Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

Horizontal Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04971382
• Other study ID #: OMD2021-3-
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: July 2021
• Source: Ain Shams University
• Contact: yasmine G Elbohy, Ass.lecturer
• Phone: 01283881604
• Email: yasmingamal[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Horizontal Alveolar Bone Loss

Intervention

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

Locations

Country	Name	City	State
Egypt	faculty of dentistry Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcome	Assessment the gain in alveolar ridge buccolingual width	change from baseline at 6 months
Secondary	stability	Assessment of the primary implant stability Quotient in the regenerated bone	"through study completion, an average of 1 year