- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06348823
Relationship Between Soft Tissue Volume and Gingival Phenotype: A Novel Classification System
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Hamdy
- Phone Number: +201061112512
- Email: ahmed.esmaail@bue.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 11234
- Recruiting
- Ahmed Hamdy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
This cross sectional observational clinical study will include ---- patients that will be recruited from the outpatient clinic of the department of Oral Medicine, Periodontology, and Diagnosis, Faculty of Dentistry, The British University in Egypt.
Demographic data of all patients will be collected. Patients will be clearly instructed about the purpose of this study and will give their consent by signing an informed consent.
The study will be started after being accepted by the faculty of Dentistry, The British University in Egypt Research Ethics Committee. The study tracks the guideline of the research ethical committee in line with the Helsinki Declaration of 1975.
Description
Inclusion Criteria:
- Adult patients in a healthy systemic condition who required comprehensive dental treatment.
- Both genders with age group > 18 years old.
- CBCT scans will be obtained as a part of the comprehensive dental treatment.
- Patients should approve to deliver a signature to a written consent after study nature explanation.
Exclusion Criteria:
- Patients with severe smoking habits >10 cig \ day.
- Pregnant females, decisional impaired individuals, Prisoners and handicapped patients.
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
- Patients with fillings or crowns in the central incisors.
- Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin),
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
thin biotype group
All subjects received oral hygiene instructions and, if needed, a dental cleaning of plaque and calculus.
After calibration using digital photographs, intraoral scans, and CBCT, one dentist, who was not involved in the screening phase to avoid any bias, obtained all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width).
Two test subjects were examined prior starting with enrollment and data collection.
|
All subjects received oral hygiene instructions and, if needed, a dental cleaning of plaque and calculus.
After calibration using digital photographs, intraoral scans, and CBCT, one dentist, who was not involved in the screening phase to avoid any bias, obtained all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width).
Two test subjects were examined prior starting with enrollment and data collection.
|
thick biotype group
All subjects received oral hygiene instructions and, if needed, a dental cleaning of plaque and calculus.
After calibration using digital photographs, intraoral scans, and CBCT, one dentist, who was not involved in the screening phase to avoid any bias, obtained all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width).
Two test subjects were examined prior starting with enrollment and data collection.
|
All subjects received oral hygiene instructions and, if needed, a dental cleaning of plaque and calculus.
After calibration using digital photographs, intraoral scans, and CBCT, one dentist, who was not involved in the screening phase to avoid any bias, obtained all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width).
Two test subjects were examined prior starting with enrollment and data collection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
soft tissue volume - biotype correlation
Time Frame: 3 months
|
The association between gingival biotype and buccal soft tissue volume will be analyzed.
Sensitivity and specificity of this novel method will be assessed.
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: AHMED HAMDY MAHMOUD MAHMOUD, British University in Egypt
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BritishUE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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