Clinical and Anti-inflammatory Effect of Curcumin Oral Gel as Adjuncts in Treatment of Periodontal Pocket
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Early Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
curcumin Oral gel
subgingival scaling and root planing
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Age group of 30-45 years.
- Belonging to both sexes.
- Chronic periodontitis patients.
- Probing pocket depth (PPD) 5-7 mm.
Exclusion Criteria:
- Subjects having taken antibiotics prior to or during the trial.
- Patients on medication likely to induce gingival enlargement.
- Pregnant or lactating women.
- Smokers.
- Tobacco chewers.
- Allergy to curcumin oral gel.
- Patients with systemic disease.
Sites / Locations
- university of Baghdad college of dentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
curcumin oral gel
subgingival scaling and root planing
Arm Description
Outcomes
Primary Outcome Measures
measuring interleukin -8
measuring interleukin -8 in gingival crevicular fluid by using ELISA
measuring plaque accumulation
measuring plaque accumulation on the teeth by measuring the plaque index using periodontal probe
measuring gingival inflammation
measuring gingival inflammation by measuring the gingival index by using periodontal probe
measuring periodontal pocket erosion
measuring periodontal pocket erosion and destruction by measuring bleeding on probing index using periodontal probe
measuring the periodontal pocket depth
measuring the periodontal pocket depth by using periodontal pocket depth index using periodontal probe
measuring periodontal attachment level
measuring periodontal attachment level by measuring clinical attachment level index using periodontal probe
Secondary Outcome Measures
Full Information
NCT ID
NCT04355416
First Posted
April 15, 2020
Last Updated
April 20, 2020
Sponsor
University of Baghdad
Collaborators
Najaf dental specialized center
1. Study Identification
Unique Protocol Identification Number
NCT04355416
Brief Title
Clinical and Anti-inflammatory Effect of Curcumin Oral Gel as Adjuncts in Treatment of Periodontal Pocket
Official Title
Clinical Evaluation of 1% Curcumin Oral Gel and Its Effect on the Clinical Attachment Level and the Level of IL-8 in GCF in Treatment of Periodontal Pocket
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
Collaborators
Najaf dental specialized center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
application of 1% curcumin gel in clinical study design will be used . The study will be conducted in Al-Najaf specialised dentistry center. The group of patients will be consist of 25 patients, belonging to both sex, age between 30-45 years. All patients will be diagnosed as chronic periodontitis with periodontal pockets of depth 5-7mm bilaterally to be randomly selected.
Detailed Description
Abstract:
Background: Complete removal of irritants is not possible with mechanical therapy alone. Adjunctive use of systemic administration of antibiotics results in the distribution of drug throughout the body, which can give rise to toxicity. Curcumin (diferuloylmethane), a constituent of Curcuma longa plant, which possess antioxidant, anti-inflammatory, and anti-microbial properties. The aim of the study is to determine the effect of curcumin oral gel on the anti-inflammatory chemokines (IL_8) in the gingival crevicular fluid and to compare the effects of the curcumin gel as an adjunct to sub gingival scaling and root planing with the effect achieved using sub gingival scaling and root planing alone.
Twenty systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed and the patients will receive a complete prophylaxis including scaling and root planning. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planning alone will be performed followed by periodontal pack application. collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
The aim of the study :
To determine the effect of curcumin oral gel on the anti inflammatory chemokines (IL_8) in the gingival crevicular fluid and to compare the effects of the curcumin gel as an adjunct to sub gingival scaling and root planning with the effect achieved using sub gingival scaling and root planing alone in the treatment of (5-7 mm) periodontal pockets on clinical Parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level).
Objectives:
To evaluate the efficacy of sub gingival application of curcumin gel as an adjunct to SRP in the treatment of (5-7 mm) periodontal pockets on clinical periodontal parameter.
To measure the concentration of IL-8 in gingival crevicular fluid before and after treatment.
Hypothesis:
Curcumin gel may have anti-inflammatory effect by reducing IL-8 and may have effect on clinical Parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level) in the treatment of periodontal pockets .
Alternative hypothesis:
There may be no difference in treatment of periodontal pocket by scaling and root planning and by scaling and root planning adjunct by curcumin oral gel.
Methodology:
Study design: Double blind, prospective , bio clinical research.
Setting: AL-Najaf dental specialized center.
