Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006341
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2000-10-04
Brief Title:
Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Efficacy of Implant-Supported Maxillofacial Prostheses
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE The use of dentures and dental implants may help maintain chewing and speaking ability following surgery to remove tumors in the mouth
PURPOSE Phase II trial to study the effectiveness of dentures and dental implants in maintaining the ability to chew and speak in patients undergoing surgery for mouth cancer
PURPOSE Phase II trial to study the effectiveness of dentures and dental implants in maintaining the ability to chew and speak in patients undergoing surgery for mouth cancer
Detailed Description:
OBJECTIVES
Determine whether conventional or implant supported dental prostheses and current surgical reconstructive procedures restore oral function and quality of life to pre-cancer surgery levels in patients with early oral cancer
OUTLINE Patients complete a series of objective and subjective functional tests questionnaires and baseline examinations Within 1-5 days patients undergo the composite resection including reconstructive surgery for the mandibulectomy group Patients in the maxillectomy group receive an immediate maxillary surgical obturator Approximately 6 weeks after ablative surgery some patients receive radiotherapy for 5-7 weeks
Patients receive 2-4 implants at 12-16 weeks after completion of radiotherapy or 8-16 weeks after ablative surgery Patients then receive conventional dentures at 4-22 weeks after implant surgery Implants are exposed during 27-48 weeks after placement and abutments connected for fabricating dental prostheses Approximately 8 weeks are needed to fabricate the implant supported prosthesis
Patients complete quality of life and other questionnaires prior to and at 8-21 weeks after surgery 16 weeks after conventional denture insertion and then 16 weeks after implant supported prosthesis insertion
Patients are followed every 6 months for at least 3 years
PROJECTED ACCRUAL A total of 62 patients 22 requiring maxillectomy and 40 requiring mandibulectomy will be accrued for this study within 42 months
Determine whether conventional or implant supported dental prostheses and current surgical reconstructive procedures restore oral function and quality of life to pre-cancer surgery levels in patients with early oral cancer
OUTLINE Patients complete a series of objective and subjective functional tests questionnaires and baseline examinations Within 1-5 days patients undergo the composite resection including reconstructive surgery for the mandibulectomy group Patients in the maxillectomy group receive an immediate maxillary surgical obturator Approximately 6 weeks after ablative surgery some patients receive radiotherapy for 5-7 weeks
Patients receive 2-4 implants at 12-16 weeks after completion of radiotherapy or 8-16 weeks after ablative surgery Patients then receive conventional dentures at 4-22 weeks after implant surgery Implants are exposed during 27-48 weeks after placement and abutments connected for fabricating dental prostheses Approximately 8 weeks are needed to fabricate the implant supported prosthesis
Patients complete quality of life and other questionnaires prior to and at 8-21 weeks after surgery 16 weeks after conventional denture insertion and then 16 weeks after implant supported prosthesis insertion
Patients are followed every 6 months for at least 3 years
PROJECTED ACCRUAL A total of 62 patients 22 requiring maxillectomy and 40 requiring mandibulectomy will be accrued for this study within 42 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1606 | None | None | None |
| UCLA-HSPC-940205413 | None | None | None |
| UCLA-DEN-1R01DE11255 | None | None | None |
| UCLA-HSPC-940205411 | None | None | None |