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Clinical Trials in India / NCT05332977
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Clinical Study Investigating the Efficiency and Complications Related to Two Different Procedures Used for the Preparation of Dentures Applied in Patients With Edentulous

NCT05332977 · tracked via the Priya Life Science India tracker
Sponsor
University of Zurich
Phase
Not applicable
Started
2022-05
Last updated
2022-04-18

Condition(s) studied

Edentulous Maxilla

Investigational drug(s) / intervention(s)

CAD-CAM fabricated provisional prosthesisDC (denture conversion) provisional prosthesis

CAD-CAM fabricated provisional prosthesis: Insertion of CAD-CAM fabricated provisional prosthesis (CAD-CAM) on axially placed or titled implants for rehabilitation of atrophic maxilla

DC (denture conversion) provisional prosthesis: Insertion of denture conversion (DC) provisional prosthesis on axially placed or titled implants for rehabilitation of atrophic maxilla

Study summary

The principal aim of the study is to evaluate the prosthetic complications with CAD-CAM fabricated provisional prostheses and denture conversion prostheses after 3 months of function. Supported restorations are now a predictable treatment modality for the rehabilitation of complete and partially edentulous jaws.Immediate loading of the placed implants is performed for the rehabilitation of the edentulous arch to improve patients' function. This can be usually done by converting the existing denture base of the patient or by making a CAD- CAM milled provisional prosthesis integrating digital workflow. A laboratory fabricated denture base can be converted into a screw-retained provisional prosthesis post implant placement. This is known as conversion prosthesis. However, drawbacks of these prostheses include increased chairside time for the clinician leading to inconvenience for the patient and a potential for an error in prosthesis fabrication. With the introduction of CAD-CAM technology, it is now possible to fabricate a provisional restoration using digital workflows. This workflow would help the clinicians save a considerable amount of chairside time and obtain potentially stronger restorations better polished and without contamination of surgical field. Studies assessing the soft tissue response and patient-reported outcome measures between denture conversion and CAD- CAM fabricated provisionals are currently lacking in the literature.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
Inclusion Criteria: Patients should be of minimum 18 years to be included in the study. * Patient with edentulous maxilla * Presence of natural teeth or dentures in the mandibular arch * Presence of adequate primary stability during implant placement. * Adequate bone volume to place at least 4 implants with regular platform of at least 6 mm in length * Presence of at least 6mm (height) of bone in the distal most prosthetic position (in the region of 2nd premolar or 1st molar) * Presence of at least 8 mm (height) and 6 mm (width) of bone in the anterior region (canine or lateral incisor) to place an implant of a regular diameter and a minimum length of 8 mm. * Presence of healed maxillary edentulous ridge (at least 3 months post extraction) * Written informed consent Exclusion Criteria: * Self reported history of bruxism * Uncontrolled diabetes (HbA1c\>7.5 mg/dl) * History of irradiation in the head and neck region * Inability to comply with annual implant maintenance follow up * Ridge profile not allowing the placement of a fixed prostheses. * Presence of any uncontrolled systemic disease that contraindicates implant placement. * Pregnant or lactating women

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
M.A. Rangoonwala College of Dental Sciences and Research Center, Department of Prosthodontics Pune India

More University of Zurich trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05332977 on ClinicalTrials.gov ↗ ← All trials in India