Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis
Keywords
Abstract
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.
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 03/14/2018 |
| Estimated Enrollment Submitted: | 03/21/2018 |
| First Posted: | 03/22/2018 |
| Last Update Submitted: | 03/15/2020 |
| Last Update Posted: | 03/17/2020 |
| Actual Study Start Date: | 12/31/2014 |
| Estimated Primary Completion Date: | 08/31/2015 |
| Estimated Study Completion Date: | 10/31/2015 |
Condition or disease
Intervention/treatment
Other: Group 1 (Chlorhexidine gel)
Other: Group 2 (Morus alba gel)
Other: Group 3 (Placebo)
Phase
Arm Groups
| 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: Group 1 (Chlorhexidine gel) 0.1 ml of Chlorhexidine gel was administered into the periodontal pocket followed by Coe- pack application. |
| 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: Group 2 (Morus alba gel) 0.1 ml of Morus alba gel was administered into the periodontal pocket followed by Coe- pack application. |
| Placebo Comparator: Group 3 (Placebo) Non surgical periodontal treatment at baseline and no gel is applied. | Other: Group 3 (Placebo) No gel is applied |
Eligibility Criteria
| Ages Eligible for Study | 35 Years To 35 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Reduction in the periodontal pocket depth [45 days]
Secondary Outcome Measures
1. Reduction in the Microbial count of periodontal pathogens [45 days]
2. Reduction in Plaque deposition [45 days]
3. Reduction in gingival inflammation [45 days]
