attachment, Novaloc Attachment
- Keywords
- Dental Implants, Attachments, Edentulous Ridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-Equator AttachmentProcedure or surgery
Two implants will be restored using OT attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing
Novaloc AttachmentProcedure or surgery
Two implants will be restored using Novaloc attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing
| Study group | Role | What they receive |
|---|---|---|
| OT-Equator Attachment | Active comparator | On the 2nd Stage, implants will be loaded with OT-Equator Attachment to retain overdenture Receives: Procedure: OT-Equator Attachment |
| Novaloc Attachment | Experimental | On the 2nd Stage, implants will be loaded with Novaloc Attachment to retain overdenture Receives: Procedure: Novaloc Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
it will be measured using digital force gauge
Measured: It will be measured at denture insertion, 6 months and 12 months
Secondary outcomes (2)
The Oral Health Impact Profile (OHIP) questionnaire
It is one of the most technically sophisticated instruments used for assessment of OHRQoL. The OHIP was developed and validated by Slade and Spencer and several versions of the tool have been developed thereafter. Among the available short versions, the OHIP-EDENT has been deemed the most appropriate tool for the edentulous patients, as it presented a set of specific questions. The tool detects the impact of oral health on the quality of life of patients with implant supported overdenture prosthesis, before and after they have received them.
Measured: It will be measured at denture insertion, 6 months and 12 months
Patient Satisfaction
Patient satisfaction was evaluated with a standard 5-point Likert scale questionnaire, which included subjective parameters such as initial adaptability, post insertion problems, aesthetics, masticatory ability, speech, retention. Patients were asked to respond to question given in the questionnaire
Measured: it will be measured at denture insertion, 6 month, and 12 month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Apr 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge In MandibleStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Taha Kamel Taha Alloush, Misr International University
- Investigators
- Noha T Alloush, Lecturer, Principal investigator, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513155
- Sponsor's protocol ID
- 03411225
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Two Different Attachments Supporting Mandibular Overdenture on Retention and Quality of Life (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07513155
- Acronym / sponsor ID
- 03411225
- Conditions
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, Dental Implant, Implant Retained Overdenture, Attachment
- Keywords
- Dental Implants, Attachments, Edentulous Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 6 Apr 2026 (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.
This randomized clinical trial investigates the effect of two different attachment systems-Equator and Novaloc-on the retention, patient satisfaction, and oral health-related quality of life of mandibular implant overdentures. Completely edentulous patients often experience reduced denture stability, compromised chewing ability, and diminished oral function with conventional complete dentures. Implant-retained overdentures have been shown to improve retention, stability, and overall patient satisfaction. Equator attachments offer a small, resilient, and self-aligning system with variable retention levels, while Novaloc attachments feature innovative PEEK caps and a diamond-like carbon coating designed to reduce wear and maintain long-term retention. This study aims to determine whether one attachment system provides superior functional outcomes and patient-centered benefits, thereby guiding clinicians in optimizing overdenture therapy for edentulous patients."
Detailed description
All 26 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 randomly divided into two equal groups; Group I will be retained by Novaloc attachment. While, Group II will be retained by Equator attachment. Implants will be functionally loaded after three months of insertion.
Retention of lower denture will be measured using digital force gauge, Oral health quality of life will be measured by verbal The Oral Health Impact Profile (OHIP) questionnaire. Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 6 month, and 12 month later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT-Equator Attachment | Active comparator | Procedure: OT-Equator AttachmentOn the 2nd Stage, implants will be loaded with OT-Equator Attachment to retain overdenture |
| Novaloc Attachment | Experimental | Procedure: Novaloc AttachmentOn the 2nd Stage, implants will be loaded with Novaloc Attachment to retain overdenture |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients' ages must range from 60-70 years old.
- All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
- Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
- 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 |
|---|---|---|
| OT-Equator AttachmentTwo implants will be restored using OT attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing | Procedure or surgery | OT-Equator Attachment |
| Novaloc AttachmentTwo implants will be restored using Novaloc attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing | Procedure or surgery | Novaloc Attachment |
Primary outcome
Retention
Time frame: It will be measured at denture insertion, 6 months and 12 months
it will be measured using digital force gauge
2 secondary outcomes
The Oral Health Impact Profile (OHIP) questionnaire
Time frame: It will be measured at denture insertion, 6 months and 12 months
Patient Satisfaction
Time frame: it will be measured at denture insertion, 6 month, and 12 month later.
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 6 Apr 2026.
- Individual participant dataSharing planned: Yes. Study Protocol and Clinical Study Report
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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.
Noha T Alloush, Lecturer principal investigator
Misr International 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 OT-Equator Attachment and Novaloc Attachment in people with Edentulous Alveolar Ridge In Mandible and Complete 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 4 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: finished, as of the sponsor's last update on 6 Apr 2026. 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?
Retention (time frame: It will be measured at denture insertion, 6 months and 12 months). 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 Apr 2026.