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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06348823
Other study ID # BritishUE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 25, 2024
Est. completion date October 2024

Study information

Verified date April 2024
Source Ain Shams University
Contact Ahmed Hamdy
Phone +201061112512
Email ahmed.esmaail@bue.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Different classifications to describe alveolar ridge defects have been published over the past years but no single classification has been developed concerning soft tissue volume around teeth or dental implants. Moreover, while several studies investigated the effect of various augmentation techniques and materials on soft tissue volume change and volume stability there is a real gap of knowledge regarding how to evaluate the available soft tissue volume and when to consider it sufficient or deficient which would definitely improve clinical decision making and treatment planing. Therefore, our primary aim was to assess the application of a novel classification system based on the correlation between buccal soft tissue volume and gingival biotypes and, also to assess the sensitivity of such novel method.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date October 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult patients in a healthy systemic condition who required comprehensive dental treatment. 2. Both genders with age group > 18 years old. 3. CBCT scans will be obtained as a part of the comprehensive dental treatment. 4. Patients should approve to deliver a signature to a written consent after study nature explanation. Exclusion Criteria: 1. Patients with severe smoking habits >10 cig \ day. 2. Pregnant females, decisional impaired individuals, Prisoners and handicapped patients. 3. Patients having poor oral hygiene or not wanting to carry out oral hygiene measures. 4. Patients with fillings or crowns in the central incisors. 5. Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin),

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
volume survey
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.

Locations

Country Name City State
Egypt Ahmed Hamdy Cairo

Sponsors (2)

Lead Sponsor Collaborator
Ain Shams University British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary soft tissue volume - biotype correlation 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
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