Relationship Between Soft Tissue Volume and Gingival Phenotype: A Novel Classification System

Soft Tissue Clinical Trial

Official title:

Relationship Between Soft Tissue Volume and Gingival Phenotype: A Novel Classification System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348823
• Other study ID #: BritishUE
• Status: Recruiting
• 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
• 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),

Related Conditions & MeSH terms

• Gingival Biotype
• Soft Tissue

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