NCT07393269

Brief Summary

This prospective controlled clinical trial evaluates the three-dimensional positional accuracy of implant-level impressions obtained using scannable healing abutments compared with conventional open-tray and closed-tray impression techniques in partially edentulous patients with unilateral free-end saddle situations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

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

July 2, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 24, 2026

Last Update Submit

January 31, 2026

Conditions

Keywords

Dental Impression TechniqueIntraoral ScanningPartial EdentulismDigital DentistryDental Implants

Outcome Measures

Primary Outcomes (1)

  • Three-dimensional implant positional accuracy (RMS deviation)

    Root mean square (RMS) deviation (µm) between test impressions and the open-tray reference model using 3D metrology software.

    Periprocedural (single assessment, 1 week after second-stage implant surgery)

Secondary Outcomes (1)

  • Comparison of implant positional accuracy between impression techniques

    Periprocedural (single assessment, 1 week after second-stage implant surgery)

Study Arms (3)

Scannable Healing Abutment Digital Impression

EXPERIMENTAL

Intraoral digital impression using scannable healing abutments and an intraoral scanner.

Procedure: Digital implant impression using scannable healing abutments

Open-Tray Conventional Impression

ACTIVE COMPARATOR

Conventional splinted open-tray implant impression using polyvinyl siloxane.

Procedure: Open-tray implant impression

Closed-Tray Conventional Impression

ACTIVE COMPARATOR

Conventional closed-tray implant impression using polyvinyl siloxane.

Procedure: Closed-tray implant impression

Interventions

Digital acquisition of implant position using intraoral scanning of scannable healing abutments following second-stage surgery.

Scannable Healing Abutment Digital Impression

Conventional open-tray implant-level impression using splinted impression copings and polyvinyl siloxane material.

Open-Tray Conventional Impression

Conventional closed-tray implant-level impression using transfer copings and polyvinyl siloxane material.

Closed-Tray Conventional Impression

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Partially edentulous patients with unilateral free-end saddle (Kennedy Class II)
  • Adequate bone for two implants
  • Good systemic health
  • Ability to provide informed consent

You may not qualify if:

  • Active periodontal disease
  • Poor oral hygiene
  • Parafunctional habits
  • Temporomandibular disorders
  • Heavy smoking (\>10 cigarettes/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 6, 2026

Study Start

July 2, 2025

Primary Completion

October 20, 2025

Study Completion

November 10, 2025

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. The data generated in this study include identifiable clinical and radiographic measurements that are specific to the study protocol and participants. De-identified aggregate data are reported in the published manuscript.

Locations