Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration

Evaluation the Effect of Hyaluronic Acid With Hydroxyapatite Versus Hydroxyapatite Alone on Bone Regeneration Following Enucleation of Mandibular Odontogenic Cyst (Randomized Clinical Trial)

Evaluation of the effect of hyaluronic acid with hydroxyapatite versus hydroxyapatite alone on bone regeneration following enucleation of mandibular odontogenic cyst.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Loss; Bone Lesion
• Intervention / Treatment: Procedure: hyaluronic acid added to hydroxyapetite; Procedure: Hydroxyapatite alone

Detailed Description

During cyst enucleation , There's resultant decrease in bone density especially in large defects .Therefore, it may be needed for a bone grafts and bone regenerative materials to improve quality of bone .The rationale is to evaluate hyaluronic acid with hydroxyapatite as a bone quality improvement material following cyst enucleation, which would provide significant bone regeneration. Hydroxyapatite is inorganic component of bone tissue used as bone graft, scaffolds, filler and cement for repair and regeneration of bone defect , and it is stimulate bone remodeling by generating surface active moieties or cell signaling process while Hyaluronic acid and it's derivatives has been widely used for bone regeneration and it has a good potential for osteogenesis and mineralization

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enas Eldaour, BSc.; Phone Number: +2 01016676513; Email: enas.fadel@dentistry.cu.edu.eg
• Study Contact Backup: Name: Rasha Tohamy, BSc.; Phone Number: +2 01066534079; Email: rasha.tohamy@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patient in need of cyst removal .
• Both genders aged between 18-50 years .
• Size of lesion is ≤ 4 cm .
• Patients free from any systemic disease that may affect bone healing .

Exclusion criteria :

• Heavy smokers , alcohol intake .
• Poor oral hygiene .
• Patient with systemic disease that may affect bone healing .
• Pregnant women.
• Patient who are currently or have been under treatment using chemotherapy or radiotherapy
• Uncooperative patient .

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid + Hydroxyapatite; hyaluronic acid is used for bone regeneration and it has a good potential for osteogenesis and mineralization so it can have synergistic effect when used with hydroxyapatite for bone regeneration after cyst enucleation	Procedure: hyaluronic acid added to hydroxyapetite; The procedure will be performed under complete aseptic condition, and the surgical field will be swabbed with povidone iodine solution before the operation .; Surgical procedure will be performed under local anesthesia (Articaine 4% with 1:100,000 adrenaline ) .; A full thickness mucoperiosteal flap will be reflected exposing the area of interest containing the lesion .; The pathological lesion will be exposed using rose head bur on low-speed handpiece under copious irrigation by normal saline .; The whole pathological tissues will be enucleated and sent for histopathological examination.; The cavity will be curetted again to remove any remaining tissues and irrigated with 0.9% normal saline .; hydroxyapetite with hyaluronic acid will be inserted in the bony cavity to initiate healing .; The flap will be repositioned and sutured with interrupted 3-0 Vicryl suture .
Active Comparator: Hydroxyapatite alone; Hydroxyapatite is inorganic component of bone tissue used as bone graft, scaffolds, filler and cement for repair and regeneration of bone defect , and it stimulates bone remodeling by generating surface active moieties or cell signaling process	Procedure: Hydroxyapatite alone; The procedure will be performed under complete aseptic condition, and the surgical field will be swabbed with povidone iodine solution before the operation .; Surgical procedure will be performed under local anesthesia (Articaine 4% with 1:100,000 adrenaline ) .; A full thickness mucoperiosteal flap will be reflected exposing the area of interest containing the lesion .; The pathological lesion will be exposed using rose head bur on low-speed handpiece under copious irrigation by normal saline .; The whole pathological tissues will be enucleated and sent for histopathological examination.; The cavity will be curetted again to remove any remaining tissues and irrigated with 0.9% normal saline .; hydroxyapetite will be inserted in the bony cavity to initiate healing .; The flap will be repositioned and sutured with interrupted 3-0 Vicryl suture .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density	It is assessed using CBCT to determine the density of bone after intervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	It is assessed by using visual analogue scale from 1-10	2 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Zhao N, Wang X, Qin L, Zhai M, Yuan J, Chen J, Li D. Effect of hyaluronic acid in bone formation and its applications in dentistry. J Biomed Mater Res A. 2016 Jun;104(6):1560-9. doi: 10.1002/jbm.a.35681. Epub 2016 Apr 9.
• Scariot R, da Costa DJ, Rebellato NL, Muller PR, Gugisch RC. Treatment of a large dentigerous cyst in a child. J Dent Child (Chic). 2011 Jul;78(2):111-4.
• AboulHosn M, Noujeim Z, Nader N, Berberi A. Decompression and Enucleation of a Mandibular Radicular Cyst, Followed by Bone Regeneration and Implant-Supported Dental Restoration. Case Rep Dent. 2019 Jan 9;2019:9584235. doi: 10.1155/2019/9584235. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 8, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: bone graft; hydroxyapatite; bone regenerarion
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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