Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading

January 27, 2024 updated by: yasmine Elsherbeeny, Ain Shams University

Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading: A Randomized Trial

This study presents a smart digital approach to design and construct a screw retained immediately loaded full arch implant supported bridge based on the pre-treatment complete denture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After intra oral scanning of the ridge form, implant positions, the denture is used to scan the intermaxillary relation and tooth positions and the fixed interim is designed and milled from PMMA. This technique is applicable when a single arch is treated or for bimaxillary implant rehabilitation cases. In this study 30 patients were grouped into two groups; group I in which a converted denture was made conventionally and Group II in which a converted denture was made digitally. General satisfaction, chair side working time, and esthetic outcome of the prostheses were recorded and quantified with a verbal rating scale following insertion of implant-supported prosthesis.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • -Nonsmokers
  • Free from any systemic disease
  • Non-bruxers
  • With sufficient quality and quantity of bone
  • Prepared to comply with the follow-up and maintenance program

Exclusion Criteria:

  • - Patients with bad oral hygiene.
  • Patients with limited mouth opening.
  • Vulnerable groups.
  • Uncooperative patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional denture conversion
a conventional denture conversion will be done following the conventional fabrication technique.
Procedure: conventional denture conversion
conventional workflow usually done to do immediate loading for full arch implant cases
Experimental: digital denture conversion
An alternative workflow for construction of the fixed interim requires impressions, model production, and jaw relation records then digitizing all these data then designing and milling the restoration.
Procedure: digital denture conversion
An alternative workflow for construction of the fixed interim requires impressions, model production, and jaw relation records then digitizing all these data then designing and milling the restoration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient general satisfaction questionnaire
Time Frame: through study completion within 6 months
General satisfaction with a verbal rating scale range from 0 to 5, as 0 denotes the lowest value (worst) and 5 the highest value (best), following insertion of implant-supported prosthesis.
through study completion within 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chair side working time questionnaire
Time Frame: through study completion within 6 months
the procedure working time with a verbal rating scale range from 0 to 5, as 0 denotes the lowest value (worst) and 5 the highest value (best), following insertion of implant-supported prosthesis.
through study completion within 6 months
esthetic satisfaction questionnaire
Time Frame: through study completion within 6 months
esthetic outcome of the prostheses with a verbal rating scale range from 0 to 5, as 0 denotes the lowest value (worst) and 5 the highest value (best), following insertion of implant-supported prosthesis.
through study completion within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Estimated)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-Rec IR 102305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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