Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions

Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions in the Presence of Hydroxyapatite, Nanohydroxyapatite and Combination of Nanohydroxyapatite and Platelet-rich Fibrin. A Clinical Study

recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone

Study Overview

• Status: Recruiting
• Conditions: Effects of the Elements
• Intervention / Treatment: Procedure: surgery

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amira Elkholly, PHD; Phone Number: Egypt +201001902507; Email: dr.amiraelkholly@yahoo.com
• Study Contact Backup: Name: Reham Hassan, Ass.prof; Phone Number: Egypt +201001542529; Email: reham-hassan@live.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Amira mohammed fathy Elkholly
    • Contact: Amira Elkholly, PHD; Phone Number: 01001902507; Email: dr.amiraelkholly@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient will be in range of 20-45 years of age at the time of treatment, having periapical lesions starting from 5mm or more in diameter related to failed endodontically treated single canaled teeth.

Exclusion Criteria:

• Any systemic debilitating disease such as:

Diabetes mellitus, renal disease, Liver disease or liver failure, Rheumatoid arthritis, Neoplastic disease or its treatment, chronic corticosteroid therapy, chronic hepatitis B or C , History of hepatitis A, pregnant females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: hydroxyappatite; hydroxyapatite powder used for enhancement of bone regeneration	Procedure: surgery; applying the graft inside bony defect after surgery
Other: nanohydroxyapatite; nanohydroxyapatite powder used for enhancement of bone regeneration	Procedure: surgery; applying the graft inside bony defect after surgery
Other: PRF with nanohydroxyapatite; platelet rich fibrin mixed with nanohydroxyapatite used for enhancement of bone regeneration	Procedure: surgery; applying the graft inside bony defect after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing of periapical lesion	change in size of bony defect	interappointment at 1 month, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 238

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No