Prosthesis DurabilityNCT06705114
Ultrasound Investigation of Tongue Movement for Implant Overdenture
A study testing complete denture and implant overdenture in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to examine the impact of mandibular implant overdentures on tongue movement during mastication. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- complete denture and implant overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2023to 20 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients were completely edentulous for at least one year, had a normal maxillo-mandibular relationship, and had available inter-arch space. They were nonsmokers and free from any systemic diseases that could affect implant osseointegration
Who cannot join
- Patients with head and neck surgery, skeletal deformity, and temporomandibular joint disorder were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, mansoura university Mansoura, Egypt,
Al Mansurah, 35516
About this study
Official title: Ultrasound Investigation of Tongue Movement During Mastication for Completely Edentulous Patients Rehabilitated by Mandibular Implant Retained Overdenture
This study aimed to examine the impact of mandibular implant overdentures on tongue movement during mastication.
Read the detailed description
Each patient received a newly constructed conventional complete denture. To construct the radiographic stent, the mandibular denture was duplicated in clear acrylic resin and modified by placing multiple holes filled with radiopaque gutta-percha points. A stereolithographic surgical guide was then constructed using a dual scan technique with cone beam computerized tomography (CBCT, i-CAT Vision®, Imaging Sciences International, Hatfield, PA). Two dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol. Patients were instructed to rinse their mouth with Chlorohexidine mouthwash just before the implant surgery and continue for one week. A prophylactic antibiotic (Amoxicillin and Clavulanic acid 125 mg) was administered one hour before the surgery and continued for one week after surgery. To control pain, a nonsteroidal anti-inflammatory drug (Ibuprofen 600 mg) was prescribed. After surgery, patients were prohibited from using the complete denture and were advised to follow a soft diet.
After one week, the mandibular denture was relieved and relined with soft relining material (Softliner; PROMEDICA) and delivered to the patient. After 3-4 months, the dental implants were exposed and ball abutments were screwed into the implants (Fig.1A). The housing of the ball attachments were incorporated into the fitting surface of the mandibular denture using a direct pick-up technique (Fig. 1B). The mandibular overdenture was then inserted into the patient's mouth and occlusal adjustment was done using articulating paper to remove any occlusal interferences. Follow-up visits were scheduled.
Tongue movement measurement The evaluation of tongue movement was conducted using an ultrasound imaging system (Toshiba Medical Systems Corporation, Tokyo, Japan) with a 3.1-MHz convex probe. A layer of ultrasound jelly (Sono Jelly, Toshiba Medical Systems Corporation) was applied to the patient's skin under the probe. The patient was instructed to sit in upright position, and the probe was placed under the chin area to allow the beam to pass through the distal surfaces of the second premolars on both the right and left sides. The probe was secured in place using a microphone stand (Panasonic System Networks Co., Ltd., Tokyo, Japan) with adjustable height and angle. The position of the tongue was confirmed on the B-mode image of the sagittal plane, which provided a two-dimensional recording of the slice through the oral cavity. The recording rate was 0.0476 seconds (21 frames per second). Ultrasound images were taken while the patient chewed 1/4 of a cookie in a normal manner until it was swallowed.
The ultrasound images were taken at two different oral conditions: 3 months after complete denture insertion and 3 months after mandibular implant overdenture insertion. The ultrasound data were exported from the imaging system via a USB port and transferred to a personal computer. The Articulate Assistant Advanced (AAA) software program version 221.2.0 was used to analyze the data. The software program provides a measurement fan, which is used to automatically set control points at the intersection of the tongue-surface spline and each radial axis. This is done using the AAA edge-detection algorithm, which detects dark-bright discontinuities in the image. (28) The spline was then fitted to the visible surface of the tongue in each relevant video frame (Fig. 2). From the start time (the beginning of mastication) to the end time (when the tongue moved up towards the palate at the start of swallowing), the tongue surface was traced in AAA.
The following items were measured:
1 -Duration of Chewing: From time of food ingestion to the time of beginning of first swallowing.
2- Cumulative displacement of the tongue during Chewing: The distance (in mm) from the tongue surface spline to the anchor point (A) was measured along the radial fan lines at three different points: 30 degrees posterior (B), the center (C), and 30 degrees anterior (D) (Fig. 3). This measurement process was repeated for consecutive video frames. The sum of absolute change between consecutive frames for all measurement points was detected.
3- Tongue surface shape during chewing.
