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Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis

NCT ID: NCT01956656

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-12-31

Brief Summary

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Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective chemical adjunctive measures will likely significantly contribute to overall oral health, the function of which should be to augment mechanical plaque control. Traditionally, in Chinese medicine the lotus leaf has been used for treating gingival inflammation. An extract of lotus leaves have demonstrated significant antibacterial activity against some of the periodontopathogens.

Detailed Description

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The objective of the present research is to evaluate the efficacy of a lotus leaf mouth wash in management of plaque induced gingivitis.

Study design: 30 systemically healthy volunteers will be randomly allocated into two arms

Arm A: Lotus leaf mouth wash (aqueous) group \[Test group\] Arm B: Placebo mouth wash group \[Control group\]

All the volunteers are instructed to refrain from tooth brushing 24 hours before the examination. Clinical parameters (plaque index, bleeding index and gingival index)will be measured and the plaque samples are collected from subjects from each group for microbiological analysis. All the participants will undergo scaling, and they were instructed to refrain from tooth cleaning procedures and were advised to use the prescribed mouth wash twice daily for 4 days. All volunteers were recalled on 5th day for clinical and microbiological analysis. Statistical analysis and results are awaited

Conditions

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Gingivitis

Keywords

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lotus leaf, mouthwash, gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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lotus leaf mouthwash

10 ml mouthwash to be used for 4days twice daily

Group Type PLACEBO_COMPARATOR

lotus leaf mouthwash

Intervention Type DRUG

Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash

placebo mouthwash

10 ml mouthwash to be used for 4 days twice daily

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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lotus leaf mouthwash

Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash

Intervention Type DRUG

Other Intervention Names

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Lotus mouthwash

Eligibility Criteria

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Inclusion Criteria

1. Subjects willing to comply with the study protocol \& instruction.
2. Clinically diagnosed with chronic gingivitis.
3. No history of allergies to herbal formulations.
4. No history of periodontal therapy within the previous 6 months.
5. No history of antibiotic therapy within the previous 6 months.

Exclusion Criteria

1. Any systemic diseases
2. Use of tobacco or tobacco related products
3. Pregnant woman and lactating mothers
4. Subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sri Hasanamba Dental College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Gopi Kishore.C.R.

P.G. student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Ravindra Shivamurthy, MDS

Role: PRINCIPAL_INVESTIGATOR

Sri Hasanamba Dental College and Hospital

Locations

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Sri Hasanamba Dental College and Hospital

Hassan, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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z59p5gy7

Identifier Type: -

Identifier Source: org_study_id