A Clinical Trial to compare Regular Toothbrushing With and Without a Portable Electric Oral Irrigator in Reducing Bleeding Gums Among Adults with Gum Inflammation

Efficacy Of Portable Electric Oral Irrigator as an adjunct to manual Tooth brushing in Adults with Gingivitis-A Randomized Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105565

Enrollment

Registered

2026-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K050- Acute gingivitis

Interventions

Intervention1: Portable electric Oral Irrigator: Treatment using Manual Tooth brushing along with Oral Irrigators as adjunct. Control Intervention1: Tooth Brushing: Treatment using Manual Tooth brush

Eligibility

Inclusion criteria

Inclusion criteria: Untreated patients diagnosed with Dental Biofilm Induced Gingivitis on intact periodontium according to the 2017 Periodontal Classification Adults aged 18 years and above regardless of gender. Individuals in overall good systemic health who practice daily tooth brushing Possessing a minimum of 20 permanent teeth (excluding third molars) with at least five assessable teeth in each quadrant. Patients willing to comply with the study protocols and follow-up visits.

Exclusion criteria

Exclusion criteria: Pregnant or lactating Tobacco smokers Regular users of electric toothbrushes, dental floss, interdental brushes,mouthrinses or other oral hygiene adjuncts Those wearing orthodontic appliance, removable dentures or large prosthesis. Individuals who have undergone Professional scaling within the past 6 weeks. Patients with untreated dental caries,mucosal lesions,xerostomia,oral tumours and systemic disease that may influence Periodontal health.

Design outcomes

Primary

Measure	Time frame
To find out if there is any difference in Bleeding Index estimated by Modified Sulcus Index by Mombelli following the use of Portable Electric Oral Irrigator as an adjunct to manual Tooth brushing in Dental Biofilm Induced Gingivitis patients with intact periodontium with baseline 4weeks, 8weeks using UNC-15 probe. Timepoint: To find out if there is any difference in Bleeding Index estimated by Modified Sulcus Index by Mombelli following the use of Portable Electric Oral Irrigator as an adjunct to manual Tooth brushing in Dental Biofilm Induced Gingivitis patients with intact periodontium with baseline 4weeks, 8weeks using UNC-15 probe.	—

Measure

Time frame

To find out if there is any difference in Bleeding Index estimated by Modified Sulcus Index by Mombelli following the use of Portable Electric Oral Irrigator as an adjunct to manual Tooth brushing in Dental Biofilm Induced Gingivitis patients with intact periodontium with baseline 4weeks, 8weeks using UNC-15 probe. Timepoint: To find out if there is any difference in Bleeding Index estimated by Modified Sulcus Index by Mombelli following the use of Portable Electric Oral Irrigator as an adjunct to manual Tooth brushing in Dental Biofilm Induced Gingivitis patients with intact periodontium with baseline 4weeks, 8weeks using UNC-15 probe.

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Secondary

Measure	Time frame
To find out if there is any difference in the following parameters with the baseline, 4weeks and 8weeks Modified Gingival Index by Lobene Bleeding on Probing Percentage (BOP%) using UNC-15 probe Plaque Index using Silness and Loe index To assess pain and Dentin hypersensitivity by Numerical Pain Rating Scale Compliance of patient using manual or electronic dairy Timepoint: baseline 4 weeks 8 weeks	—

Measure

Time frame

To find out if there is any difference in the following parameters with the baseline, 4weeks and 8weeks Modified Gingival Index by Lobene Bleeding on Probing Percentage (BOP%) using UNC-15 probe Plaque Index using Silness and Loe index To assess pain and Dentin hypersensitivity by Numerical Pain Rating Scale Compliance of patient using manual or electronic dairy Timepoint: baseline 4 weeks 8 weeks

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Countries

India

Contacts

Public ContactDr K C Ajithkumar

Government Dental College Thiruvananthapuram

ajitkesavan73@gmail.com9846068227

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026