Bone LossNCT05957926
Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration
A study testing hyaluronic acid added to hydroxyapetite and Hydroxyapatite alone in people with Bone Loss and Bone Lesion, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of the effect of hyaluronic acid with hydroxyapatite versus hydroxyapatite alone on bone regeneration following enucleation of mandibular odontogenic cyst. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Bone Lesion
- What is being tested?
- hyaluronic acid added to hydroxyapetite and Hydroxyapatite alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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)
Evaluation of the effect of hyaluronic acid with hydroxyapatite versus hydroxyapatite alone on bone regeneration following enucleation of mandibular odontogenic cyst.
Read the 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
- Conditions
- Bone Loss, Bone Lesion
- Being tested
- hyaluronic acid added to hydroxyapetite, Hydroxyapatite alone
- Keywords
- bone regenerarion, bone graft, hydroxyapatite
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid added to hydroxyapetiteProcedure or surgery
- 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 aloneProcedure or surgery
- 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 .
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid + Hydroxyapatite | Experimental | 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 Receives: Procedure: hyaluronic acid added to hydroxyapetite |
| Hydroxyapatite alone | Active comparator | 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 Receives: Procedure: Hydroxyapatite alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
It is assessed using CBCT to determine the density of bone after intervention
Measured: 6 months
Secondary outcomes (1)
postoperative pain
It is assessed by using visual analogue scale from 1-10
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Fadel Said Aldaour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957926
- Sponsor's protocol ID
- 2991
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27007721Scariot 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.
PubMed 22041117AboulHosn 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.
PubMed 30729045
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05957926
- Acronym / sponsor ID
- 2991
- Conditions
- Bone Loss, Bone Lesion
- Keywords
- bone regenerarion, bone graft, hydroxyapatite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid + Hydroxyapatite | Experimental | Procedure: hyaluronic acid added to hydroxyapetitehyaluronic 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 comparator | Procedure: Hydroxyapatite aloneHydroxyapatite 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acid added to hydroxyapetite1. 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 . | Procedure or surgery | Hyaluronic acid + Hydroxyapatite |
| Hydroxyapatite alone1. 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 . | Procedure or surgery | Hydroxyapatite alone |
Primary outcome
Bone density
Time frame: 6 months
It is assessed using CBCT to determine the density of bone after intervention
1 secondary outcome
postoperative pain
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 27007721Zhao 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.
- Background: PubMed 22041117Scariot 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.
- Background: PubMed 30729045AboulHosn 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.
- Individual participant dataSharing planned: No
Related trials for Bone Loss
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Active, not recruiting
Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Osteopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronic acid added to hydroxyapetite and Hydroxyapatite alone in people with Bone Loss and Bone Lesion, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enas Eldaour, BSc. (01016676513 ext. +2, enas.fadel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957926, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.