NCT04971382

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

July 5, 2021

Last Update Submit

July 20, 2021

Conditions

Horizontal Alveolar Bone Loss

Keywords

curcuminxenograftPiezoelectricAlveolar Ridge Splitting

Outcome Measures

Primary Outcomes (1)

  • clinical outcome

    Assessment the gain in alveolar ridge buccolingual width

    change from baseline at 6 months

Secondary Outcomes (1)

  • stability

    "through study completion, an average of 1 year

Study Arms (2)

curcumin combined with particulate xenograft.

EXPERIMENTAL

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

alveolar ridge splitting with use of particulate xenograft alone.

ACTIVE COMPARATOR

xenograft will be used alone after ridge splitting

Drug: Curcumin

Interventions

CurcuminDRUG

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

Also known as: Curcumin (Curcuma longa)
alveolar ridge splitting with use of particulate xenograft alone.curcumin combined with particulate xenograft.

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry Ain shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Interventions

Curcuminturmeric extract

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Hala A Abuelela, professor

    faculty of dentistry . Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

yasmine G Elbohy, Ass.lecturer

CONTACT

01283881604yasmingamal@dent.asu.edu.eg

Ahmed Amr, Ass.professor

CONTACT

01222243314hmedmr@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.lecturer of oral medicine and periodontology

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 21, 2021

Study Start

December 1, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2025

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)