Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration

Bone Loss Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05957926
• Other study ID #: 2991
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Enas Eldaour, BSc.
• Phone: 01016676513
• Email: enas.fadel[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Bone Lesion
• Bone Loss
• Calcium Metabolism Disorders

Intervention

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 .
• 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 .

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density	It is assessed using CBCT to determine the density of bone after intervention	6 months
Secondary	postoperative pain	It is assessed by using visual analogue scale from 1-10	2 weeks