Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572891
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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 patients 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
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 eg 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None