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

Complete Edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06233552
• Other study ID #: FDASU-Rec IR 102305
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complete Edentulism

Intervention

Procedure:
• conventional denture conversion
conventional workflow usually done to do immediate loading for full arch implant cases
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient general satisfaction questionnaire	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	chair side working time questionnaire	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
Secondary	esthetic satisfaction questionnaire	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