NCT05948254

Brief Summary

A triple function scan Body were done on healed dental implant, thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits. In this technique, scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

May 11, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
Last Updated

July 17, 2023

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

July 10, 2023

Last Update Submit

July 10, 2023

Conditions

Keywords

Jaw relationScan bodyFull arch dental implants

Outcome Measures

Primary Outcomes (1)

  • percentage of consistency in simultaneous contacts in maximal intercuspal position

    At 2 months follow up after final prostheses delivery, a frontal photo was taken and an intra oral scan was made for each patient in order to assess the degree of consistency between initial virtual design and reality using Exocad Software, The intra oral Scan of the full arch restoration is inserted into Exocad Software and the interocclusal contacts for all teeth were detected, classifying them in a dichotomy variable (yes/no) contact or not per tooth.

    2 months following the final prosthesis

Study Arms (1)

Triple Function Scan Body

OTHER

Full arch implants were placed, a triple function scan Body and thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits. Scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration.

Procedure: Triple function scan body

Interventions

The scan bodies were used to scan the implant position, Jaw registration and facial scan alignment, First of all scan bodies were selected according to vertical dimension of occlusion, then the emergence profile together with the selected scan body were scanned,All scan bodies were then removed from the patient mouth except one or even two that were scanned in the jaw scan step, this scan body was utilized as a stopper, the patient was asked to bite until the scan body came in contact with the lower or upper teeth in case of edentulous upper or lower arch respectively, scan body in place (in the same orientation of the previous jaw scan ) provided that at least the tip of the scan body appeared when the patient is asked to smile which would be used as a common area so that the intra oral scanner can relate the jaw scan to the lips and face.

Triple Function Scan Body

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patient had at least one edentulous arch with at least 5 osseointegrated implants with healing period of 3 months after surgical procedure.
  • Implants are stable
  • Systemically free

You may not qualify if:

  • Smokers
  • Uncooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Doaa Adel-Khattab, PhD

    Associate Professor Faculty of Dentistry, Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Triple Function Scan Body
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 17, 2023

Study Start

May 11, 2022

Primary Completion

April 24, 2023

Study Completion

May 31, 2023

Last Updated

July 17, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations