- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314034
"Facially Driven Digital Full-Mouth Rehabilitation"
Facially Driven Digital Workflow for Esthetic and Functional Full-mouth Rehabilitation
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohammed A. El-Sawy, PhD
- Phone Number: 00201061314522
- Email: Dr_sawy@windowslive.com
Study Locations
-
-
Menoufia
-
Shibīn al Kawm, Menoufia, Egypt
- Recruiting
- Faculty of Dentistry
-
Contact:
- Mohammed A. El-Sawy
- Phone Number: 00201061314522
- Email: Dr_sawy@windowslive.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
12 months post-treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADMNF-0051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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