Clinical trial · Interventional
Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Efficacy of Implant-Supported Maxillofacial Prostheses
NCT00006341CI-TRIAL-00020747completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implant | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Implant
- description
- A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses.
- interventionNames
- Other: Implant
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of early oral cancer lesions requiring one of the following: * Partial or total unilateral maxillectomy OR * Partial lateral mandibulectomy with or without partial glossectomy * Edentulous or edentulous in the maxillary arch prior to or after ablative surgery (maxillectomy group) * Partial mandibulectomy leaving the condyles intact bilaterally (mandibulectomy group) * Must have sufficient bone in the selected implant sites to accommodate 2-4 implants of at least 10 mm in length * No temporomandibular dysfunction and/or functionally restrictive opening * No requirement for total glossectomy, reconstructive maxillary surgery, or maxillary sinus lift * No requirement for radiotherapy after mandibular reconstructive surgery PATIENT CHARACTERISTICS: Age: * 35 to 80 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No oral discomfort that would preclude study * No complications after ablative or reconstructive surgery that would preclude dental rehabilitation with implants PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior or concurrent radiotherapy of greater than 5,500 cGY to potential implant site Surgery: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.