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The effect of a behavioural management tool in adults with mild to moderate gum disease

The effect of a behavioural management tool in adults with mild to moderate periodontitis. a single-blind, parallel group, randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29412903
Enrollment
60
Registered
2020-01-30
Start date
2009-10-01
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Periodontal disease Oral Health Periodontal disease

Interventions

The aim is to compare the effect of a behavioral management program (Sonicare Connect) to a standard oral healthcare communication approach (without use of an adjunctive tool) to reduce plaque in subj

Sponsors

Philips Oral Healthcare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 35 - 65 years old 2. Minimum of 20 natural teeth; 35% of all sites with plaque 3. Minimum of 8 sites in at least 2 different quadrants with = 5 mm pocket probing depth (PPD), with 1 – 4mm clinical attachment loss and showing bleeding on probing (BOP) (slight to moderate periodontitis)

Exclusion criteria

Exclusion criteria: 1. Use of antibiotics or anti-inflammatory agents within the previous 2 weeks 2. Need for antibiotic treatment for dental appointments 3. Type I and II uncontrolled diabetes mellitus 4. Pregnant or lactating women 5. Infectious disease including HIV/AIDS 6. Aggressive periodontitis 7. Prior periodontal therapy except for routine dental prophylaxis 8. Current, regular power (electric or battery) toothbrush users

Design outcomes

Primary

MeasureTime frame
Oral health measured using plaque index 14 weeks after baseline (6 weeks after non-surgical therapy completion)

Secondary

MeasureTime frame
1. Clinical efficacy of interventions measured using gingival index (GI), plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP) at 4 weeks and 8 weeks after baseline 2. Clinical efficacy of interventions communication approach in terms of GI, PPD, CAL and BOP at 14 weeks after baseline 3. Attendance, length of visits and percentage proportional talk time measured using patient records of all visits 4. Subjects’ oral healthcare judgement and behavioural parameters documented daily by subjects in brushing diaries from Day -28 through Week 14 post-baseline 5. Subject visit experiences were measured via questionnaires (1-to-5 Disagree-Agree Likert Scale) completed by subjects at Week 1, Week 2, Week 8 and Week 14 6. Questionnaires on practitioner visit experiences (1-to-5 Disagree-Agree Likert Scale) were completed by subjects at Week 1, Week 2, Week 8 and Week 14

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026