Prosthesis DurabilityNCT06622837
Swallowing Threshold and Efficiency for Maxillary Implant Assisted Overdenture
A study testing implant overdenture in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to compare the swallowing threshold and efficiency of conventional maxillary implant overdenture and palatless designs. 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?
- implant overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 Aug 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
- patient had sufficient bone quantity in the area between the mental foramina, sufficient inter-arch space, normal maxilla-mandibular relation, and have been edentulous for at least one year
Who cannot join
- Patients with uncontrolled systemic diseases, parafunctional habits, temporomandibular joint disorders, and a history of head/neck surgery were excluded, as were smoking and those who undergo radiation therapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, mansoura university Mansoura, Egypt,
Al Mansurah, 3551
About this study
Official title: Within-subject Evaluation of Swallowing Threshold and Efficiency for Maxillary Implant Assisted Overdenture with and Without Palatal Coverage.
This study aimed to compare the swallowing threshold and efficiency of conventional maxillary implant overdenture and palatless designs.
Read the detailed description
New complete dentures were constructed for each participants using the conventional technique. The dentures were then inserted and adjusted according to a lingualized balanced occlusal scheme. The dentures were duplicated using clear acrylic resin material. Radiopaque gutta percha markers were placed on the labial, buccal, and lingual flanges of the clear resin duplicate at different axial planes to create a radiographic stent.
For each participant, dual scan was performed using cone beam computerized tomography ( i-CAT, Pennsylvania, USA). One scan was taken while the patient wore the radiographic stent, and the other scan was taken for the stent extra orally. These two scans were then superimposed to create an implant plan and construct stereolithographic surgical guides. With the assistance of these stereolithographic surgical guides and submerged surgical technique, 4 dental implants (IS III Active Implant, Neo BioTech) were placed in the canines and premolars regions of the maxillary arch, and 2 dental implants were placed in the canines region of the mandibular arch.
Each participants instructed to take Prophylactic broad spectrum antibiotic (875mg Amoxicillin and Clavulanic acid 125 mg) one hour before the surgery and for 7 days and rinsed their mouth with an antiseptic mouthwash (2% chlorohexidine) for 2 weeks after surgery. Additionally, non-steroidal anti-inflammatory drug (Diclofenac tablet 50 mg) was prescribed to control postoperative pain. One week after the surgery, the dentures were relived and relined with soft liner material (Mucosoft, Parkell, Edgewood. USA) and delivered to the participants. Follow-up visits were scheduled.
After the osseointegration period (3 months for the mandibular arch and 6 months for the maxillary arch), locator attachments (Neo Bio Tech) were screwed to the implants. Each patient received the following types of overdentures:
- One mandibular implant-retained overdenture: After reliving the mandibular denture, direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the mandibular denture.
- Two designs of MaxIODs:
- Conventional MaxIOD: After relieving the conventional maxillary denture, direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the conventional maxillary denture.
- Palateless MaxIOD: The conventional maxillary denture was duplicated and the palatal part was cut out, finished, and polished. The fitting surface was relived and direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the palateless maxillary denture.
The participants were randomly allocated into two equal groups (7 per group). Randomization process was carried out by an independent examiner using a computer program, specifically Microsoft Excel. The first group of 7 participants received conventional MaxIODs. After a period of three months, the TOMASS test was done. Following this, they wore a palatless MaxIODs for an additional 3 months, after which the test was repeated. The second group of 7 patients initially received palatless MaxIODs. After three months of use, the TOMASS test was done. They then received conventional MaxIODs and the test was repeated after an additional three months. This randomization process was implemented in order to minimize the effect of the order of restoration on the measurements of swallowing threshold and efficiency.
Swallowing assessment:
TOMASS test was utilized to assess participants\' swallowing abilities. (30) For this study, a commercially available cracker biscuit was used. Participants were instructed to sit on a chair in upright position and to eat the biscuit comfortably and as quickly as possible. They were also asked to say their name out loud as it indicate that they had finished the test. Using a video recorder the procedure was recorded for further analysis.
