Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04971382
Collaborator
(none)
18
1
2
39
0.5

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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)
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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 Names:
  • 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 Names:
  • Curcumin (Curcuma longa)
  • Outcome Measures

    Primary Outcome Measures

    1. clinical outcome [change from baseline at 6 months]

      Assessment the gain in alveolar ridge buccolingual width

    Secondary Outcome Measures

    1. stability ["through study completion, an average of 1 year]

      Assessment of the primary implant stability Quotient in the regenerated bone

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 faculty of dentistry Ain shams university Cairo Egypt 11566

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Study Director: Hala A Abuelela, professor, faculty of dentistry . Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 21, 2021
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Ass.lecturer of oral medicine and periodontology, Ain Shams University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2021