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Curcumin Paste as an Adjunctive Therapy in Periodontitis

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

Study Description
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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)

Condition or disease Intervention/treatment Phase
Periodontitis Drug: curcumin paste Procedure: curettage Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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"
Actual Study Start Date : August 20, 2016
Actual Primary Completion Date : May 6, 2018
Actual Study Completion Date : November 5, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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Arm Intervention/treatment
Experimental: curcumin paste in conjunction with open flap debridement surge
curcumin paste (2% circumin) in conjunction with open flap debridement surgery
 Drug: curcumin paste
curcumin is a herb used for medical purpose

Procedure: curettage
open flab debridement surgery
Placebo Comparator: open flap debridement surgery only
surgical treatment for periodontal pocket
 Procedure: curettage
open flab debridement surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032132


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Ahmed Y Gamal, professor Faculty of dentistry -Ain Shams university
More Information
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Responsible Party: Yasmine Gamal, Administrator of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04032132    
Other Study ID Numbers: FER16 20-M
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Yasmine Gamal, Ain Shams University:
curcumin
CBCT
HPLC
periodontitis
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action