The recorded videos were then analyzed using the Avidemux 2.6 program to measure the following:
- Swallowing threshold, which is the duration of chewing until the first swallow (determined by the moment of laryngeal elevation)
- The TOMASS test parameters:
- Number of bites: The number of discrete bites taken to finish the cracker
- Number of masticatory cycles: As each cyclical mandibular movement up-down
- Number of swallows: As each vertical movement of the thyroid cartilage
- Total ingestion time: The time taken to complete the ingestion of the cracker from the first bite to the last.
- Conditions
- Prosthesis Durability
- Being tested
- implant overdenture
- Keywords
- Palatless,, Maxillary, Implant, Overdenture, swallowing
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant overdentureProcedure or surgery
With the assistance of these stereolithographic surgical guides and submerged surgical technique, 4 dental implants (IS III Active Implant, Neo BioTech) were placed in the canines and premolars regions of the maxillary arch, and 2 dental implants were placed in the canines region of the mandibular arch.
| Study group | Role | What they receive |
|---|---|---|
| group I conventional maxillary implant overdenture | Active comparator | Conventional MaxIOD: After relieving the conventional maxillary denture, direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the conventional maxillary denture. Receives: Procedure: implant overdenture |
| group II palatless maxillary implant overdenture | Active comparator | Palateless MaxIOD: The conventional maxillary denture was duplicated and the palatal part was cut out, finished, and polished. The fitting surface was relived and direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the palateless maxillary denture. Receives: Procedure: implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
swallowing evaluation
TOMASS test was utilized to assess participants\' swallowing abilities
Measured: after 3 months of overdenture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jul 2023
- Primary completion30 Jul 2024
- Study completion30 Aug 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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdallah Mohammed Ibrahim, PhD, Principal investigator, Mansoura university, Faculty of dentistry, prosthodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622837
- Sponsor's protocol ID
- A0408024RP
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karlsson F, Lovric L, Matthelie J, Brage L, Hagglund P. A Within-Subject Comparison of Face-to-Face and Telemedicine Screening Using the Timed Water Swallow Test (TWST) and the Test of Mastication and Swallowing of Solids (TOMASS). Dysphagia. 2023 Feb;38(1):483-490. doi: 10.1007/s00455-022-10490-w. Epub 2022 Jul 9.
PubMed 35809097
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Within-subject Evaluation of Swallowing Threshold and Efficiency for Maxillary Implant Assisted Overdenture with and Without Palatal Coverage.
- ClinicalTrials.gov ID
- NCT06622837
- Acronym / sponsor ID
- A0408024RP
- Conditions
- Prosthesis Durability
- Keywords
- Palatless,, Maxillary, Implant, Overdenture, swallowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 2 Oct 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 compare the swallowing threshold and efficiency of conventional maxillary implant overdenture and palatless designs.
Detailed description
New complete dentures were constructed for each participants using the conventional technique. The dentures were then inserted and adjusted according to a lingualized balanced occlusal scheme. The dentures were duplicated using clear acrylic resin material. Radiopaque gutta percha markers were placed on the labial, buccal, and lingual flanges of the clear resin duplicate at different axial planes to create a radiographic stent.
For each participant, dual scan was performed using cone beam computerized tomography ( i-CAT, Pennsylvania, USA). One scan was taken while the patient wore the radiographic stent, and the other scan was taken for the stent extra orally. These two scans were then superimposed to create an implant plan and construct stereolithographic surgical guides. With the assistance of these stereolithographic surgical guides and submerged surgical technique, 4 dental implants (IS III Active Implant, Neo BioTech) were placed in the canines and premolars regions of the maxillary arch, and 2 dental implants were placed in the canines region of the mandibular arch.
Each participants instructed to take Prophylactic broad spectrum antibiotic (875mg Amoxicillin and Clavulanic acid 125 mg) one hour before the surgery and for 7 days and rinsed their mouth with an antiseptic mouthwash (2% chlorohexidine) for 2 weeks after surgery. Additionally, non-steroidal anti-inflammatory drug (Diclofenac tablet 50 mg) was prescribed to control postoperative pain. One week after the surgery, the dentures were relived and relined with soft liner material (Mucosoft, Parkell, Edgewood. USA) and delivered to the participants. Follow-up visits were scheduled.
