MalocclusionNCT07314034
"Facially Driven Digital Full-Mouth Rehabilitation"
An observational study of Malocclusion, run by Menoufia University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Facially Driven, Fully Digital Full-Mouth Rehabilitation with Guided Implant Placement, TAD-Assisted Molar Intrusion, and Restorative Crowns/Veneers
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Shibīn al Kawm, Menoufia
Mohammed A. El-Sawy, 00201061314522, Dr_sawy@windowslive.com
About this study
Official title: Facially Driven Digital Workflow for Esthetic and Functional Full-mouth Rehabilitation
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.
Read the detailed description
This Prospective study describes the comprehensive digital management of patients presenting with anterior open bite, smile dissatisfaction, and missing mandibular molars. A 3D virtual patient model was created by integrating intraoral scans, facial scans, and CBCT imaging, enabling prosthetically driven planning for esthetic and functional outcomes. Treatment involved conservative anterior rehabilitation with lithium disilicate veneers, full-coverage monolithic zirconia crowns, TAD-assisted intrusion of extruded molars, and guided implant placement for missing mandibular molars. The fully digital, facially guided workflow allowed precise restoration positioning, occlusal harmony, and predictable functional and esthetic results, demonstrating the utility of integrated digital planning in complex full-mouth rehabilitation.
- Conditions
- Malocclusion
- Being tested
- Facially Driven, Fully Digital Full-Mouth Rehabilitation with Guided Implant Placement, TAD-Assisted Molar Intrusion, and Restorative Crowns/Veneers
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facially Driven, Fully Digital Full-Mouth Rehabilitation with Guided Implant Placement, TAD-Assisted Molar Intrusion, and Restorative Crowns/VeneersDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jun 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314034
- Sponsor's protocol ID
- ADMNF-0051
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facially Driven Digital Workflow for Esthetic and Functional Full-mouth Rehabilitation
- ClinicalTrials.gov ID
- NCT07314034
- Acronym / sponsor ID
- ADMNF-0051
- Conditions
- Malocclusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Prospective study describes the comprehensive digital management of patients presenting with anterior open bite, smile dissatisfaction, and missing mandibular molars. A 3D virtual patient model was created by integrating intraoral scans, facial scans, and CBCT imaging, enabling prosthetically driven planning for esthetic and functional outcomes. Treatment involved conservative anterior rehabilitation with lithium disilicate veneers, full-coverage monolithic zirconia crowns, TAD-assisted intrusion of extruded molars, and guided implant placement for missing mandibular molars. The fully digital, facially guided workflow allowed precise restoration positioning, occlusal harmony, and predictable functional and esthetic results, demonstrating the utility of integrated digital planning in complex full-mouth rehabilitation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facially Driven, Fully Digital Full-Mouth Rehabilitation with Guided Implant Placement, TAD-Assisted Molar Intrusion, and Restorative Crowns/VeneersParticipants 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. | Device | – |
Primary outcome
Implant Stability
Time frame: 12 months post-treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No. Up on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A. El-Sawy, PhD (00201061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability (time frame: 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.