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Completed

NCT Number: NCT03475394

Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gel

Other

0.1 ml of Chlorhexidine gel was administered into the periodontal pocket

Morus alba gel

Other

0.1 ml of Morus alba gel was administered into the periodontal pocket

Placebo

Other

0.1 ml of Placebo gel was administered into the periodontal pocket

Primary outcomes

  1. Reduction in the periodontal pocket depth

    Time frame: 45 days

    Measured by Probing pocket depth

Secondary outcomes

  1. Reduction in the Microbial count of periodontal pathogens

    Time frame: 45 days

    Reduction in Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia

  2. Reduction in Plaque deposition

    Time frame: 45 days

    Measured by Plquel index (Silness and Loe)

  3. Reduction in gingival inflammation

    Time frame: 45 days

    Measured by Gingival index (Loe and Silness)

Sponsors and collaborators

Lead sponsor

KLE VK Institute of Dental Sciences

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2018
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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