Curcumin Paste as an Adjunctive Therapy in Periodontitis
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
curcumin paste
curettage
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis focused on measuring curcumin, CBCT, HPLC, periodontitis
Eligibility Criteria
Inclusion Criteria:
- Male or female with age range 25-45 years.
- At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann & Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy.
- Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008).
Exclusion Criteria:
- 1- Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
curcumin paste in conjunction with open flap debridement surge
open flap debridement surgery only
Arm Description
curcumin paste (2% circumin) in conjunction with open flap debridement surgery
surgical treatment for periodontal pocket
Outcomes
Primary Outcome Measures
clinical score
Evaluate the influence of curcumin paste on the clinical outcomes of the surgical treatment.to see if curcumin has a positive effect in reduction oh deep periodontal pockets and leads to greater bone gain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04032132
Brief Title
Curcumin Paste as an Adjunctive Therapy in Periodontitis
Official Title
The Local Application of Curcumin in Conjunction With the Surgical Treatment of Intrabony Periodontal Defects "Controlled Clinical Study With Evaluation of Curcumin Release Profile"
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2016 (Actual)
Primary Completion Date
May 6, 2018 (Actual)
Study Completion Date
November 5, 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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The turmeric (Curcuma longa) plant, a herb belonging to the ginger family. The most active component of turmeric is curcumin, which makes up 2 to 5% of the spice. Curcumin showed has antibacterial effect against periodontal pathogen and positive result regarding conventional treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing properties. This study will be carried out to examine the effect of curcumin 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 twenty four patients having stage II or stage III, Grade A periodontitis with 24 intrabony defects. Patients were divided into two groups; group I was subjected to open flap debridement only. Group II was subjected to curcumin paste (2%curcumin)in conjunction with open flap debridement 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 paste.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
curcumin, CBCT, HPLC, periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
curcumin paste in conjunction with open flap debridement surge
Arm Type
Experimental
Arm Description
curcumin paste (2% circumin) in conjunction with open flap debridement surgery
Arm Title
open flap debridement surgery only
Arm Type
Placebo Comparator
Arm Description
surgical treatment for periodontal pocket
Intervention Type
Drug
Intervention Name(s)
curcumin paste
Intervention Description
curcumin is a herb used for medical purpose
Intervention Type
Procedure
Intervention Name(s)
curettage
Intervention Description
open flab debridement surgery
Primary Outcome Measure Information:
Title
clinical score
Description
Evaluate the influence of curcumin paste on the clinical outcomes of the surgical treatment.to see if curcumin has a positive effect in reduction oh deep periodontal pockets and leads to greater bone gain
Time Frame
change from base line at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female with age range 25-45 years.
At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann & Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy.
Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008).
Exclusion Criteria:
1- Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)
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 Paste as an Adjunctive Therapy in Periodontitis
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