Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04044417

Collaborator

(none)

Enrollment

Arms

25.3

Actual Duration (Months)

Study Details

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

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 :

Aug 25, 2016

Actual Primary Completion Date :

May 5, 2018

Actual Study Completion Date :

Oct 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 Names: 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 Names: surgical treatment of periodontal defects Drug: curcumin simvastatin paste Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin. Other Names: 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 Names: surgical treatment of periodontal defects Drug: curcumin simvastatin paste Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin. Other Names: 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 Names: open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

Arm

Intervention/Treatment

Placebo Comparator: open flap debridement only

surgical treatment of periodontal defects

Procedure: currettage

open flap debridement

Other Names:

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 Names:

surgical treatment of periodontal defects

Drug: curcumin simvastatin paste

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

Other Names:

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 Names:

surgical treatment of periodontal defects

Drug: curcumin simvastatin paste

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

Other Names:

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 Names:

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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