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

Recruiting

• Conditions: Gingival Biotype; Soft Tissue
• Interventions: Diagnostic Test: volume survey

• Registration Number: NCT06348823
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-25
• Study First Submitted: 2024-03-31
• Study First Submitted QC: 2024-03-31
• Status Verified: 2024-04
• Study First Posted: 2024-04-05
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-06
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
thick biotype group	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.
thin biotype group	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.

Primary Outcome Measures

Name	Time	Method
soft tissue volume - biotype correlation	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.

Trial Locations

Locations (1)

Ahmed Hamdy; 🇪🇬 Cairo, Egypt