After the osseointegration period (3 months for the mandibular arch and 6 months for the maxillary arch), locator attachments (Neo Bio Tech) were screwed to the implants. Each patient received the following types of overdentures:
- One mandibular implant-retained overdenture: After reliving the mandibular denture, direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the mandibular denture.
- Two designs of MaxIODs:
- Conventional MaxIOD: After relieving the conventional maxillary denture, direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the conventional maxillary denture.
- Palateless MaxIOD: The conventional maxillary denture was duplicated and the palatal part was cut out, finished, and polished. The fitting surface was relived and direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the palateless maxillary denture.
The participants were randomly allocated into two equal groups (7 per group). Randomization process was carried out by an independent examiner using a computer program, specifically Microsoft Excel. The first group of 7 participants received conventional MaxIODs. After a period of three months, the TOMASS test was done. Following this, they wore a palatless MaxIODs for an additional 3 months, after which the test was repeated. The second group of 7 patients initially received palatless MaxIODs. After three months of use, the TOMASS test was done. They then received conventional MaxIODs and the test was repeated after an additional three months. This randomization process was implemented in order to minimize the effect of the order of restoration on the measurements of swallowing threshold and efficiency.
Swallowing assessment:
TOMASS test was utilized to assess participants\' swallowing abilities. (30) For this study, a commercially available cracker biscuit was used. Participants were instructed to sit on a chair in upright position and to eat the biscuit comfortably and as quickly as possible. They were also asked to say their name out loud as it indicate that they had finished the test. Using a video recorder the procedure was recorded for further analysis.
The recorded videos were then analyzed using the Avidemux 2.6 program to measure the following:
- Swallowing threshold, which is the duration of chewing until the first swallow (determined by the moment of laryngeal elevation)
- The TOMASS test parameters:
- Number of bites: The number of discrete bites taken to finish the cracker
- Number of masticatory cycles: As each cyclical mandibular movement up-down
- Number of swallows: As each vertical movement of the thyroid cartilage
- Total ingestion time: The time taken to complete the ingestion of the cracker from the first bite to the last.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I conventional maxillary implant overdenture | Active comparator | Procedure: implant overdentureConventional MaxIOD: After relieving the conventional maxillary denture, direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the conventional maxillary denture. |
| group II palatless maxillary implant overdenture | Active comparator | Procedure: implant overdenturePalateless MaxIOD: The conventional maxillary denture was duplicated and the palatal part was cut out, finished, and polished. The fitting surface was relived and direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the palateless maxillary denture. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient had sufficient bone quantity in the area between the mental foramina, sufficient inter-arch space, normal maxilla-mandibular relation, and have been edentulous for at least one year
Key exclusion criteria (1 listed)
- Patients with uncontrolled systemic diseases, parafunctional habits, temporomandibular joint disorders, and a history of head/neck surgery were excluded, as were smoking and those who undergo radiation 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 |
|---|---|---|
| implant overdentureWith the assistance of these stereolithographic surgical guides and submerged surgical technique, 4 dental implants (IS III Active Implant, Neo BioTech) were placed in the canines and premolars regions of the maxillary arch, and 2 dental implants were placed in the canines region of the mandibular arch. | Procedure or surgery | group I conventional maxillary implant overdenture, group II palatless maxillary implant overdenture |
Primary outcome
swallowing evaluation
Time frame: after 3 months of overdenture insertion
TOMASS test was utilized to assess participants\' swallowing abilities
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 2 Oct 2024.
- Background: PubMed 35809097Karlsson F, Lovric L, Matthelie J, Brage L, Hagglund P. A Within-Subject Comparison of Face-to-Face and Telemedicine Screening Using the Timed Water Swallow Test (TWST) and the Test of Mastication and Swallowing of Solids (TOMASS). Dysphagia. 2023 Feb;38(1):483-490. doi: 10.1007/s00455-022-10490-w. Epub 2022 Jul 9.
- 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.
Abdallah Mohammed Ibrahim, PhD principal investigator
Mansoura university, Faculty of dentistry, prosthodontics department
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 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 2 Oct 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?
swallowing evaluation (time frame: after 3 months of 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 NCT06622837, 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 2 Oct 2024.