Evaluation of Locator Versus TITACH Attachment for Mandibular Overdentures.

NCT06228859 | Unknown DMC

• 1 other identifier: M10071020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Prosthesis Durability

Outcome Measures

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

  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.

  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.

  six months and one year after insertion.

Study Arms (2)

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

EXPERIMENTAL

locater groups or overdenture attachment

Procedure: overdentures with different attachments

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

EXPERIMENTAL

TITACH groups for overdenture attachment

Procedure: overdentures with different attachments

Interventions

overdentures with different attachments PROCEDURE

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

Also known as: prosthodontics

Group I (LOA): Patients were given overdentures with locator attachments.; Group II (TIA): Patients were given overdentures with TITACH attachment.

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Heba Wageh Abozaed

Al Mansurah, Dakahleia, 88001, Egypt

RECRUITING

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Denture, Overlay; Prosthodontics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Dentistry; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Heba W Abozaed, PhD

CONTACT

01091762662; heba_zeid@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 29, 2024
• Study Start: March 10, 2023
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

EG (1)