Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chlorhexidine gel
Morus alba gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chlorhexidine gluconate, Morus alba, Microbiology, Gel, Root planing
Eligibility Criteria
Inclusion Criteria:
- 35 to 55 years old
- untreated moderate chronic periodontitis having probing pocket depth of ≥5 mm in atleast two different teeth
Exclusion Criteria:
- use of antibiotics or anti-inflammatory drugs during the last 6 months before baseline examination
- Received periodontal treatment in the last 6 months
- pregnant or lactating
- allergy to chlorhexidine or any of the components in the tested products
- using tobacco products in any form
- systemic diseases (e.g., diabetes mellitus, hypertension and immunological disorders)
- ) orthodontic treatment
- alcoholics
- removable prostheses
- Healthy with a normal BMI
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Group 1 (Chlorhexidine gel)
Group 2 (Morus alba gel)
Group 3 (Placebo)
Arm Description
Non surgical periodontal treatment at baseline and 0.1 ml of 1% chlorhexidine gel administered in subsequent visits.
Non surgical periodontal treatment at baseline and 0.1 ml of 16% Morus alba gel administered in subsequent visits.
Non surgical periodontal treatment at baseline and 0.1 ml of placebo gel administered in subsequent visits.
Outcomes
Primary Outcome Measures
Reduction in the periodontal pocket depth
Measured by Probing pocket depth
Secondary Outcome Measures
Reduction in the Microbial count of periodontal pathogens
Reduction in Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia
Reduction in Plaque deposition
Measured by Plquel index (Silness and Loe)
Reduction in gingival inflammation
Measured by Gingival index (Loe and Silness)
Full Information
NCT ID
NCT03475394
First Posted
March 15, 2018
Last Updated
October 17, 2022
Sponsor
KLE VK Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03475394
Brief Title
Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis
Official Title
Comparison of Effectiveness of Morus Alba and Chlorhexidine Gels on Moderate Periodontitis Among 35 to 55 Year Old Subjects: A Hospital Based Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KLE VK Institute of Dental Sciences
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
Background: Periodontitis is a chronic inflammatory disease of tooth and supporting tissues with clinical signs of bone and connective tissue loss and is mediated by a combination of periodontal pathogens and host defense systems. Currently the use of herbal products in dentistry is increasing due to their easy availability, low cost and lesser side effects. One such herbal plant is Morus alba which is known to possess medicinal properties. Therefore the present study was conducted to determine the clinical effectiveness of subgingivally delivered Morus alba gel incorporated into polaxamers vehicle for its controlled release on periodontal pocket in adjunct to scaling and root planing for treatment of moderate periodontitis patients.
Methods: one hundred eighty patients with chronic periodontitis having pocket depth of ≥5 mm in atleast two different teeth were treated by full-mouth scaling and root planning (SRP) and curettage. They were randomly assigned into one of the three groups with 60 in each group: Group 1: Chlorhexidine Sol-gel was applied at baseline, 15 and 30 days. Group 2: Morus alba Sol-gel was applied at baseline, 15 and 30 days. Grpup 3: Placebo gel was applied at baseline, 15 and 30 days. Plaque index (PI) (Silness and Loe), Gingival index (GI) (Loe and Silness), Community Periodontal index, Periodontal pocket depth and quantitative analysis (anaerobic culture) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia were assessed at baseline and after 45 days.
Detailed Description
Morus alba is invaluable member of the plant kingdom belonging to the family Moraceae and the genus Morus. It is extensively cultivated for leaf yield in sericulture. Morus alba have long been used in traditional medicine to improve eyesight, lower blood pressure, prevent diabetes, protect the liver, strengthen joints and treat fever. In particular, few studies on mulberry fruits have reported its biological activities such as antioxidative and anti-inflammatory activities. Even the root bark of has been traditionally used in Asian countries for medicinal purposes due to its anti-inflammatory, hypoglycemic, antibacterial activities. LD50 of extracts of Morus Alba leaves was found to be above 2000 mg/kg which is safe to be used in human beings. Therefore, in the present study the Morus alba leaves has been used in the gel preparation and its effectiveness is assessed against periodontal microorganisms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chlorhexidine gluconate, Morus alba, Microbiology, Gel, Root planing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (Chlorhexidine gel)
Arm Type
Active Comparator
Arm Description
Non surgical periodontal treatment at baseline and 0.1 ml of 1% chlorhexidine gel administered in subsequent visits.
Arm Title
Group 2 (Morus alba gel)
Arm Type
Experimental
Arm Description
Non surgical periodontal treatment at baseline and 0.1 ml of 16% Morus alba gel administered in subsequent visits.
Arm Title
Group 3 (Placebo)
Arm Type
Placebo Comparator
Arm Description
Non surgical periodontal treatment at baseline and 0.1 ml of placebo gel administered in subsequent visits.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine gel
Intervention Description
0.1 ml of Chlorhexidine gel was administered into the periodontal pocket
Intervention Type
Other
Intervention Name(s)
Morus alba gel
Intervention Description
0.1 ml of Morus alba gel was administered into the periodontal pocket
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0.1 ml of Placebo gel was administered into the periodontal pocket
Primary Outcome Measure Information:
Title
Reduction in the periodontal pocket depth
Description
Measured by Probing pocket depth
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Reduction in the Microbial count of periodontal pathogens
Description
Reduction in Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia
Time Frame
45 days
Title
Reduction in Plaque deposition
Description
Measured by Plquel index (Silness and Loe)
Time Frame
45 days
Title
Reduction in gingival inflammation
Description
Measured by Gingival index (Loe and Silness)
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
35 to 55 years old
untreated moderate chronic periodontitis having probing pocket depth of ≥5 mm in atleast two different teeth
Exclusion Criteria:
use of antibiotics or anti-inflammatory drugs during the last 6 months before baseline examination
Received periodontal treatment in the last 6 months
pregnant or lactating
allergy to chlorhexidine or any of the components in the tested products
using tobacco products in any form
systemic diseases (e.g., diabetes mellitus, hypertension and immunological disorders)
) orthodontic treatment
alcoholics
removable prostheses
Healthy with a normal BMI
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis
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