Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP

NCT06382974 | Not Yet Recruiting

• 1 other identifier: 3-3-14
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects.

Conditions

Infection; Bone Loss

Keywords

bone regeneration; bone graft; volumetric analysis

Outcome Measures

Primary Outcomes (1)

• The Rate of shrinkage of the residual bone defect

  the shrinkage of the residual bone defects after bone grafting, measured from the following formula: pre-operative cyst volume - 3/6 months post-operative defect volume/pre-operative cyst volume x 100%. it will be measured radiographically using CBCT through manual segmentation

  3 moths post-operatively and 6 months post-operatively

Secondary Outcomes (1)

• Incidence of Inflammation at the grafted site

  1 week post-operatively, 3 months post-operatively and 6 months post-operatively

Study Arms (1)

bone grafting using atorvastatin combined with beta-TCP

EXPERIMENTAL

the 10 volunteers will undergo cyst enucleation followed by filling the residual bone defects with atorvastatin combined with beta-TCP in the ratio of 0.1 mg: 14 mg.

Procedure: Cyst enucleation and bone grafting

Interventions

Cyst enucleation and bone grafting PROCEDURE

cyst enucleation followed by bone grafting the residual bone defects using Atorvastatin combined with β-TCP.

Also known as: Bone grafting

bone grafting using atorvastatin combined with beta-TCP

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients
• Patients 18 to 40 years old
• Radicular cyst with a maximum diameter from 1.5 to 4.0 cm;
• Focal teeth were preserved with root canal treatment;
• No previous surgical treatment of the cyst site;
• No evidence of acute inflammation;
• In good physical status and oral health;
• Regular attendance at control visits

You may not qualify if:

• Patients \< 17 years old
• Radicular cyst with a maximum diameter \< 1.5 cm.
• Pregnancy or lactation
• Aggregate systemic pathologies such as diabetes, thyroid disorders, and bone metabolism diseases, among others;
• Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with the metabolism of bone;
• Patients with uncontrolled periodontal conditions, endodontic conditions, and other oral disorders;
• Heavy smokers (10 cigarettes/day or more)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Links

• first in-vivo study to test the methodology adopted in this research
• the clinical study methodology adopted in this research

MeSH Terms

Conditions

Infections; Bone Diseases, Metabolic

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Salah Yassin

  department of oral and maxillofacial surgery, cairo university

  STUDY DIRECTOR

Central Study Contacts

Yara Mahmoud

CONTACT

01100764737; yara.mahmoud@dentistry.cu.edu.eg

Mohamed Mosa

CONTACT

mohamed.mosa@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post-graduate master student

Model Details: A case series study.

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)