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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
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.
* 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
Age
45 - 65 years
Sex
ALL
Healthy Volunteers
No
Faculty of dentistry, mansoura university
Al Mansurah, Dakahlia Governorate, Egypt
Start Date
May 7, 2023
Primary Completion Date
June 20, 2024
Completion Date
July 20, 2024
Last Updated
September 23, 2024
20
ACTUAL participants
Maxillary obturator
OTHER
Implant supported obturator
OTHER
Lead Sponsor
Mansoura University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05583006