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Prosthesis DurabilityNCT06228859

Evaluation of Locator Versus TITACH Attachment for Mandibular Overdentures.

A study testing overdentures with different attachments in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this randomized controlled clinical study was to evaluate the locator and TITACH attachments used for retaining mandibular 2-implant overdentures regarding retention , bite force and implant marginal bone loss after overdenture insertion Read more about this study

Who is it for?
Ages 55 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Prosthesis Durability
What is being tested?
overdentures with different attachments
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteEgypt
Study dates
10 Mar 2023to Sep 2025
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 55 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1) Complete edentulism with adequate residual alveolar bone quantity (height and width) and quality (density) at the area between the mental foramina (confirmed by cone beam CT, I -CAT, Pennsylvania, USA), 2) All patients had Angle's class I maxilla-mandibular relation with suitable inter-arch space (verified by a tentative jaw relation), and 3) All patients complained of inadequate retention and stability of their conventional mandibular dentures.

Who cannot join

  • 1) systemic conditions that impede Osseo-integration, such as uncontrolled diabetes, osteoporosis, and head and neck radiation, 2) hazardous behaviors such as smoking, bruxism, and drunkenness, 3) individuals with a history of persistent TMJ disorders or reduced neuromuscular control.

Trial locations and contacts

1 site in 1 country.

Heba W Abozaed, PhD contact

01091762662

heba_zeid@mans.edu.eg

Egypt1 site, 1 recruiting
  • Heba Wageh Abozaed

    Al Mansurah, Dakahleia, 88001

    Heba W Abozaed, heba_zeid@mans.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Evaluation of Locator Versus TITACH Attachment for Mandibular 2-Implant Overdentures. One-year Randomized Controlled Clinical Trial.

The purpose of this randomized controlled clinical study was to evaluate the locator and TITACH attachments used for retaining mandibular 2-implant overdentures regarding retention , bite force and implant marginal bone loss after overdenture insertion

Read the detailed description

Locator (resilient stud) attachments have grown in favor in recent decades because they are self-aligned, give dual retention, and need less inter-arch space. The attachment's low profile may be beneficial in individuals with limited restorative space for reducing denture breakage . Furthermore, the interchangeable color-coded nylon inserts come in a variety of retention levels. Furthermore, the attachments allow for limited hinge movement and may adjust implant inclination of up to 40 degrees. However, nylon inserts exhibit significant wear and distortion and need intensive care. Elsyad et al, discovered that Locator attachments had the greatest incidence of prosthetic problems (particularly wear/distortion and replacement of retentive components) in a recent 5-year randomized controlled experiment .

A current study (TITACH) attachment (Implanova Dental Implants, Dental Evolutions Inc., USA) was designed to alleviate the issues associated with Locator attachments. Unlike the Locator system's nylon attachments, this connection enables metal-to-metal contact between the abutment and its cap. TITACH abutment, TITACH metal cap, and a silicone sleeve are the three components. When the metal cap engages the abutment, vertical holes allow it to open. The silicone sleeve functions as a block-out during cap pick-up. This type of connection may accommodate up to 33o divergence for a single implant or 66o divergence for contralateral implants. A vertical clearance of 4.5 mm and a diameter of 6 mm are required to fit the cap. It enables up to 0.2 mm of vertical cushioning, allowing for mucosal compression during function and progressive prosthesis seating. Furthermore, each attachment can withstand 7-10 lbs. of force.

Retention is the power of a dental prosthesis to withstand pressures of dislodgment along the line of installation. Prosthesis retention has been established as one of the most essential aspects in achieving successful implant overdenture therapy and increased patient satisfaction.In a previous in-vitro study, TITACH attachments were related to better retentive force results than Locator attachments, according to the authors. Although in-vitro retention testing provides for the standardization of testing conditions, Oral conditions such as mucosa, saliva, temperature, and masticatory stress may affect retention values24. Because intraoral parameters such as the presence of saliva and the structure of the residual ridge have been taken to be considered, objective assessment of clinical retention forces is preferable to subjective evaluation. Maximum biting force is determined by the activity of the jaw's elevator muscles, which is regulated by Cranio-mandibular biomechanics. In individuals with ridge resorption, dental implants will enhance biting force as part of masticatory efficiency. Mandibular implant-supported overdentures have at least double the masticatory biting force of conventional dentures.

Marginal bone loss (MBL) is a multifactorial occurrence that occurs around the cervical region of dental implants. Monitoring MBL surrounding implants is critical for determining dental implant success because it is thought to be a reliable predictor of bone response to surgery and occlusal loading. Whatever causes it, marginal bone loss is a major contributor to the development of peri-implantitis.

Being tested
overdentures with different attachments
Medical subject headings
Prosthesis Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • overdentures with different attachmentsProcedure or surgery

    Also called prosthodontics

    different types of overdenture attachments in relation to retention, bite force, and periimplant tissue health.

Study groups in NCT06228859
Study groupRoleWhat they receive
Group I (LOA): Patients were given overdentures with locator attachments.Experimentallocater groups or overdenture attachment
Receives: Procedure: overdentures with different attachments
Group II (TIA): Patients were given overdentures with TITACH attachment.ExperimentalTITACH groups for overdenture attachment
Receives: Procedure: overdentures with different attachments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention forces were measured using a digital force-meter.

    Wearing mandibular dentures and resting his chin on the apparatus chin rest, each patient was instructed to move his head until the L-shaped hooks touched the U-shaped fork at the same time. The force-meter was then moved vertically until the overdenture was removed from its position , at which point the force-meter reading in (N) was recorded. The measurements were completed three times, and the mean was calculated

    Measured: Baseline (at time of insertion), six months, one year after insertion

Secondary outcomes (1)
  1. Maximum bite forces were measured bilaterally using a bite force transducer.

    The device consists of a bite fork equipped with strain gauges, which were placed between the occlusal surfaces of the denture teeth in the first molar region. Patients were instructed to bite as hard as possible on the apparatus fork for a few seconds, and measurements were taken three times for each side. Left and right force measurements were added, and the mean was statistically analyzed.

    Measured: Baseline (at time of insertion), six months, one year after insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start10 Mar 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionSep 2025 (estimated)

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228859
Sponsor's protocol ID
M10071020
Status last verified
Jan 2024
First submitted
16 Dec 2023
Last updated
29 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing overdentures with different attachments 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: status not confirmed, as of the sponsor's last update on 29 Jan 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Heba W Abozaed, PhD (01091762662, heba_zeid@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention forces were measured using a digital force-meter. (time frame: Baseline (at time of insertion), six months, one year after insertion). 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 29 Jan 2024.

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