Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Other: Chlorhexidine gel; Other: Morus alba gel; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1 (Chlorhexidine gel); Non surgical periodontal treatment at baseline and 0.1 ml of 1% chlorhexidine gel administered in subsequent visits.	Other: Chlorhexidine gel; 0.1 ml of Chlorhexidine gel was administered into the periodontal pocket
EXPERIMENTAL: Group 2 (Morus alba gel); Non surgical periodontal treatment at baseline and 0.1 ml of 16% Morus alba gel administered in subsequent visits.	Other: Morus alba gel; 0.1 ml of Morus alba gel was administered into the periodontal pocket
PLACEBO_COMPARATOR: Group 3 (Placebo); Non surgical periodontal treatment at baseline and 0.1 ml of placebo gel administered in subsequent visits.	Other: Placebo; 0.1 ml of Placebo gel was administered into the periodontal pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the periodontal pocket depth	Measured by Probing pocket depth	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the Microbial count of periodontal pathogens	Reduction in Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia	45 days
Reduction in Plaque deposition	Measured by Plquel index (Silness and Loe)	45 days
Reduction in gingival inflammation	Measured by Gingival index (Loe and Silness)	45 days

Collaborators and Investigators

• Sponsor: KLE VK Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (ACTUAL): March 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Microbiology; Gel; Chlorhexidine gluconate; Root planing; Morus alba
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: KLEU/Ethic/14-15/D-79

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No