Curcumin Paste as an Adjunctive Therapy in Periodontitis

• ClinicalTrials.gov Identifier: NCT04032132
• Recruitment Status: Completed
• First Posted: July 25, 2019
• Last Update Posted: July 25, 2019
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Yasmine Gamal, Ain Shams University

Tracking Information

• First Submitted Date: July 19, 2019
• First Posted Date: July 25, 2019
• Last Update Posted Date: July 25, 2019
• Actual Study Start Date: August 20, 2016
• Actual Primary Completion Date: May 6, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 23, 2019)

clinical score [ Time Frame: change from base line at 6 months ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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"
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Periodontitis

Intervention

• Drug: curcumin paste
  curcumin is a herb used for medical purpose
• Procedure: curettage
  open flab debridement surgery

Study Arms

• Experimental: curcumin paste in conjunction with open flap debridement surge
  curcumin paste (2% circumin) in conjunction with open flap debridement surgery
  Interventions:

  • Drug: curcumin paste
  • Procedure: curettage
• Placebo Comparator: open flap debridement surgery only
  surgical treatment for periodontal pocket
  Intervention: Procedure: curettage

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 23, 2019): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 5, 2018
• Actual Primary Completion Date: May 6, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Male or female with age range 25-45 years.
2. 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.
3. 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04032132
• Other Study ID Numbers: FER16 20-M
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Yasmine Gamal, Ain Shams University
• Study Sponsor: Ain Shams University
• Collaborators: Not Provided

Investigators

• Study Director: Ahmed Y Gamal, professor; Faculty of dentistry -Ain Shams university

• PRS Account: Ain Shams University
• Verification Date: July 2019