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EVALUATION OF DENTURE FUNCTION IN PATIENTS AFTER REMOVAL OF LOWER JAW AND RECONSTRUCTION (after tumor surgery)

A PROSPECTIVE RANDOMIZED CONTROLLED STUDY ON REHABILITATION OF RECONSTRUCTED MANDIBLE WITH 2 OR MORE THAN 4 IMPLANT SUPPORTED OVER DENTURE - RECON-IMPL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002764
Enrollment
50
Registered
2012-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K080- Exfoliation of teeth due to systemic causes Health Condition 2: null- Patients with mandibular defects post resection for benign or malignant lesions that have been reconstructed with free fibula vascularized flap for whom dental rehabilitation has to be carried out.

Interventions

Intervention1: removeable partial denture supported by 4 titanium dental implants: in this group, removeable partial denture would be provided after insertion of 4 dental implants. Four dental implant

Sponsors

Dr Vinay V Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Partly dentate patients who have undergone free fibula flap reconstuction of a resection defect of mandible by free fibula flap. Patients should have remaining natural dentition on the native mandible side so that implants are not to be inserted in the native mandible. No local and systemic contraindication for implantation. History of radiotherapy will not be considered as a contraindication for implantation. Favorable inter-ridge relation of the reconstructed hemi-mandible to allow adequate functional rehabilitation of implant supported prosthesis. Sufficient bone in the reconstructed mandible to place implants without augmentation procedures. To allow adaptation existing dentures have to be worn for at least for 3 months prior to recruitment to the study.

Exclusion criteria

Exclusion criteria: Patient not meeting the incusion criteria. • Patients with mandible defects not confirming to L defects or large soft tissue defects that involve the tongue and tonsils. • Completely edentulous patients

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to have longitudinal case controlled study data on the difference of quality of life measurements of these patients who at the baseline have non implant supported removable partial denture when compared to finalized treatment outcome with implant supported removable partial dentures.Timepoint: Baseline (at prosthesis insertion) 6 months following prosthesis insertion 12 months following prosthesis insertion

Secondary

MeasureTime frame
The secondary objective of this randomized clinical study is to evaluate the treatment outcome using two implants- or four implants- supported removable partial dentures in patients with reconstructed hemi mandible (with free fibula flap) post resectionTimepoint: Baseline (at prosthesis insertion) 6 months following prosthesis insertion 12 months following prosthesis insertion

Countries

India

Contacts

Public ContactDr Vinay V Kumar

M R Ambedkar Dental College and Hospital

veezo@rediffmail.com9739209043

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 10, 2026