Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

NCT ID: NCT04044417

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-25
• Study Completion Date: 2018-10-03

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

open flap debridement only

surgical treatment of periodontal defects

Group Type: PLACEBO_COMPARATOR

currettage

Intervention Type: PROCEDURE

open flap debridement

curcumin and simvastatin

open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

Group Type: ACTIVE_COMPARATOR

currettage

Intervention Type: PROCEDURE

open flap debridement

curcumin simvastatin paste

Intervention Type: DRUG

Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.

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).

Group Type: ACTIVE_COMPARATOR

currettage

Intervention Type: PROCEDURE

open flap debridement

curcumin simvastatin paste

Intervention Type: DRUG

Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.

EDTA root conditioning

Intervention Type: DRUG

EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid

Interventions

currettage

open flap debridement

Intervention Type: PROCEDURE

curcumin simvastatin paste

Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.

Intervention Type: DRUG

EDTA root conditioning

EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid

Intervention Type: DRUG

Other Intervention Names

surgical treatment of periodontal defects; open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).; open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Eman Farouk Mohamed Hussein Elsobky

demonstrator of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Y Gamal, Professor

Role: STUDY_DIRECTOR

Faculty of dentistry- Ain shams university

Other Identifiers

FER16 21-M

Identifier Type: -

Identifier Source: org_study_id