Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Horizontal Alveolar Bone Loss

Intervention / Treatment
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* Drug: Curcumin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curcumin combined with particulate xenograft.<br>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<br>* 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<br>* Other names: Curcumin (Curcuma longa);|
| Active Comparator: alveolar ridge splitting with use of particulate xenograft alone.<br>xenograft will be used alone after ridge splitting | Drug: Curcumin<br>* 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<br>* Other names: Curcumin (Curcuma longa);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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curcumin, xenograft, Piezoelectric, Alveolar Ridge Splitting