A clinical trial to study the effects of herbal mouthwash among visually impaired for plaque control and reducing gingivitis.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/03/008049
• Date of registration: 08-03-2017
• Prospective Registration: Yes
• Primary sponsor: Dr Sirjana Dahal
• Public title: A clinical trial to study the effects of herbal mouthwash among visually impaired for plaque control and reducing gingivitis.
• Scientific title: EFFECTIVENESS OF HERBAL MOUTHWASH AMONG STUDENTS AT A RESIDENTIAL SCHOOL FOR VISUALLY IMPAIRED IN DHARAN, NEPAL: A RANDOMIZED-CONTROLLED TRIAL
• Date of first enrolment: 12-03-2017
• Target sample size: 60
• Recruitment status: Not Applicable
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17773
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3/ Phase 4

Countries of recruitment

Nepal

Contacts

• Name: Ashish Shrestha
• Affiliation: B.P. Koirala Institute of health sciences

• Name: Ashish Shrestha
• Affiliation: B.P. Koirala Institute of health sciences

Key inclusion & exclusion criteria

Inclusion criteria: 1. Visually impaired children with minimum of 20 teeth present

2. Patient diagnosed with mild to moderate type of gingivitis

3. Patient with bleeding on probing present, clinically

4. Patient who had not received any periodontal therapy except oral prophylaxis for the past 6 months

5. Patient willing to give the informed consent and willing to comply with the study




Exclusion criteria: 1. Subjects taking antibiotics or any other drugs within last three months

2. Medically compromised children

3. Smokers

4. Patients who has periodontal pockets in excess of 4 mm/clinical attachment loss.

5. Partial dentures or clinically unacceptable restorations or bridges.

6. Patient with orthodontic appliances/undergoing orthodontic treatment

7. Patient with a known history of allergy to chemical or any herbal products



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Herbal mouthwash
(Hiora mouthwash regular, manufactured by the Himalaya Drug Company Makali, Bangalore, India): -Herbal mouthwash (15ml) to swiss for 30 seconds and spit
-Route of administration: rinse, half and hour after tooth brushing
-frequency: twice daily
-Duration: 2 weeks (14 days)

Control Intervention1: placebo mouthwash (Coloured distilled water solution):
Placebo mouthwash (20ml) to swiss for 30 seconds and spit
-Route of administration: rinse, half and hour after tooth brushing
-frequency: twice daily
-Duration: 2 weeks (14 days)
Control Intervention2: chlorhexidine mouthwash
(Hexidine manufactured by ICPA health products LTD): chlorhexidine mouthwash (20ml, 1:1 dilution) to swiss for 30 seconds and spit -Route of administration: rinse, half and hour after tooth brushing -frequency: twice daily -Duration: 2 weeks (14 days)

Primary Outcome(s)

The primary outcomes measured were reduction in visible plaque and severity of gingivitis by changing from the baseline plaque and gingival scores after the use of herbal mouthwash. Baseline plaque and gingival scores were compared to the scores after the use of herbal mouthwash.

Timepoint: 2 weeks

Secondary Outcome(s)

The secondary outcome comparison of reduction in visible plaque and gingivitis among three mouthwashes.

Timepoint: 2 weeks

Secondary ID(s)

NIL

Source(s) of Monetary Support

by self

Ethics review

Status: Approved
Approval date: 04/12/2016
Contact:

Institutional Review Committee, BPKIHS, Dharan, Nepal