Chronic PeriodontitisNCT03475394
Effectiveness of Locally Delivered Morus Alba Gel on Moderate Periodontitis
A study testing Chlorhexidine gel and Morus alba gel in people with Chronic Periodontitis, run by KLE VK Institute of Dental Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Chlorhexidine gel and Morus alba gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 35 to 55 years old
- untreated moderate chronic periodontitis having probing pocket depth of ≥5 mm in atleast two different teeth
Who cannot join
- 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)
Show all 10Show fewer
- ) orthodontic treatment
- alcoholics
- removable prostheses
- Healthy with a normal BMI
About this study
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
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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- Chlorhexidine gel, Morus alba gel, Placebo
- Keywords
- Chlorhexidine gluconate, Morus alba, Microbiology, Gel, Root planing
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gelOther
0.1 ml of Chlorhexidine gel was administered into the periodontal pocket
Morus alba gelOther
0.1 ml of Morus alba gel was administered into the periodontal pocket
PlaceboOther
0.1 ml of Placebo gel was administered into the periodontal pocket
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Chlorhexidine gel) | Active comparator | Non surgical periodontal treatment at baseline and 0.1 ml of 1% chlorhexidine gel administered in subsequent visits. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the periodontal pocket depth
Measured by Probing pocket depth
Measured: 45 days
Secondary outcomes (3)
Reduction in the Microbial count of periodontal pathogens
Reduction in Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia
Measured: 45 days
Reduction in Plaque deposition
Measured by Plquel index (Silness and Loe)
Measured: 45 days
Reduction in gingival inflammation
Measured by Gingival index (Loe and Silness)
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startJan 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- KLE VK Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shilpa Gunjal, KLE VK Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475394
- Sponsor's protocol ID
- KLEU/Ethic/14-15/D-79
- Status last verified
- Oct 2022
- First submitted
- 15 Mar 2018
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03475394
- Acronym / sponsor ID
- KLEU/Ethic/14-15/D-79
- Conditions
- Chronic Periodontitis
- Keywords
- Chlorhexidine gluconate, Morus alba, Microbiology, Gel, Root planing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- KLE VK Institute of Dental SciencesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Chlorhexidine gel) | Active comparator | Other: Chlorhexidine gelNon surgical periodontal treatment at baseline and 0.1 ml of 1% chlorhexidine gel administered in subsequent visits. |
| Group 2 (Morus alba gel) | Experimental | Other: Morus alba gelNon surgical periodontal treatment at baseline and 0.1 ml of 16% Morus alba gel administered in subsequent visits. |
| Group 3 (Placebo) | Placebo comparator | Other: PlaceboNon surgical periodontal treatment at baseline and 0.1 ml of placebo gel administered in subsequent visits. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 35 to 55 years old
- untreated moderate chronic periodontitis having probing pocket depth of ≥5 mm in atleast two different teeth
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gel0.1 ml of Chlorhexidine gel was administered into the periodontal pocket | Other | Group 1 (Chlorhexidine gel) |
| Morus alba gel0.1 ml of Morus alba gel was administered into the periodontal pocket | Other | Group 2 (Morus alba gel) |
| Placebo0.1 ml of Placebo gel was administered into the periodontal pocket | Other | Group 3 (Placebo) |
Primary outcome
Reduction in the periodontal pocket depth
Time frame: 45 days
Measured by Probing pocket depth
3 secondary outcomes
Reduction in the Microbial count of periodontal pathogens
Time frame: 45 days
Reduction in Plaque deposition
Time frame: 45 days
Reduction in gingival inflammation
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine gel and Morus alba gel in people with Chronic Periodontitis, run by KLE VK Institute of Dental Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the periodontal pocket depth (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.