Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration

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

Detailed Description
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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

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

Conditions
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Bone Loss, Bone Lesion

Intervention / Treatment
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* Procedure: hyaluronic acid added to hydroxyapetite
* Procedure: Hydroxyapatite alone


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid + Hydroxyapatite<br>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<br>* 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 .<br>|
| Active Comparator: Hydroxyapatite alone<br>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<br>* 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 .<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone regenerarion, bone graft, hydroxyapatite