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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Egypt

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:

  1. 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.
  2. 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:

  1. Swallowing threshold, which is the duration of chewing until the first swallow (determined by the moment of laryngeal elevation)
  2. The TOMASS test parameters:
  3. Number of bites: The number of discrete bites taken to finish the cracker
  4. Number of masticatory cycles: As each cyclical mandibular movement up-down
  5. Number of swallows: As each vertical movement of the thyroid cartilage
  6. Total ingestion time: The time taken to complete the ingestion of the cracker from the first bite to the last.
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 groups in NCT06622837
Study groupRoleWhat they receive
group I conventional maxillary implant overdentureActive comparatorConventional 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 overdentureActive comparatorPalateless 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.

  1. 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.

  1. First posted2 Oct 2024
  2. Study start1 Jul 2023
  3. Primary completion30 Jul 2024
  4. Study completion30 Aug 2024

Resources

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)
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

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.

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