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Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

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ClinicalTrials.gov Identifier: NCT04971382
Recruitment Status : Not yet recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Yasmine Gamal, Ain Shams University

Brief Summary:
A study was performed to investigate the effect of curcumin on the osteogenic differentiation of human periodontal ligament stem cells (hPDLSCs) and its underlying potential mechanism. The Results was that Curcumin at an appropriate concentration had no cytotoxicity and could promote osteogenic differentiation of the hPDLSCs

Condition or disease Intervention/treatment Phase
Horizontal Alveolar Bone Loss Drug: Curcumin Phase 4

Detailed Description:

Patients will be selected from the outpatient clinic of Oral Medicine, Periodontology and Oral diagnosis Department, Faculty of Dentistry, Ain Shams University. The purpose of the study will be explained to all patients and an informed consent will be signed before the conduction of the study .The faculty research ethics committee will review the proposal.

The study will be conducted in the form of Patient Intervention Comparative Outcome (PICO) question (Patient "P", Intervention "I", Comparative "C", Outcome "O"). (Stone 2002) "P": Patient in the study will have enough alveolar ridge height ,suffering from missing from 1 to 3 upper maxillary anterior and /or premolar with insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement. The minimum BL width included in the study will be 4 mm. "I": Ridge splitting with interposition grafting with curcumin and particulate xenograft grafting. "C":Alveolar ridge splitting with interposition grafting with use of particulate xenograft alone without curcumin . "O":Clinical and radiographic outcome.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alveolar Ridge Augmentation With Curcumin Combined With Xenograft After Piezoelectric Alveolar Ridge Splitting Surgery (A Randomized Controlled Clinical Trial)
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: curcumin combined with particulate xenograft.

Curcumin will be used in combination with xenograft after ridge splitting surgery

Curcumin is widely used in medicine due to medicinal properties, cost-effectiveness, and simple extraction from a turmeric plant that grows in different regions in the world. Recent evidences have shown that curcumin possesses multiple biological activities and pharmacological properties including anti-inflammation , antioxidation , anticancer , antimicrobial , and free radical scavenger effects

Drug: Curcumin
Curcumin (1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione) or diferuloylmethane is an important bioactive constituent and hydrophobic polyphenol that isolated from the rhizome of the turmeric plant (Curcuma longa) . Curcumin will be used in combination with xenograft after ridge splitting surgery
Other Name: Curcumin (Curcuma longa)

Active Comparator: alveolar ridge splitting with use of particulate xenograft alone.
xenograft will be used alone after ridge splitting
Drug: Curcumin
Curcumin (1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione) or diferuloylmethane is an important bioactive constituent and hydrophobic polyphenol that isolated from the rhizome of the turmeric plant (Curcuma longa) . Curcumin will be used in combination with xenograft after ridge splitting surgery
Other Name: Curcumin (Curcuma longa)




Primary Outcome Measures :
  1. clinical outcome [ Time Frame: change from baseline at 6 months ]
    Assessment the gain in alveolar ridge buccolingual width


Secondary Outcome Measures :
  1. stability [ Time Frame: "through study completion, an average of 1 year ]
    Assessment of the primary implant stability Quotient in the regenerated bone



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female with age range 25-45 years.
  • Patient with enough alveolar ridge height, suffering from missing single or multiple maxillary anterior and /or premolar with insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement. The minimum BL width included in the study will be 4-5 mm to facilitate ridge splitting and expansion.
  • Systemically free from any diseases as evidenced by Burket's oral medicine health history questionnaire.
  • Patient available during follow up periods.

Exclusion Criteria:

  • Smokers.
  • Pregnant and breast feeding females.
  • Patient unwilling to comply to oral hygienic instructions.
  • Patients under any medication or medical condition that affect the bone quality.
  • Vulnerable groups. (e.g decisions impaired individual).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971382


Contacts
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Contact: yasmine G Elbohy, Ass.lecturer 01283881604 yasmingamal@dent.asu.edu.eg
Contact: Ahmed Amr, Ass.professor 01222243314 hmedmr@gmail.com

Locations
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Egypt
faculty of dentistry Ain shams university
Cairo, Egypt, 11566
Contact: hala abuelela, professor    01002500182    dr.halaabuelela@hotmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Hala A Abuelela, professor faculty of dentistry . Ain Shams University
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Responsible Party: Yasmine Gamal, Ass.lecturer of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04971382    
Other Study ID Numbers: OMD2021-3-
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yasmine Gamal, Ain Shams University:
curcumin
xenograft
Piezoelectric
Alveolar Ridge Splitting
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action