Denture RetentionNCT04991064
Retention of Maxillary Complete Dentures Modified With Titanium Dioxide Nanoparticles: A Randomized Crossover Clinical Trial.
A study testing Complete denture base modified by Titanium dioxide nanoparticles. in people with Denture Retention and Complete Dentures, run by Cairo University at 1 site in Egypt.
Trial summary
This study investigates the effect of the addition of titanium dioxide nanoparticles to denture base materials on their retention compared to that of the unmodified denture base materials. Read more about this study
- Who is it for?
- Ages 45 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture Retention, Complete Dentures
- What is being tested?
- Complete denture base modified by Titanium dioxide nanoparticles.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2017to 15 Jun 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients requiring new removable complete dentures, with class I edentulous arches based on the American College of Prosthodontists (ACP) classification15, with an average age of 45-55 years old, with healthy temporomandibular joint, being without systemic disease that could affect the neuromuscular control or salivary flow
Who cannot join
- Patients with ACP Class II, III, or IV, and xerostomia.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effect of the addition of titanium dioxide nanoparticles to denture base materials on their retention compared to that of the unmodified denture base materials.
Read the detailed description
All patients will be randomly allocated to two equal groups either with the protocol I or II (5 in each group) with an allocation ratio of 1:1 through a computer-generated sequence by a spreadsheet (Excel, Microsoft Office 2010; Microsoft Corp). The group with the protocol I will use the modified dentures with titanium dioxide nanoparticles (TiO2NP) during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the unmodified dentures for 1 month; the group with the protocol II will use the unmodified dentures during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the modified dentures TiO2NP for 1 month. Assessment of retention will be done immediately and 1 month after denture insertion.
- Conditions
- Denture Retention, Complete Dentures
- Being tested
- Complete denture base modified by Titanium dioxide nanoparticles.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete denture base modified by Titanium dioxide nanoparticles.Other
Titanium dioxide nanoparticles will be mixed with resin powder of the denture base before mixing the powder and liquid of the heat cure denture base material.
| Study group | Role | What they receive |
|---|---|---|
| AB arm | Other | participants allocated to this arm receive treatment A first, followed by treatment B. Receives: Other: Complete denture base modified by Titanium dioxide nanoparticles. |
| BA arm | Other | participants allocated to this arm receive treatment B first, followed by treatment A. Receives: Other: Complete denture base modified by Titanium dioxide nanoparticles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the change in the retention within each type of complete denture.
It is measured in Newton.
Measured: Assessment will be done Immediately and 1 month after denture insertion within each type of denture.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start12 Feb 2017
- Primary completion3 Jun 2017
- Study completion15 Jun 2017
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.
- More trials run by Cairo 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gamal Ismail Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991064
- Sponsor's protocol ID
- 38912240102212
- Status last verified
- Sep 2021
- First submitted
- 17 Jul 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the co-author has the IPD. He is responsible to store it in an inaccessible place for anyone.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of Maxillary Complete Dentures Modified With Titanium Dioxide Nanoparticles: A Randomized Crossover Clinical Trial.
- ClinicalTrials.gov ID
- NCT04991064
- Acronym / sponsor ID
- 38912240102212
- Conditions
- Denture Retention, Complete Dentures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2017 (actual)
- Primary completion
- 3 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 5 Aug 2021 (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 investigates the effect of the addition of titanium dioxide nanoparticles to denture base materials on their retention compared to that of the unmodified denture base materials.
Detailed description
All patients will be randomly allocated to two equal groups either with the protocol I or II (5 in each group) with an allocation ratio of 1:1 through a computer-generated sequence by a spreadsheet (Excel, Microsoft Office 2010; Microsoft Corp). The group with the protocol I will use the modified dentures with titanium dioxide nanoparticles (TiO2NP) during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the unmodified dentures for 1 month; the group with the protocol II will use the unmodified dentures during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the modified dentures TiO2NP for 1 month. Assessment of retention will be done immediately and 1 month after denture insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB arm | Other | Other: Complete denture base modified by Titanium dioxide nanoparticles.participants allocated to this arm receive treatment A first, followed by treatment B. |
| BA arm | Other | Other: Complete denture base modified by Titanium dioxide nanoparticles.participants allocated to this arm receive treatment B first, followed by treatment A. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients requiring new removable complete dentures, with class I edentulous arches based on the American College of Prosthodontists (ACP) classification15, with an average age of 45-55 years old, with healthy temporomandibular joint, being without systemic disease that could affect the neuromuscular control or salivary flow
Key exclusion criteria (1 listed)
- Patients with ACP Class II, III, or IV, and xerostomia.
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 |
|---|---|---|
| Complete denture base modified by Titanium dioxide nanoparticles.Titanium dioxide nanoparticles will be mixed with resin powder of the denture base before mixing the powder and liquid of the heat cure denture base material. | Other | AB arm, BA arm |
Primary outcome
Assessment of the change in the retention within each type of complete denture.
Time frame: Assessment will be done Immediately and 1 month after denture insertion within each type of denture.
It is measured in Newton.
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 20 Sep 2021.
- Individual participant dataSharing planned: No. Only the co-author has the IPD. He is responsible to store it in an inaccessible place for anyone.
Related trials for Denture Retention
Not yet recruiting
Comparing Impression Techniques for Maxillary Complete Denture Retention
Denture Retention, Patient Satisfaction
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 Complete denture base modified by Titanium dioxide nanoparticles. in people with Denture Retention and Complete Dentures, run by Cairo 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 1 inclusion and 1 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 20 Sep 2021. 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?
Assessment of the change in the retention within each type of complete denture. (time frame: Assessment will be done Immediately and 1 month after denture insertion within each type of denture.). 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 20 Sep 2021; AzTrials last refreshed its copy on 3 Nov 2026.