Study design and population:
Twenty systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed and the patients will receive a complete prophylaxis including scaling and root planing. Selected sites will be randomized into control and experimental sites. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planing alone will be performed followed by periodontal pack application. collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
Procedure/intervention:
collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measuring of the clinical parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level) prior to the each procedure. The pocket will randomly have selected for both groups. PD will be measured with UNC 15 mm probe, acrylic stent as a guide for reproducibility from the gingival margin to base of the pocket. To achieve concealment, the patient will be blinded about intervention which side is test and which side is control. Before baseline (baseline regarded as first visit) we do oral hygiene motivation and supra gingival scaling only. At first visit (baseline ) day 0 will include collecting GCF from pocket of both side ( test and control ) to determine the level of IL_8 by ELISA and measurement of the clinical parameters : PLI (plaque index) , BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level) it also include sub gingival scaling and root planing for both side and curcumin gel will be inserted to the pocket of tested group with a 2 ml disposable syringe equipped with a blunted 25-gauge needle, which is bent along its shank after that periodontal dressing (Coe- Pak) will be used to cover the pocket on both side so as to prevent the ingress of oral fluids as well as to allow the retention of the material within the pocket. The first visit will also include oral hygiene instructions. Subjects will be recalled after 7 days, for periodontal dressing to be removed and curcumin gel will be inserted to the pocket of tested group.
The second visit (after thirty day)will include collecting GCF from the same previous site of pocket on both side to determine the level of IL_8 by ELISA and measurement of the clinical parameters : PLI (plaque index) , BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level).To ensure excellent collection of GCF, we must make sure the sites should be dried and not contaminated by saliva or blood, using cotton rolls, gentle force should be applied to avoid bleeding and the periocol strip should be inserted for 30 seconds, the sample will be transferred into eppendrof tubes and stored in -20 c until the completion of the samples collections, the tube will be allocated to the patient'code.
Assessment of the clinical parameters in the recall visit, separation of the GCF will be done by the following procedure : each sample will be micro centerfuged at 400-500g for 4-5 min then diluted by 500 microliter phosphate buffered saline and stored overnight in 4c to achieve optimal protein elusion. the periocol is then removed and the supernatants will be assayed by ELISA.
The total level of the IL_8 will be determined by using ELISA kits according to the manufacture instruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Twenty five systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed Selected sites will be randomized into control and experimental sites. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planing alone will be performed followed by periodontal pack application. collecting of GCF from the pocket to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
Masking
Care Provider
Masking Description
care provider not involved in the study
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
curcumin oral gel
Arm Type
Experimental
Arm Title
subgingival scaling and root planing
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
curcumin Oral gel
Intervention Description
application of curcumin oral gel after scaling and root planing
Intervention Type
Procedure
Intervention Name(s)
subgingival scaling and root planing
Intervention Description
subgingival scaling and root planing without application of curcumin gel
Primary Outcome Measure Information:
Title
measuring interleukin -8
Description
measuring interleukin -8 in gingival crevicular fluid by using ELISA
Time Frame
one month
Title
measuring plaque accumulation
Description
measuring plaque accumulation on the teeth by measuring the plaque index using periodontal probe
Time Frame
one month
Title
measuring gingival inflammation
Description
measuring gingival inflammation by measuring the gingival index by using periodontal probe
Time Frame
one month
Title
measuring periodontal pocket erosion
Description
measuring periodontal pocket erosion and destruction by measuring bleeding on probing index using periodontal probe
Time Frame
one month
Title
measuring the periodontal pocket depth
Description
measuring the periodontal pocket depth by using periodontal pocket depth index using periodontal probe
Time Frame
one month
Title
measuring periodontal attachment level
Description
measuring periodontal attachment level by measuring clinical attachment level index using periodontal probe
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age group of 30-45 years.
Belonging to both sexes.
Chronic periodontitis patients.
Probing pocket depth (PPD) 5-7 mm.
Exclusion Criteria:
Subjects having taken antibiotics prior to or during the trial.
Patients on medication likely to induce gingival enlargement.
Pregnant or lactating women.
Smokers.
Tobacco chewers.
Allergy to curcumin oral gel.
Patients with systemic disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haider Th Farhood, B.D.S
Phone
+9647811967728
Email
haideralhisnawi19.12.88@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Basima Gh Ali, MSc
Phone
+9647705027397
Email
Dr.basimaali@gmail.com
Facility Information:
Facility Name
university of Baghdad college of dentistry
City
Baghdad
ZIP/Postal Code
+964
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haider Th Farhood, B.D.S
Phone
+9647811967728
Email
haideralhisnawi19.12.88@gmail.com
First Name & Middle Initial & Last Name & Degree
Basima Gh Ali, MSc
Phone
+9647705027397
Email
Dr.basimaali@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical and Anti-inflammatory Effect of Curcumin Oral Gel as Adjuncts in Treatment of Periodontal Pocket
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