Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
currettage
curcumin simvastatin paste
EDTA root conditioning
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, curcumin, simvastatin, EDTA
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
open flap debridement only
curcumin and simvastatin
EDTA, curcumin and simvastatin
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04044417
Brief Title
Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 25, 2016 (Actual)
Primary Completion Date
May 5, 2018 (Actual)
Study Completion Date
October 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
periodontitis, curcumin, simvastatin, EDTA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open flap debridement only
Arm Type
Placebo Comparator
Arm Description
surgical treatment of periodontal defects
Arm Title
curcumin and simvastatin
Arm Type
Active Comparator
Arm Description
open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
Arm Title
EDTA, curcumin and simvastatin
Arm Type
Active Comparator
Arm Description
open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
Intervention Type
Procedure
Intervention Name(s)
currettage
Other Intervention Name(s)
surgical treatment of periodontal defects
Intervention Description
open flap debridement
Intervention Type
Drug
Intervention Name(s)
curcumin simvastatin paste
Other Intervention Name(s)
open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
Intervention Description
Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.
Intervention Type
Drug
Intervention Name(s)
EDTA root conditioning
Other Intervention Name(s)
open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
Intervention Description
EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid
Primary Outcome Measure Information:
Title
clinical score
Description
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.
Time Frame
change from base line to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Y Gamal, Professor
Organizational Affiliation
Faculty of dentistry- Ain shams university
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis
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