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RecruitingNCT06228859Updated Jan 29, 2024

Evaluation of Locator Versus TITACH Attachment for Mandibular Overdentures.

An interventional study of overdentures with different attachments in Prosthesis Durability, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 55 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled Mar 2023, registered Dec 2023).
  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
55 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Prosthesis Durability

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03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 36 is close to the median of 36 across 69 interventional studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    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.

Exclusion criteria

Exclusion Criteria:

    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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Group I (LOA): Patients were given overdentures with locator attachments.

    locater groups or overdenture attachment

    Procedure: overdentures with different attachments

  • Experimental
    Group II (TIA): Patients were given overdentures with TITACH attachment.

    TITACH groups for overdenture attachment

    Procedure: overdentures with different attachments

Interventions

  • Procedureoverdentures with different attachments

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

    Also known as: prosthodontics

06

What researchers measure

Primary outcomes

  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

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

Secondary outcomes

  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.

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

Other outcomes

  1. evaluate the marginal bone loss of the dental implant for each patient.

    a long cone paralleling radiographs captured by a digital device

    Time frame: six months and one year after insertion.

07

Study locations

1 of 1 sites recruiting
  • Heba Wageh Abozaed
    Mansoura, Dakahleia 88001, Egypt
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Dec 2024, 21 months after the start.

Of 48 non-industry interventional studies with no phase under Prosthesis Failure, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 21 months is above that.

Counting every sponsor, half of 50 studies reached it within 18 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2023
First posted
Jan 29, 2024
StartActual
Mar 10, 2023
Primary completionEst.
Dec 2024
CompletionEst.
Sep 2025
Last update
Jan 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06228859
Responsible party
Heba Wageh Abozaed Elsaed Mansour (Associate professor, Mansoura University) — Principal investigator
First posted
Jan 29, 2024
Start date
Mar 10, 2023
Primary completion
Dec 2024 (estimated)
Completion
Sep 2025 (estimated)
Last update
Jan 29, 2024

Study contacts

Heba W Abozaed, PhD
Contact
heba_zeid@mans.edu.eg
01091762662

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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