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Trial record 23 of 167 for:    Curcumin | curcumin

Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

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ClinicalTrials.gov Identifier: NCT04044417
Recruitment Status : Completed
First Posted : August 5, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Farouk Mohamed Hussein Elsobky, Ain Shams University

Brief Summary:
Among the root conditioning materials is the Ethylenediaminetetraacetic acid (EDTA). EDTA exposes the collagen fibers on dentin surfaces and also enhances early cell colonization. Statins have an anti-inflammatory effect, inhibit the bone resorption and stimulate the bone formation. Curcumin is effective in preventing periodontal disease destruction by targeting both bacteria and host inflammatory cells. Curcumin has anti- inflammatory, antioxidant, anticarcinogenic, antiviral, and antimicrobial functions. This study will be carried out to examine the effect of simvastatin-curcumin paste following EDTA root surface etching when used in conjunction with open flap debridement treating deep periodontal pockets (suggesting that it may have positive effect)

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: currettage Drug: curcumin simvastatin paste Drug: EDTA root conditioning Phase 4

Detailed Description:
The present study entailed thirty patients having stage II or stage III, Grade A periodontitis with 30 intrabony defects. Patients were divided into three groups; group I was subjected to open flap debridement only. Group II was subjected to open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). Group III was subjected to open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin-simvastatin paste .Group III received curcumin-simvastatin paste after debridement and 24 % EDTA. The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Curcumin-Simvastatin Release Profile in the Gingival Crevicular Fluid Following EDTA Root Surface Etching in the Surgical Treatment of Intrabony Periodontal Defects - A Biochemical and Clinical Study
Actual Study Start Date : August 25, 2016
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : October 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: open flap debridement only
surgical treatment of periodontal defects
Procedure: currettage
open flap debridement
Other Name: surgical treatment of periodontal defects

Active Comparator: curcumin and simvastatin
open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
Procedure: currettage
open flap debridement
Other Name: surgical treatment of periodontal defects

Drug: curcumin simvastatin paste
Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.
Other Name: open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

Active Comparator: EDTA, curcumin and simvastatin
open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
Procedure: currettage
open flap debridement
Other Name: surgical treatment of periodontal defects

Drug: curcumin simvastatin paste
Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.
Other Name: open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

Drug: EDTA root conditioning
EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid
Other Name: open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).




Primary Outcome Measures :
  1. clinical score [ Time Frame: change from base line to 6 months ]
    Probing depth (PD): evaluate the average reduction in probing depth measured in millimeters. Reduction in probing depth indicates that EDTA, simvastatin, and curcumin have positive effects in treatment.



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient suffering at least a single posterior 2-3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥3 mm, intrabony component ≥3 mm, plaque index ≤1 (Sillness and Loe, 1964) and sulcus bleeding index ≤1 (Mühlemann & Son, 1971). All these criteria were determined after phase I conventional periodontal therapy.
  • Systemically healthy as evidenced by burket's oral medicine health history question questionnaire (Glick et al., 2008).
  • Patients available during follow-up periods

Exclusion Criteria:

  • Smoking
  • Patient unwilling to comply with periodontal hygienic instructions
  • Patients under any long-term chronic medication
  • Vulnerable individuals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044417


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Ahmed Y Gamal, Professor Faculty of dentistry- Ain shams university

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Responsible Party: Eman Farouk Mohamed Hussein Elsobky, demonstrator of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04044417     History of Changes
Other Study ID Numbers: FER16 21-M
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Farouk Mohamed Hussein Elsobky, Ain Shams University:
periodontitis
curcumin
simvastatin
EDTA
Additional relevant MeSH terms:
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Curcumin
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Edetic Acid
Simvastatin
Pentetic Acid
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Antidotes
Protective Agents