- Conditions
- Prosthesis Durability
- Being tested
- complete denture, implant overdenture
- Keywords
- Mastication, implant, mandibular, ultrasound, tongue movement
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete dentureProcedure or surgery
Each patient received a newly constructed conventional complete denture with optimal denture extension and lingualized balanced occlusal concept
implant overdentureProcedure or surgery
Two dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol.After 3-4 months, the dental implants were exposed and ball abutments were screwed into the implants. The housing of the ball attachments were incorporated into the fitting surface of the mandibular denture using a direct pick-up technique (Fig. 1B). The mandibular overdenture was then inserted into the patient's mouth and occlusal adjustment was done using articulating paper to remove any occlusal interferences. Follow-up visits were scheduled.
| Study group | Role | What they receive |
|---|---|---|
| group I: complete dentures | Active comparator | Each patient received a newly constructed conventional complete denture. Receives: Procedure: complete denture |
| group II: mandibular implant overdenture | Active comparator | Two dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol. Receives: Procedure: implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound investigation of tongue movement
The evaluation of tongue movement was conducted using an ultrasound imaging system (Toshiba Medical Systems Corporation, Tokyo, Japan) with a 3.1-MHz convex probe. A layer of ultrasound jelly (Sono Jelly, Toshiba Medical Systems Corporation) was applied to the patient's skin under the probe. The patient was instructed to sit in upright position, and the probe was placed under the chin area to allow the beam to pass through the distal surfaces of the second premolars on both the right and left sides. The probe was secured in place using a microphone stand (Panasonic System Networks Co., Ltd., Tokyo, Japan) with adjustable height and angle. The position of the tongue was confirmed on the B-mode image of the sagittal plane, which provided a two-dimensional recording of the slice through the oral cavity. The recording rate was 0.0476 seconds (21 frames per second). Ultrasound images were taken while the patient chewed 1/4 of a cookie in a normal manner until it was swallowed.
Measured: after 3 months of denture and overdenture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start20 Oct 2023
- Primary completion20 Jul 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis DurabilityStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705114
- Sponsor's protocol ID
- A01010023RP
- Status last verified
- Oct 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goncalves GSY, de Magalhaes KMF, Rocha EP, Dos Santos PH, Assuncao WG. Oral health-related quality of life and satisfaction in edentulous patients rehabilitated with implant-supported full dentures all-on-four concept: a systematic review. Clin Oral Investig. 2022 Jan;26(1):83-94. doi: 10.1007/s00784-021-04213-y. Epub 2021 Oct 13.
PubMed 34647147
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Investigation of Tongue Movement During Mastication for Completely Edentulous Patients Rehabilitated by Mandibular Implant Retained Overdenture
- ClinicalTrials.gov ID
- NCT06705114
- Acronym / sponsor ID
- A01010023RP
- Conditions
- Prosthesis Durability
- Keywords
- Mastication, implant, mandibular, ultrasound, tongue movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 26 Nov 2024 (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 aimed to examine the impact of mandibular implant overdentures on tongue movement during mastication.
Detailed description
Each patient received a newly constructed conventional complete denture. To construct the radiographic stent, the mandibular denture was duplicated in clear acrylic resin and modified by placing multiple holes filled with radiopaque gutta-percha points. A stereolithographic surgical guide was then constructed using a dual scan technique with cone beam computerized tomography (CBCT, i-CAT Vision®, Imaging Sciences International, Hatfield, PA). Two dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol. Patients were instructed to rinse their mouth with Chlorohexidine mouthwash just before the implant surgery and continue for one week. A prophylactic antibiotic (Amoxicillin and Clavulanic acid 125 mg) was administered one hour before the surgery and continued for one week after surgery. To control pain, a nonsteroidal anti-inflammatory drug (Ibuprofen 600 mg) was prescribed. After surgery, patients were prohibited from using the complete denture and were advised to follow a soft diet.
After one week, the mandibular denture was relieved and relined with soft relining material (Softliner; PROMEDICA) and delivered to the patient. After 3-4 months, the dental implants were exposed and ball abutments were screwed into the implants (Fig.1A). The housing of the ball attachments were incorporated into the fitting surface of the mandibular denture using a direct pick-up technique (Fig. 1B). The mandibular overdenture was then inserted into the patient's mouth and occlusal adjustment was done using articulating paper to remove any occlusal interferences. Follow-up visits were scheduled.
Tongue movement measurement The evaluation of tongue movement was conducted using an ultrasound imaging system (Toshiba Medical Systems Corporation, Tokyo, Japan) with a 3.1-MHz convex probe. A layer of ultrasound jelly (Sono Jelly, Toshiba Medical Systems Corporation) was applied to the patient's skin under the probe. The patient was instructed to sit in upright position, and the probe was placed under the chin area to allow the beam to pass through the distal surfaces of the second premolars on both the right and left sides. The probe was secured in place using a microphone stand (Panasonic System Networks Co., Ltd., Tokyo, Japan) with adjustable height and angle. The position of the tongue was confirmed on the B-mode image of the sagittal plane, which provided a two-dimensional recording of the slice through the oral cavity. The recording rate was 0.0476 seconds (21 frames per second). Ultrasound images were taken while the patient chewed 1/4 of a cookie in a normal manner until it was swallowed.
