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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
KLE VK Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 35 to 55 years old
  2. untreated moderate chronic periodontitis having probing pocket depth of ≥5 mm in atleast two different teeth

Exclusion Criteria:

  1. use of antibiotics or anti-inflammatory drugs during the last 6 months before baseline examination
  2. Received periodontal treatment in the last 6 months
  3. pregnant or lactating
  4. allergy to chlorhexidine or any of the components in the tested products
  5. using tobacco products in any form
  6. systemic diseases (e.g., diabetes mellitus, hypertension and immunological disorders)
  7. ) orthodontic treatment
  8. alcoholics
  9. removable prostheses
  10. 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

    First Posted
    March 15, 2018
    Last Updated
    October 17, 2022
    Sponsor
    KLE VK Institute of Dental Sciences
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    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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