Denture RetentionNCT06866067
The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture
A study testing PEEK clip and Nylon clip in people with Denture Retention, run by MTI University at 1 site in Egypt.
Trial summary
This study is aiming to evaluate the retention of implant supported mandibular overdenture using two different clip materials namely polyoxymethylene (POM) and poly-ether-ether-ketone (PEEK) on PEEK bar at three-time intervals; immediately after placement, after 3 months and after 6 months. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Denture Retention
- What is being tested?
- PEEK clip and Nylon clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Sep 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 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male.
- Completely edentulous.
- Age: 50-60 years.
- Free from any systemic diseases that affect bone metabolism.
- Good intraoral condition.
- Anterior mandibular bone height > 13mm and width > 5mm.
- The inter-arch space from 15mm to 17mm.
Who cannot join
- Smoking and drug abusing.
- Severe maxillomandibular skeletal discrepancy.
- Bone metabolic disorders.
- History of head and neck radiotherapy.
- Intravenous bisphosphonate therapy.
- Presence of para-functional habits.
- Temporomandibular joint disorders.
- Severe bony undercuts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture: Clinical Comparative Study
This study is aiming to evaluate the retention of implant supported mandibular overdenture using two different clip materials namely polyoxymethylene (POM) and poly-ether-ether-ketone (PEEK) on PEEK bar at three-time intervals; immediately after placement, after 3 months and after 6 months.
- Conditions
- Denture Retention
- Being tested
- PEEK clip, Nylon clip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK clipDevice
The overdentures were attached with PEEK clip . The retention of overdenture was assessed
Nylon clipDevice
The overdentures were attached with Nylon clip . The retention of overdenture was assessed
| Study group | Role | What they receive |
|---|---|---|
| PEEK clip | Other | Clip for overdenture retention made from poly-ether-ether-ketone (PEEK) Receives: Device: PEEK clip |
| Nylon clip | Other | Clip for overdenture retention made from nylon (C6H11NO)n Receives: Device: Nylon clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overdenture retention assessed using Universal Testing Machine (Newton)
Denture resistance corresponding to vertical displacement force was obtained using a universal testing machine (INSTRON, United States) to measure retention. Each patient had his chin securely fixed on a support while seated upright. The attachment portion of the universal machine was adjusted in accordance with the device's bar being securely attached to the denture. The device gradually increased the vertical load by 10 mm per minute until the denture completely fell out of place. A tuck sound can be heard to indicate the load at the dislodgment point. Additionally, the force plot in the recorded computer software data exhibits an abrupt drop (Nexyge; Lloyd Instruments; MT-4.6). Each test was repeated five times to obtain five records, and the mean of these records was calculated. Testing was carried out on the mandibular overdenture after insertion, as well as at 3 and 6 months.
Measured: From enrollment and after 3 months and finally at the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Feb 2024
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture RetentionStudies 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Medhat Mohamed Ali, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866067
- Sponsor's protocol ID
- 970/6525
- Status last verified
- Oct 2024
- First submitted
- 25 Feb 2025
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture: Clinical Comparative Study
- ClinicalTrials.gov ID
- NCT06866067
- Acronym / sponsor ID
- 970/6525
- Conditions
- Denture Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 10 Mar 2025 (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 study is aiming to evaluate the retention of implant supported mandibular overdenture using two different clip materials namely polyoxymethylene (POM) and poly-ether-ether-ketone (PEEK) on PEEK bar at three-time intervals; immediately after placement, after 3 months and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK clip | Other | Device: PEEK clipClip for overdenture retention made from poly-ether-ether-ketone (PEEK) |
| Nylon clip | Other | Device: Nylon clipClip for overdenture retention made from nylon (C6H11NO)n |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
Key exclusion criteria (8 listed)
- Smoking and drug abusing.
- Severe maxillomandibular skeletal discrepancy.
- Bone metabolic disorders.
- History of head and neck radiotherapy.
- Intravenous bisphosphonate therapy.
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 |
|---|---|---|
| PEEK clipThe overdentures were attached with PEEK clip . The retention of overdenture was assessed | Device | PEEK clip |
| Nylon clipThe overdentures were attached with Nylon clip . The retention of overdenture was assessed | Device | Nylon clip |
Primary outcome
Overdenture retention assessed using Universal Testing Machine (Newton)
Time frame: From enrollment and after 3 months and finally at the end of treatment at 6 months
Denture resistance corresponding to vertical displacement force was obtained using a universal testing machine (INSTRON, United States) to measure retention. Each patient had his chin securely fixed on a support while seated upright. The attachment portion of the universal machine was adjusted in accordance with the device's bar being securely attached to the denture. The device gradually increased the vertical load by 10 mm per minute until the denture completely fell out of place. A tuck sound can be heard to indicate the load at the dislodgment point. Additionally, the force plot in the recorded computer software data exhibits an abrupt drop (Nexyge; Lloyd Instruments; MT-4.6). Each test was repeated five times to obtain five records, and the mean of these records was calculated. Testing was carried out on the mandibular overdenture after insertion, as well as at 3 and 6 months.
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 10 Mar 2025.
- 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 PEEK clip and Nylon clip in people with Denture Retention, run by MTI 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 7 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 10 Mar 2025. 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?
Overdenture retention assessed using Universal Testing Machine (Newton) (time frame: From enrollment and after 3 months and finally at the end of treatment at 6 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 10 Mar 2025.