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Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

Primary Purpose

Horizontal Alveolar Bone Loss

Status
Not yet recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Curcumin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Horizontal Alveolar Bone Loss focused on measuring curcumin, xenograft, Piezoelectric, Alveolar Ridge Splitting

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • faculty of dentistry Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

curcumin combined with particulate xenograft.

alveolar ridge splitting with use of particulate xenograft alone.

Arm Description

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

xenograft will be used alone after ridge splitting

Outcomes

Primary Outcome Measures

clinical outcome
Assessment the gain in alveolar ridge buccolingual width

Secondary Outcome Measures

stability
Assessment of the primary implant stability Quotient in the regenerated bone

Full Information

First Posted
July 5, 2021
Last Updated
July 20, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04971382
Brief Title
Alveolar Ridge Augmentation With Curcumin Combined With Xenograft
Official Title
Alveolar Ridge Augmentation With Curcumin Combined With Xenograft After Piezoelectric Alveolar Ridge Splitting Surgery (A Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horizontal Alveolar Bone Loss
Keywords
curcumin, xenograft, Piezoelectric, Alveolar Ridge Splitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
curcumin combined with particulate xenograft.
Arm Type
Experimental
Arm Description
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
Arm Title
alveolar ridge splitting with use of particulate xenograft alone.
Arm Type
Active Comparator
Arm Description
xenograft will be used alone after ridge splitting
Intervention Type
Drug
Intervention Name(s)
Curcumin
Other Intervention Name(s)
Curcumin (Curcuma longa)
Intervention Description
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
Primary Outcome Measure Information:
Title
clinical outcome
Description
Assessment the gain in alveolar ridge buccolingual width
Time Frame
change from baseline at 6 months
Secondary Outcome Measure Information:
Title
stability
Description
Assessment of the primary implant stability Quotient in the regenerated bone
Time Frame
"through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yasmine G Elbohy, Ass.lecturer
Phone
01283881604
Email
yasmingamal@dent.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Amr, Ass.professor
Phone
01222243314
Email
hmedmr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala A Abuelela, professor
Organizational Affiliation
faculty of dentistry . Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
faculty of dentistry Ain shams university
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hala abuelela, professor
Phone
01002500182
Email
dr.halaabuelela@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

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