Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients

NCT06572891 | Completed

• 1 other identifier: M0104023RP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This within-patient study aimed to compare the satisfaction and oral health-related quality of life (OHRQoL) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants.

Conditions

Patient Satisfaction

Keywords

VAS; OHIP-EDENT; Obturator Functioning Scale

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Patient Satisfaction Based on Visual Analog Scale The patients were asked to rate their overall satisfaction with the dentures on a 100-mm visual analogue scale (VAS) for each type of prosthesis. The anchor of the left end of the VAS was defined as 'completely dissatisfied' and that of the opposite side as 'completely satisfied'

  6 months

Secondary Outcomes (2)

• Oral health impact profile for edentulous patient (OHIP-EDENT)

  6 months

• - Obturator Functioning Scale

  6 months

Study Arms (2)

Conventional maxillary obturator

ACTIVE COMPARATOR

conventional acrylic obturator for each patient

Other: Maxillary obturator

Implant supported maxillary obturator

ACTIVE COMPARATOR

Implant-supported maxillary obturator (compressive implants)

Other: Implant supported obturator

Interventions

Maxillary obturator OTHER

conventional acrylic obturator

Conventional maxillary obturator

Implant supported obturator OTHER

Implants inserted as planned The necks of the implants were bent up to 15 degrees to be parallel. * The maxillary obturator was adjusted on the poured mode, modified and access holes will be made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol. * Impressions were made

Implant supported maxillary obturator

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
• Residual alveolar ridge quantity and quality will be verified by cone beam computed tomography (CBCT) especially in the proposed implant sites.

You may not qualify if:

• Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
• Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6-months)
• Patients with local inflammation that may cause interference with implant placement.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

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

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: May 7, 2023
• Primary Completion: June 20, 2024
• Study Completion: July 20, 2024
• Last Updated: September 23, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)