Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05957926
Other study ID # 2991
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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 .

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04043286 - The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels N/A
Recruiting NCT03046147 - The Effect of Roux-en-Y Gastric Bypass on Bone Turnover N/A
Completed NCT01292395 - Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency N/A
Completed NCT00485953 - Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy Phase 4
Completed NCT00674453 - The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation Phase 2
Completed NCT00181584 - Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer Phase 2
Withdrawn NCT04380155 - Cycling Duration and Bone Markers in in Active Young Adults N/A
Active, not recruiting NCT04779216 - Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa Phase 3
Completed NCT05371418 - Comparative Clinical and Radiographical Evaluation of Treatment of Angular Bone Defect Related to Over Erupted Tooth Using GTR Followed by Orthodontic Intrusion Versus Orthodontic Intrusion Followed by GTR N/A
Not yet recruiting NCT04345250 - Bone Response to Exercise and Energy Restriction in Young Adults N/A
Active, not recruiting NCT05405894 - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Active, not recruiting NCT05301400 - Marginal Bone Loss in Single Implant Restaurations With Different Methods N/A
Recruiting NCT04983758 - 20-year Implant Survival in Periodontally Healthy and Compromised Patients
Recruiting NCT04713774 - Bone Density and Vascular Calcifications Evolution After Renal Transplant
Completed NCT04279392 - Healthy Body, Healthy Bones After Bariatric Surgery Trial Phase 1/Phase 2
Completed NCT04332679 - Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes N/A
Completed NCT05721014 - Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health N/A
Recruiting NCT04883502 - Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
Not yet recruiting NCT05066815 - Evaluation of Crestal Bone Loss Around Short Dental Implants As Affected By Two Suprastructure Materials N/A
Completed NCT03292146 - Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study Phase 3