Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Periodontitis

Treatments: Drug: EDTA root conditioning; Procedure: currettage; Drug: curcumin simvastatin paste

Study type: Interventional

Funder types: Other

Identifiers

NCT04044417

FER16 21-M

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

open flap debridement only

Placebo Comparator group

Description:

surgical treatment of periodontal defects

Treatment:

Procedure: currettage

curcumin and simvastatin

Active Comparator group

Description:

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

Treatment:

Drug: curcumin simvastatin paste

Procedure: currettage

EDTA, curcumin and simvastatin

Active Comparator group

Description:

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

Treatment:

Drug: curcumin simvastatin paste

Procedure: currettage

Drug: EDTA root conditioning