Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

NCT ID: NCT04971382

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-03-01

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

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.

Conditions

Horizontal Alveolar Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

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

alveolar ridge splitting with use of particulate xenograft alone.

xenograft will be used alone after ridge splitting

Group Type: ACTIVE_COMPARATOR

Curcumin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Curcumin (Curcuma longa)

Eligibility 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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Yasmine Gamal

Ass.lecturer of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala A Abuelela, professor

Role: STUDY_DIRECTOR

faculty of dentistry . Ain Shams University

Locations

faculty of dentistry Ain shams university

Cairo, , Egypt

Countries

Egypt

Central Contacts

yasmine G Elbohy, Ass.lecturer

Role: CONTACT

yasmingamal@dent.asu.edu.eg

01283881604

Ahmed Amr, Ass.professor

Role: CONTACT

hmedmr@gmail.com

01222243314

Facility Contacts

hala abuelela, professor

Role: primary

dr.halaabuelela@hotmail.com

01002500182

Other Identifiers

OMD2021-3-

Identifier Type: -

Identifier Source: org_study_id