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)
1 other identifier
interventional
20
1 country
1
Brief Summary
Evaluation of the effect of hyaluronic acid with hydroxyapatite versus hydroxyapatite alone on bone regeneration following enucleation of mandibular odontogenic cyst.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2023
CompletedFirst Posted
Study publicly available on registry
July 24, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedSeptember 13, 2023
July 1, 2023
10 months
July 8, 2023
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone density
It is assessed using CBCT to determine the density of bone after intervention
6 months
Secondary Outcomes (1)
postoperative pain
2 weeks
Study Arms (2)
Hyaluronic acid + Hydroxyapatite
EXPERIMENTALhyaluronic 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 alone
ACTIVE COMPARATORHydroxyapatite 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
Interventions
1. The procedure will be performed under complete aseptic condition, and the surgical field will be swabbed with povidone iodine solution before the operation . 2. Surgical procedure will be performed under local anesthesia (Articaine 4% with 1:100,000 adrenaline ) . 3. A full thickness mucoperiosteal flap will be reflected exposing the area of interest containing the lesion . 4. The pathological lesion will be exposed using rose head bur on low-speed handpiece under copious irrigation by normal saline . 5. The whole pathological tissues will be enucleated and sent for histopathological examination. 6. The cavity will be curetted again to remove any remaining tissues and irrigated with 0.9% normal saline . 7. hydroxyapetite with hyaluronic acid will be inserted in the bony cavity to initiate healing . 8. The flap will be repositioned and sutured with interrupted 3-0 Vicryl suture .
1. The procedure will be performed under complete aseptic condition, and the surgical field will be swabbed with povidone iodine solution before the operation . 2. Surgical procedure will be performed under local anesthesia (Articaine 4% with 1:100,000 adrenaline ) . 3. A full thickness mucoperiosteal flap will be reflected exposing the area of interest containing the lesion . 4. The pathological lesion will be exposed using rose head bur on low-speed handpiece under copious irrigation by normal saline . 5. The whole pathological tissues will be enucleated and sent for histopathological examination. 6. The cavity will be curetted again to remove any remaining tissues and irrigated with 0.9% normal saline . 7. hydroxyapetite will be inserted in the bony cavity to initiate healing . 8. The flap will be repositioned and sutured with interrupted 3-0 Vicryl suture .
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, 12311, Egypt
Related Publications (3)
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.
PMID: 27007721BACKGROUNDScariot 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.
PMID: 22041117BACKGROUNDAboulHosn 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.
PMID: 30729045BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Bachelor of Dental Surgery ( BDS )
Study Record Dates
First Submitted
July 8, 2023
First Posted
July 24, 2023
Study Start
October 1, 2023
Primary Completion
August 1, 2024
Study Completion
January 1, 2025
Last Updated
September 13, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share