NCT06233552

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

December 18, 2023

Last Update Submit

January 27, 2024

Conditions

Keywords

immediate loadingdenture conversionfull arch implant rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • chair side working time questionnaire

    through study completion within 6 months

  • esthetic satisfaction questionnaire

    through study completion within 6 months

Study Arms (2)

conventional denture conversion

ACTIVE COMPARATOR

a conventional denture conversion will be done following the conventional fabrication technique.

Procedure: conventional denture conversion

digital denture conversion

EXPERIMENTAL

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

Interventions

conventional workflow usually done to do immediate loading for full arch implant cases

conventional 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.

digital denture conversion

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at the prosthodontics department, faculty of dentisrty

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 31, 2024

Study Start

March 1, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations