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

NCT05332977 | Not Yet Recruiting

• 1 other identifier: CAD-CAM vs DC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edentulous Maxilla

Keywords

CAD-CAM integrating digital workflow

Outcome Measures

Primary Outcomes (1)

• Complications of CAD-CAM prosthesis

  The primary outcome of the study is the evaluation of prosthetic complications of CAD-CAM fabricated and denture-conversion prosthesis using modified USPHS scores at 3 months of function. USPHS (United States Public Health Service) criteria A, B, C D are used where when rated A an excellent restoration is achieved and D is rated as failure.

  3 months of function

Secondary Outcomes (13)

• Survival rates

  1 year, 3 years and 5 years after insertion of final prosthesis

• Technical outcomes and complications: Prosthetic level

  4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis

• Technical outcomes and complications: Implant level

  4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis

• VAS provisional prosthesis

  4 weeks - after insertion of provisional prosthesis; 4 weeks, 1 year, 3 and 5 years after final prosthesis

• Evaluation about ease of surgery

  8 weeks after interim prosthesis insertion

Study Arms (2)

CAD-CAM fabricated provisional prothesis

EXPERIMENTAL

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

Device: CAD-CAM fabricated provisional prosthesis

Insertion of denture conversion (DC)

ACTIVE COMPARATOR

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

Device: DC (denture conversion) provisional prosthesis

Interventions

CAD-CAM fabricated provisional prosthesis DEVICE

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

CAD-CAM fabricated provisional prothesis

DC (denture conversion) provisional prosthesis DEVICE

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

Insertion of denture conversion (DC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• ITI Foundation: collaborator

Study Sites (1)

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

Pune, 411001, India

Location

Central Study Contacts

Silvia Rasi, Dr.

CONTACT

+41446343365; silvia.rasi@zzm.uzh.ch

Tabrez Lakha, Dr.

CONTACT

+919766675324; tabrezlakha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: As the placement of implants and the type of implant is clearly distinguishable and require different handling, blinding of the prosthodontist is not feasible. Patients are blinded to the type of implant received and to the type of procedure followed for the fabrication of the provisional prosthesis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The edentulous patients recruited in the study will be randomized into the following two groups: * Placement of tilted implants in the distal most position (group-Til) with straight implants in the anterior region * Placement of axial implants in the distal most position (group-Axl) with straight implants in the anterior region Subjects from the above groups will be further divided into following two sub-groups: * Immediate loading using denture conversion prosthesis (group DC) * Immediate loading using milled PMMA prosthesis (group CAD-CAM)

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: April 18, 2022
• Study Start: May 1, 2022
• Primary Completion: July 1, 2023
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

IN (1)