Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration

September 11, 2023 updated by: Enas Fadel Said Aldaour, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 12311
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic acid + Hydroxyapatite
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
  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 .
Active Comparator: Hydroxyapatite alone
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
  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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density
Time Frame: 6 months
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
Time Frame: 2 weeks
It is assessed by using visual analogue scale from 1-10
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

July 8, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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