NCT07314034

Brief Summary

Participants with bite difficulties, smile dissatisfaction, and missing mandibular molars was rehabilitated using a fully digital, facially driven workflow. Integration of intraoral, facial, and CBCT data guided esthetic design, occlusion, and implant planning, resulting in precise alignment, functional occlusion, and esthetic restoration with veneers, zirconia crowns, TAD-assisted molar intrusion, and guided implants.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress75%
Jun 2024Dec 2026

Study Start

First participant enrolled

June 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

December 2, 2025

Last Update Submit

December 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implant Stability

    Clinical assessment: Absence of implant mobility assessed manually and using opposing instrument pressure. Radiographic assessment: Periapical radiographs using the paralleling technique to evaluate peri-implant bone levels. Success criteria: No progressive peri-implant radiolucency and marginal bone loss ≤ 1.5 mm during the first year, in accordance with Albrektsson et al. success criteria.

    12 months post-treatment

Interventions

Participants will receive full-mouth dental rehabilitation using advanced digital planning. Scans of the teeth, face, and jaw will guide treatment, which may include tooth movement with temporary devices, guided implant placement, and placement of custom veneers and crowns. This approach aims to restore bite function, improve smile esthetics, and ensure accurate, comfortable, and durable results.

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 20-45 years with partial or complete edentulism, bite dysfunction, or esthetic concerns requiring full-mouth rehabilitation. Participants must be medically fit for implant and minor orthodontic procedures, have adequate bone for implant placement or be candidates for TAD-assisted tooth movement, and be willing to undergo treatment using a fully digital, facially guided workflow. Both male and female patients capable of providing informed consent and complying with follow-up visits are eligible.

You may qualify if:

  • Adults aged 20-45 years with partial or complete edentulism requiring full-mouth rehabilitation.
  • Patients with bite dysfunction, malocclusion, or esthetic concerns suitable for digital workflow treatment.
  • Adequate bone volume for implant placement or candidates for TAD-assisted tooth movement.
  • Willingness to undergo treatment using a fully digital, facially guided workflow and comply with follow-up visits.
  • Ability to provide informed consent.

You may not qualify if:

  • Systemic conditions contraindicating implant or surgical procedures (e.g., uncontrolled diabetes, immunosuppression).
  • Active oral infections or untreated periodontal disease.
  • Heavy smokers (\>10 cigarettes/day) or substance abuse.
  • History of head and neck radiation therapy or bisphosphonate use.
  • Pregnancy or breastfeeding.
  • Inability to comply with treatment or follow-up protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Shibīn al Kawm, Menoufia, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

Mohammed A. El-Sawy, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor and principle investigator

Study Record Dates

First Submitted

December 2, 2025

First Posted

January 2, 2026

Study Start

June 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Up on reasonable request

Locations