Missing Posterior Occlusal ContactNCT04554199
Brain and Cognitive Function of Patients With RPD
A study testing Flexible partial denture in people with Missing Posterior Occlusal Contact, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
To evaluate the influence of restoring lost posterior occlusal contacts with removable partial denture (RPD) on the brain activity and cognitive function in controlled type 2 diabetic patients Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Missing Posterior Occlusal Contact
- What is being tested?
- Flexible partial denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jul 2019
- 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 40 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Loss of posterior occlusal contact unilaterally or bilaterally in both maxilla and mandible.
- No previous partial dentures experience.
- Nonsmokers.
- Skeletally Angle's class I.
- Controlled type 2 diabetes.
Who cannot join
- History of brain diseases (e.g. cerebral infarction, and Alzheimer's).
- Neuromuscular disorders.
- Temporomandibular joint disorder.
- Psychiatric illness.
- Participants with parafunctional oral habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Changes in Brain Activity and Cognitive Function of Diabetic Patients Wearing Removable Partial Dentures
To evaluate the influence of restoring lost posterior occlusal contacts with removable partial denture (RPD) on the brain activity and cognitive function in controlled type 2 diabetic patients
- Conditions
- Missing Posterior Occlusal Contact
- Being tested
- Flexible partial denture
- Keywords
- Removable partial dentures, Electro-encephalogram, Mini mental state examination, Controlled type 2 diabetes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible partial dentureDevice
removable partial dentures (RPDs) were fabricated using thermoplastic resins (flexible RPDs). EEG and MMSE were evaluated before denture delivery and after one month of denture wear.
| Study group | Role | What they receive |
|---|---|---|
| EEG and MMSE measurements before receiving RPD | Experimental | EEG and MMSE were measured for all participant before wearing the removable partial dentures. Receives: Device: Flexible partial denture |
| EEG and MMSE measurements after receiving RPD | Experimental | EEG and MMSE were measured for all participant after wearing the removable partial dentures Receives: Device: Flexible partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity measurement in controlled type 2 diabetic patients wearing RPD.
RPDs were fabricated for each participant using thermoplastic resin. The brain activity was assessed using EEG by measuring the alpha waves (Dα/Hz) in controlled type 2 diabetic patients wearing RPDs. EEG records were obtained before denture delivery and one month after denture wear.
Measured: For each participant the RPD should be worn for one month.
Cognitive function assessment in controlled type 2 diabetic patients wearing RPD.
For the same participates the cognitive function was assessed via MMSE questionnaire. MMSE consists of 12 questions with maximum scoring of 30. The measurements were obtained before denture delivery and one month after denture wear.
Measured: For each participant the RPD should be worn for one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Jan 2019
- Primary completion1 May 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing Posterior Occlusal ContactStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nabil Elboraey, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554199
- Sponsor's protocol ID
- 16-086
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2020
- Last updated
- 18 Sep 2020
- 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 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Brain Activity and Cognitive Function of Diabetic Patients Wearing Removable Partial Dentures
- ClinicalTrials.gov ID
- NCT04554199
- Acronym / sponsor ID
- 16-086
- Conditions
- Missing Posterior Occlusal Contact
- Keywords
- Removable partial dentures, Electro-encephalogram, Mini mental state examination, Controlled type 2 diabetes.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 18 Sep 2020 (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.
To evaluate the influence of restoring lost posterior occlusal contacts with removable partial denture (RPD) on the brain activity and cognitive function in controlled type 2 diabetic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG and MMSE measurements before receiving RPD | Experimental | Device: Flexible partial dentureEEG and MMSE were measured for all participant before wearing the removable partial dentures. |
| EEG and MMSE measurements after receiving RPD | Experimental | Device: Flexible partial dentureEEG and MMSE were measured for all participant after wearing the removable partial dentures |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Loss of posterior occlusal contact unilaterally or bilaterally in both maxilla and mandible.
- No previous partial dentures experience.
- Nonsmokers.
- Skeletally Angle's class I.
- Controlled type 2 diabetes.
Key exclusion criteria (5 listed)
- History of brain diseases (e.g. cerebral infarction, and Alzheimer's).
- Neuromuscular disorders.
- Temporomandibular joint disorder.
- Psychiatric illness.
- Participants with parafunctional oral habits.
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 |
|---|---|---|
| Flexible partial dentureremovable partial dentures (RPDs) were fabricated using thermoplastic resins (flexible RPDs). EEG and MMSE were evaluated before denture delivery and after one month of denture wear. | Device | EEG and MMSE measurements after receiving RPD, EEG and MMSE measurements before receiving RPD |
Primary outcome
Brain activity measurement in controlled type 2 diabetic patients wearing RPD.
Time frame: For each participant the RPD should be worn for one month.
RPDs were fabricated for each participant using thermoplastic resin. The brain activity was assessed using EEG by measuring the alpha waves (Dα/Hz) in controlled type 2 diabetic patients wearing RPDs. EEG records were obtained before denture delivery and one month after denture wear.
Cognitive function assessment in controlled type 2 diabetic patients wearing RPD.
Time frame: For each participant the RPD should be worn for one month.
For the same participates the cognitive function was assessed via MMSE questionnaire. MMSE consists of 12 questions with maximum scoring of 30. The measurements were obtained before denture delivery and one month after denture wear.
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 18 Sep 2020.
- Individual participant dataSharing planned: No
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 Flexible partial denture in people with Missing Posterior Occlusal Contact, run by National Research Centre, Egypt 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 5 inclusion and 5 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 18 Sep 2020. 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?
Brain activity measurement in controlled type 2 diabetic patients wearing RPD. (time frame: For each participant the RPD should be worn for one month.). 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 18 Sep 2020.