Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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).

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Ain Shams University

Investigators

• Study Director: Ahmed Y Gamal, Professor; Faculty of dentistry- Ain shams university

More Information

• 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
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Curcumin; 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