SwallowingNCT06795295
Swallowing Dynamic of Implant Retained Mandibular Overdentures
A study testing Implant retained mandibular overdenture in people with Swallowing, run by Mansoura University at 1 site in Egypt.
Trial summary
This Randomized clinical study was conducted to compare between two-implant versus single implant-retained mandibular overdenture regarding swallowing dynamic using The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST) Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Swallowing
- What is being tested?
- Implant retained mandibular overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Sep 2023to 20 Dec 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Free from any systemic disease.
- Free from any medical or surgical conditions that cause dysphagia (swallowing problems).
- A sufficient residual alveolar bone quantity (height and width). This was verified by a CT scan using cone-beam computed tomography for each patient.
- All patients had sufficient bone either D2 or D3 by measuring the Hounsfield unit on CBCT scan.
- Residual ridges are covered by firm healthy mucosa.
- Class I maxilla-mandibular relationship.
- sufficient inter-arch space and restorative space for locator retained mandibular overdenture.
Who cannot join
- Patient with absolute contraindications for implant placement such as active cancer, immunosuppression, bleeding issues, and metabolic diseases that directly affect the bone such as osteoporosis, and hyperparathyroidism.
- Patients with relative contraindication: history of para functional habits such as bruxism, clenching, and bad habits such as smoking and alcoholism, uncontrolled diabetic patients.
- Patients with local contraindications for implant placement due to localized bone defects.
- Non-cooperative patients who don't follow instructions during and after the operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swallowing Dynamic of Two Implant Versus Single Implant Retained Mandibular Overdentures
This Randomized clinical study was conducted to compare between two-implant versus single implant-retained mandibular overdenture regarding swallowing dynamic using The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST)
Read the detailed description
There are lack of studies comparing single and two implant-retained mandibular overdentures regarding swallowing dynamic. This Randomized clinical study aimed to compare the effect of two treatment modalities of mandibular implant over denture on the swallowing dynamic.
8 completely edentulous patients were selected from the Out-Patient Clinic of Prosthodontics' Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation. All patients were randomly distributed into two equal groups; Group I (Patients received two-implant mandibular overdenture with locator attachment) and Group II ( Patients received single implant mandibular overdenture with locator attachment) All subjects received a newly carefully constructed complete dentures and then the lower dentures were changed into mandibular implant retained overdentures using locator attachments by placing two implants on the mandibular canine regions for group I and single midline implant for group II.
Swallowing dynamic was evaluated after 3 months of complete denture insertion for both groups. After mandibular overdenture insertion swallowing dynamic was evaluated 2 weeks after insertion and three months after overdenture insertion for both groups.
- Conditions
- Swallowing
- Being tested
- Implant retained mandibular overdenture
- Keywords
- swallowing dynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant retained mandibular overdentureProcedure or surgery
Also called BTK implant
Participants received dental implants to retain mandibular overdentures.
| Study group | Role | What they receive |
|---|---|---|
| Group І 2- IMOVD | Active comparator | Patients received two implant on the mandibular canine regions to retain mandibular overdenture with locator attachment Receives: Procedure: Implant retained mandibular overdenture |
| Group ІІ 1-IMOVD | Active comparator | Patients received single mandibular midline implant to retain mandibular overdenture with locator attachment Receives: Procedure: Implant retained mandibular overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures
Evaluation of swallowing dynamic of both groups was done by The Test of Mastication and Swallowing Solids (TOMASS) to measure (number of swallows,number of chews,and total time)
Measured: The evaluation of swallowing by TOMASS for(no swallows, no of chews,and total time)was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.
Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures
swallowing dynamic of both groups was evaluated by the Timed Water Swallow Test (TWST) to measure (time per swallow, volume per swallow,and swallowing capcity)
Measured: The evaluation of swallowing by TWST for (time per swallow, volume per swallow, and swallowing capcity) was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start18 Sep 2023
- Primary completion18 Sep 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SwallowingStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Taha Abdo El_Baz, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795295
- Sponsor's protocol ID
- A05011122
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 28 Jan 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swallowing Dynamic of Two Implant Versus Single Implant Retained Mandibular Overdentures
- ClinicalTrials.gov ID
- NCT06795295
- Acronym / sponsor ID
- A05011122
- Conditions
- Swallowing
- Keywords
- swallowing dynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 28 Jan 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 Randomized clinical study was conducted to compare between two-implant versus single implant-retained mandibular overdenture regarding swallowing dynamic using The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST)
Detailed description
There are lack of studies comparing single and two implant-retained mandibular overdentures regarding swallowing dynamic. This Randomized clinical study aimed to compare the effect of two treatment modalities of mandibular implant over denture on the swallowing dynamic.
8 completely edentulous patients were selected from the Out-Patient Clinic of Prosthodontics' Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation. All patients were randomly distributed into two equal groups; Group I (Patients received two-implant mandibular overdenture with locator attachment) and Group II ( Patients received single implant mandibular overdenture with locator attachment) All subjects received a newly carefully constructed complete dentures and then the lower dentures were changed into mandibular implant retained overdentures using locator attachments by placing two implants on the mandibular canine regions for group I and single midline implant for group II.
Swallowing dynamic was evaluated after 3 months of complete denture insertion for both groups. After mandibular overdenture insertion swallowing dynamic was evaluated 2 weeks after insertion and three months after overdenture insertion for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group І 2- IMOVD | Active comparator | Procedure: Implant retained mandibular overdenturePatients received two implant on the mandibular canine regions to retain mandibular overdenture with locator attachment |
| Group ІІ 1-IMOVD | Active comparator | Procedure: Implant retained mandibular overdenturePatients received single mandibular midline implant to retain mandibular overdenture with locator attachment |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Free from any systemic disease.
- Free from any medical or surgical conditions that cause dysphagia (swallowing problems).
- A sufficient residual alveolar bone quantity (height and width). This was verified by a CT scan using cone-beam computed tomography for each patient.
- All patients had sufficient bone either D2 or D3 by measuring the Hounsfield unit on CBCT scan.
- Residual ridges are covered by firm healthy mucosa.
Key exclusion criteria (4 listed)
- Patient with absolute contraindications for implant placement such as active cancer, immunosuppression, bleeding issues, and metabolic diseases that directly affect the bone such as osteoporosis, and hyperparathyroidism.
- Patients with relative contraindication: history of para functional habits such as bruxism, clenching, and bad habits such as smoking and alcoholism, uncontrolled diabetic patients.
- Patients with local contraindications for implant placement due to localized bone defects.
- Non-cooperative patients who don't follow instructions during and after the operation.
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 |
|---|---|---|
| Implant retained mandibular overdentureAlso: BTK implantParticipants received dental implants to retain mandibular overdentures. | Procedure or surgery | Group І 2- IMOVD, Group ІІ 1-IMOVD |
Primary outcome
Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures
Time frame: The evaluation of swallowing by TOMASS for(no swallows, no of chews,and total time)was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.
Evaluation of swallowing dynamic of both groups was done by The Test of Mastication and Swallowing Solids (TOMASS) to measure (number of swallows,number of chews,and total time)
Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures
Time frame: The evaluation of swallowing by TWST for (time per swallow, volume per swallow, and swallowing capcity) was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.
swallowing dynamic of both groups was evaluated by the Timed Water Swallow Test (TWST) to measure (time per swallow, volume per swallow,and swallowing capcity)
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 28 Jan 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 Implant retained mandibular overdenture in people with Swallowing, run by Mansoura 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 4 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 28 Jan 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?
Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures (time frame: The evaluation of swallowing by TOMASS for(no swallows, no of chews,and total time)was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.). 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 28 Jan 2025.