Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

Phase 4

Completed

• Conditions: Periodontitis
• Interventions: Procedure: currettage; Drug: curcumin simvastatin paste; Drug: EDTA root conditioning

• Registration Number: NCT04044417
• Lead Sponsor: 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)

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 Timeline

• Study Start: 2016-08-25
• Primary Completion: 2018-05-05
• Study Completion: 2018-10-03
• Status Verified: 2019-08
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-04
• Study First Posted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open flap debridement only	currettage	surgical treatment of periodontal defects
curcumin and simvastatin	currettage	open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
curcumin and simvastatin	curcumin simvastatin paste	open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
EDTA, curcumin and simvastatin	currettage	open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
EDTA, curcumin and simvastatin	curcumin simvastatin paste	open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
EDTA, curcumin and simvastatin	EDTA root conditioning	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

Name	Time	Method
clinical score	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.