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Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration

Primary Purpose

Bone Loss, Bone Lesion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hyaluronic acid added to hydroxyapetite
Hydroxyapatite alone
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss focused on measuring bone regenerarion, bone graft, hydroxyapatite

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyaluronic acid + Hydroxyapatite

Hydroxyapatite alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bone density
It is assessed using CBCT to determine the density of bone after intervention

Secondary Outcome Measures

postoperative pain
It is assessed by using visual analogue scale from 1-10

Full Information

First Posted
July 8, 2023
Last Updated
September 11, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05957926
Brief Title
Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration
Official Title
Evaluation the Effect of Hyaluronic Acid With Hydroxyapatite Versus Hydroxyapatite Alone on Bone Regeneration Following Enucleation of Mandibular Odontogenic Cyst (Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Bone Lesion
Keywords
bone regenerarion, bone graft, hydroxyapatite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid + Hydroxyapatite
Arm Type
Experimental
Arm Description
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
Arm Title
Hydroxyapatite alone
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
hyaluronic acid added to hydroxyapetite
Intervention Description
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 .
Intervention Type
Procedure
Intervention Name(s)
Hydroxyapatite alone
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Bone density
Description
It is assessed using CBCT to determine the density of bone after intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
postoperative pain
Description
It is assessed by using visual analogue scale from 1-10
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enas Eldaour, BSc.
Phone
01016676513
Ext
+2
Email
enas.fadel@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha Tohamy, BSc.
Phone
01066534079
Ext
+2
Email
rasha.tohamy@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
12311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27007721
Citation
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.
Results Reference
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PubMed Identifier
22041117
Citation
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.
Results Reference
background
PubMed Identifier
30729045
Citation
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.
Results Reference
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Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration

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