Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

Alveolar Ridge Augmentation With Curcumin Combined With Xenograft After Piezoelectric Alveolar Ridge Splitting Surgery (A Randomized Controlled Clinical Trial)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Horizontal Alveolar Bone Loss
• Intervention / Treatment: Drug: Curcumin

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 Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: yasmine G Elbohy, Ass.lecturer; Phone Number: 01283881604; Email: yasmingamal@dent.asu.edu.eg
• Study Contact Backup: Name: Ahmed Amr, Ass.professor; Phone Number: 01222243314; Email: hmedmr@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Faculty of Dentistry Ain Shams University
    • Contact: hala abuelela, professor; Phone Number: 01002500182; Email: dr.halaabuelela@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome	Assessment the gain in alveolar ridge buccolingual width	change from baseline at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stability	Assessment of the primary implant stability Quotient in the regenerated bone	"through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: xenograft; curcumin; Piezoelectric; Alveolar Ridge Splitting
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: OMD2021-3-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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