Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

August 4, 2019 updated by: Eman Farouk Mohamed Hussein Elsobky, Ain Shams University

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical score
Time Frame: 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.
change from base line to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2016

Primary Completion (Actual)

May 5, 2018

Study Completion (Actual)

October 3, 2018

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 4, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER16 21-M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on currettage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe