Swallowing Threshold and Efficiency for Maxillary Implant Assisted Overdenture

NCT06622837 | Completed

• 1 other identifier: A0408024RP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the swallowing threshold and efficiency of conventional maxillary implant overdenture and palatless designs.

Conditions

Prosthesis Durability

Keywords

Palatless,; Maxillary; Implant; Overdenture; swallowing

Outcome Measures

Primary Outcomes (1)

• swallowing evaluation

  TOMASS test was utilized to assess participants\' swallowing abilities

  after 3 months of overdenture insertion

Study Arms (2)

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.

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.

Procedure: implant overdenture

Interventions

implant overdenture PROCEDURE

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.

group I conventional maxillary implant overdenture; group II palatless maxillary implant overdenture

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

faculty of dentistry, mansoura university Mansoura, Egypt,

Al Mansurah, 3551, Egypt

Location

Related Publications (1)

• 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.

  PMID: 35809097 BACKGROUND

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdallah Mohammed Ibrahim, PhD

  Mansoura university, Faculty of dentistry, prosthodontics department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: July 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)