Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis

NCT03475394 | Completed DMC

• 1 other identifier: KLEU/Ethic/14-15/D-79
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Keywords

Chlorhexidine gluconate; Morus alba; Microbiology; Gel; Root planing

Outcome Measures

Primary Outcomes (1)

• Reduction in the periodontal pocket depth

  Measured by Probing pocket depth

  45 days

Secondary Outcomes (3)

• Reduction in the Microbial count of periodontal pathogens

  45 days

• Reduction in Plaque deposition

  45 days

• Reduction in gingival inflammation

  45 days

Study Arms (3)

Group 1 (Chlorhexidine gel)

ACTIVE COMPARATOR

Non surgical periodontal treatment at baseline and 0.1 ml of 1% chlorhexidine gel administered in subsequent visits.

Other: Chlorhexidine gel

Group 2 (Morus alba gel)

EXPERIMENTAL

Non surgical periodontal treatment at baseline and 0.1 ml of 16% Morus alba gel administered in subsequent visits.

Other: Morus alba gel

Group 3 (Placebo)

PLACEBO COMPARATOR

Non surgical periodontal treatment at baseline and 0.1 ml of placebo gel administered in subsequent visits.

Other: Placebo

Interventions

Chlorhexidine gel OTHER

0.1 ml of Chlorhexidine gel was administered into the periodontal pocket

Group 1 (Chlorhexidine gel)

Morus alba gel OTHER

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

Group 2 (Morus alba gel)

Placebo OTHER

0.1 ml of Placebo gel was administered into the periodontal pocket

Group 3 (Placebo)

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KLE VK Institute of Dental Sciences: lead

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 23, 2018
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share