Health Condition 1: K06- Other disorders of gingiva and edentulous alveolar ridge
Conditions
Interventions
Intervention1: implant placement in radiated patients: Patients who underwent radiation therapy to the head and neck region would receive implants. This would be followed by prosthetic rehabilitation.
Sponsors
Investigator Initiated Study sponsored by Oral Reconstruction Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Study design: Prospective parallel arm cohort study Inclusion criteria: Patients with hopeless prognosis teeth that require replacement. Patients with expected extended edentulous spaces during or after ablative oral cancer surgery. Can be either in upper or lower jaw. Implants to be placed in either native bone or reconstructed bone.
Exclusion criteria
Exclusion criteria: Patients with single tooth replacements or short edentulous spans of 2 teeth. Patients who have an adequately remaining functional dentition (including shortened dental arch). Patients with additional comorbidities like uncontrolled diabetes mellitus, immunotherapy, concomitant/ adjuvant/ chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline measurements at time of implant placement: Implant stability measurements, Initial depth of implant placement (IDIP), Oral health related QoL questionnaires: OHIP, EORTC QoL, EORTC H&N. Follow up time periods: Follow up periods: 6 months and 12 months following prosthesis delivery. During each of these time periods, the following measurements will be made: 1. Clinical evaluation of peri-implant soft tissues: Plaque index (Mombelli et al, 1987); Bleeding index (Mombelli et al, 1987); Gingival index (LÃ?¶e & Sillnes, 1963) and Probing depth. 2. Implant stability measurements by RFA 3. Radiographic evaluation of marginal bone remodellingTimepoint: Baseline measurements at time of implant placement: Implant stability measurements, Initial depth of implant placement (IDIP), Oral health related QoL questionnaires: OHIP, EORTC QoL, EORTC H&N. Follow up time periods: Follow up periods: 6 months and 12 months following prosthesis delivery. During each of these time periods, the following measurements will be made: 1. Clinical evaluation of peri-implant soft tissues: Plaque index (Mombelli et al, 1987); Bleeding index (Mombelli et al, 1987); Gingival index (LÃ?¶e & Sillnes, 1963) and Probing depth. 2. Implant stability measurements by RFA 3. Radiographic evaluation of marginal bone remodelling | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral Health Impact ProfileTimepoint: baseline, 12 months post prosthesis, 3 years post prosthesis | — |
Countries
India
Contacts
Public ContactVinay V Kumar
Oral Rehabilitation Center
Outcome results
None listed