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

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.

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue; Gingival Biotype
• Intervention / Treatment: Diagnostic test: volume survey

• Study Type: Observational
• Enrollment (Estimated): 56

Contacts and Locations

• Study Contact: Name: Ahmed Hamdy; Phone Number: +201061112512; Email: ahmed.esmaail@bue.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11234
    • Recruiting
    • Ahmed Hamdy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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:

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 Plan

How is the study designed?

Number of groups / cohorts

2

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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: British University In Egypt
• Investigators: Principal Investigator: AHMED HAMDY MAHMOUD MAHMOUD, British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: soft tissue volume
• Other Study ID Numbers: BritishUE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No