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Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis

S

Sri Hasanamba Dental College and Hospital

Status

Unknown

Conditions

Gingivitis

Treatments

Drug: lotus leaf mouthwash

Study type

Interventional

Funder types

Other

Identifiers

NCT01956656
z59p5gy7

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

lotus leaf mouthwash
Placebo Comparator group
Description:
10 ml mouthwash to be used for 4days twice daily
Treatment:
Drug: lotus leaf mouthwash
placebo mouthwash
Placebo Comparator group
Description:
10 ml mouthwash to be used for 4 days twice daily

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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