NCT06572891

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

Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients with Compromised Ridge: a Study of Patient Satisfaction and Oral Health Related Quality of Life

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Inclusion criteria: * 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 as verified by cone beam computed tomography (CBCT), especially in the proposed implant sites. * Exclusion Criteria: * 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. All patients were informed about the detailed treatment plan and received a written informed consent to be signed. II) Preparation of the patient for implant placement: * Fabrication of maxillary obturator. * Cone beam computed tomography (CBCT) was performed for all patients to accurately plan implant location, diameter, and angulation. III) Surgical phase: * Surgery was performed under local anaesthesia. * All patients received single-piece compressive implants in the proper positions according to the case demands. * The patients were prescribed systemic antibiotics for one week, anti-inflammatory, analgesic, and mouthwash. IV) Prosthetic phase: * Necks of placed implants bent up to 15 degrees to be parallel placed. * The maxillary obturator was adjusted on the poured mode, and modified and access holes made above the abutment were finally relined in the patient's mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol. IV) Evaluation: * Patient Satisfaction Based on Visual Analog Scale (VAS) * Oral health impact profile for edentulous patient (OHIP-EDENT) * Obturator Functioning Scale

Conditions

• Patient Satisfaction

Interventions

Type	Name	Description
OTHER	Maxillary obturator	conventional acrylic obturator
OTHER	Implant supported obturator	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

Timeline

• Start date: 2023-05-07
• Primary completion: 2024-06-20
• Completion: 2024-07-20
• First posted: 2024-08-27
• Last updated: 2024-09-23

Locations

1 site across 1 country: Egypt