The ultrasound images were taken at two different oral conditions: 3 months after complete denture insertion and 3 months after mandibular implant overdenture insertion. The ultrasound data were exported from the imaging system via a USB port and transferred to a personal computer. The Articulate Assistant Advanced (AAA) software program version 221.2.0 was used to analyze the data. The software program provides a measurement fan, which is used to automatically set control points at the intersection of the tongue-surface spline and each radial axis. This is done using the AAA edge-detection algorithm, which detects dark-bright discontinuities in the image. (28) The spline was then fitted to the visible surface of the tongue in each relevant video frame (Fig. 2). From the start time (the beginning of mastication) to the end time (when the tongue moved up towards the palate at the start of swallowing), the tongue surface was traced in AAA.
The following items were measured:
1 -Duration of Chewing: From time of food ingestion to the time of beginning of first swallowing.
2- Cumulative displacement of the tongue during Chewing: The distance (in mm) from the tongue surface spline to the anchor point (A) was measured along the radial fan lines at three different points: 30 degrees posterior (B), the center (C), and 30 degrees anterior (D) (Fig. 3). This measurement process was repeated for consecutive video frames. The sum of absolute change between consecutive frames for all measurement points was detected.
3- Tongue surface shape during chewing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I: complete dentures | Active comparator | Procedure: complete dentureEach patient received a newly constructed conventional complete denture. |
| group II: mandibular implant overdenture | Active comparator | Procedure: implant overdentureTwo dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients were completely edentulous for at least one year, had a normal maxillo-mandibular relationship, and had available inter-arch space. They were nonsmokers and free from any systemic diseases that could affect implant osseointegration
Key exclusion criteria (1 listed)
- Patients with head and neck surgery, skeletal deformity, and temporomandibular joint disorder were excluded from the study.
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 dentureEach patient received a newly constructed conventional complete denture with optimal denture extension and lingualized balanced occlusal concept | Procedure or surgery | group I: complete dentures |
| implant overdentureTwo dental implants were inserted in the patient's mandibular arch at the canine region using guided surgery and a delayed loading protocol.After 3-4 months, the dental implants were exposed and ball abutments were screwed into the implants. The housing of the ball attachments were incorporated into the fitting surface of the mandibular denture using a direct pick-up technique (Fig. 1B). The mandibular overdenture was then inserted into the patient's mouth and occlusal adjustment was done using articulating paper to remove any occlusal interferences. Follow-up visits were scheduled. | Procedure or surgery | group II: mandibular implant overdenture |
Primary outcome
ultrasound investigation of tongue movement
Time frame: after 3 months of denture and overdenture insertion
The evaluation of tongue movement was conducted using an ultrasound imaging system (Toshiba Medical Systems Corporation, Tokyo, Japan) with a 3.1-MHz convex probe. A layer of ultrasound jelly (Sono Jelly, Toshiba Medical Systems Corporation) was applied to the patient's skin under the probe. The patient was instructed to sit in upright position, and the probe was placed under the chin area to allow the beam to pass through the distal surfaces of the second premolars on both the right and left sides. The probe was secured in place using a microphone stand (Panasonic System Networks Co., Ltd., Tokyo, Japan) with adjustable height and angle. The position of the tongue was confirmed on the B-mode image of the sagittal plane, which provided a two-dimensional recording of the slice through the oral cavity. The recording rate was 0.0476 seconds (21 frames per second). Ultrasound images were taken while the patient chewed 1/4 of a cookie in a normal manner until it was swallowed.
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 26 Nov 2024.
- Results publication: PubMed 34647147Goncalves GSY, de Magalhaes KMF, Rocha EP, Dos Santos PH, Assuncao WG. Oral health-related quality of life and satisfaction in edentulous patients rehabilitated with implant-supported full dentures all-on-four concept: a systematic review. Clin Oral Investig. 2022 Jan;26(1):83-94. doi: 10.1007/s00784-021-04213-y. Epub 2021 Oct 13.
- 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 complete denture and implant overdenture in people with Prosthesis Durability, 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 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 26 Nov 2024. 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?
ultrasound investigation of tongue movement (time frame: after 3 months of denture and overdenture insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705114, which also lists 1 linked publication.
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 26 Nov 2024.