Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment.

NCT06354374 | Recruiting

• 1 other identifier: 24-026
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions \& tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system.

Conditions

Soft Tissue Volume

Outcome Measures

Primary Outcomes (1)

• the relationship between soft tissue volume & tomographic alveolar ridge classes

  the relationship between soft tissue volume and tomographic alveolar ridge classes

  3 months

Interventions

volume survey DIAGNOSTIC_TEST

All subjects will receive oral hygiene instructions and, if needed. A dental cleaning of plaque and calculus. After calibration using digital photographs and digital intraoral scans, CBCT scans will be taken as a prerequisite for dental implant treatment protocol. one dentist who will not be involved in the screening phase will obtain all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width) to avoid any bias. After finishing data collection, a customized treatment plan for each patient will be performed and dental implant treatment will be completed for each patient.

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 350 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 guidelines 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.
• Patients should have at least a single missing tooth that requires dental implant placement.
• Healing period of 3 months after extraction prior to surgical procedures.
• 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 studying 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 on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
• Patients with infections either periodontally or periapically

Sponsors & Collaborators

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

Study Sites (1)

Ahmed Hamdy

Al Shorouk City, Cairo Governorate, 11837, Egypt

RECRUITING

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 9, 2024
• Study Start: February 22, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

EG (1)