Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044417
• Other study ID #: FER16 21-M
• Status: Completed
• Phase: Phase 4
• Start date: August 25, 2016
• Est. completion date: October 3, 2018

Study information

• Verified date: August 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 3, 2018
• Est. primary completion date: May 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• currettage
open flap debridement

Drug:
• curcumin simvastatin paste
Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.
• EDTA root conditioning
EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical score	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.	change from base line to 6 months