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Utilization of Guide Flange Prosthesis to prevent mandibular deviation in oral cancer patients who undergo segmental/hemi-mandibulectomy: A randomized controlled trial.

Impact of Guide Flange Prosthesis in ORal Cancer patients with Mandibulectomy defects on post operative functional outcomes: A randomized controlled trial. - P-ORCMan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077207
Enrollment
80
Registered
2024-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C031- Malignant neoplasm of lower gum

Interventions

Intervention1: Group-A (Guide flange prosthesis + Routine exercises): Patients in the intervention arm will be provided a guide flange prosthesis to apply in addition to routine exercises to prevent m

Sponsors

ATUL ANAND
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Treatment naive oral cavity cancer patients undergoing segmental or hemi-mandibulectomy as part of surgical resection with resultant mandibular deviation of more than 5mm, and/or complaining of malocclusion. Mandibular defect not crossing the midline and no skeletal reconstruction has been made for mandibular defect. Eastern Co-operative Oncology Group (ECOG) performance status 0-2

Exclusion criteria

Exclusion criteria: Patients with mouth opening less than 2 cm resulting in difficulty in obtaining the dental impression. Patients with recurrent oral cavity cancer having a history of surgery involving mandibular resection of any extent. Infected surgical wound or persistent oro-cutaneous fistula during implant measurement.

Design outcomes

Primary

MeasureTime frame
To compare the mandibular deviation from the midline in the two treatment arms at 3 and 6 months post-surgery.Timepoint: 3 and 6 months post surgery.

Secondary

MeasureTime frame
1. To compare the functional outcomes in the two treatment arms at 3 and 6 months post-surgery using- a. University of Washington (UoW) quality of life questionnaire for head and neck cancer patients. b. Overall quality of life using the Functional Assessment of Cancer Therapy- FACT-G and FACT-H&N questionnaires. 2. To compare the mean biting force in two treatment arms at 3 and 6 months post-surgery.Timepoint: 3 and 6 months post-surgery

Countries

India

Contacts

Public ContactDr Dharma Ram Poonia

All India Institute of Medical Sciences- Jodhpur

drdharmapoonia@gmail.com9958654196

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026