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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05957926
Enrollment
20
Registered
2023-07-24
Start date
2023-10-01
Completion date
2025-01-01
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Lesion, Bone Loss

Keywords

bone regenerarion, bone graft, hydroxyapatite

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

Interventions

PROCEDUREhyaluronic acid added to hydroxyapetite

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 .

PROCEDUREHydroxyapatite alone

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 .

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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 .

Design outcomes

Primary

MeasureTime frameDescription
Bone density6 monthsIt is assessed using CBCT to determine the density of bone after intervention

Secondary

MeasureTime frameDescription
postoperative pain2 weeksIt is assessed by using visual analogue scale from 1-10

Countries

Egypt

Contacts

Primary ContactEnas Eldaour, BSc.
enas.fadel@dentistry.cu.edu.eg01016676513
Backup ContactRasha Tohamy, BSc.
rasha.tohamy@dentistry.cu.edu.eg01066534079

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026