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

NCT06348823 | Recruiting

• 1 other identifier: BritishUE
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Biotype; Soft Tissue

Keywords

soft tissue volume

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

volume survey DIAGNOSTIC_TEST

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; thin biotype group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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),

Sponsors & Collaborators

• Ain Shams University: lead
• British University In Egypt: collaborator

Study Sites (1)

Ahmed Hamdy

Cairo, Cairo Governorate, 11234, Egypt

RECRUITING

Study Officials

• AHMED HAMDY MAHMOUD MAHMOUD

  British University In Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Hamdy

CONTACT

+201061112512; ahmed.esmaail@bue.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: February 25, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-04

Locations

EG (1)