Christou 1998.
Methods | Trial design: split‐mouth, (2 arms) Location: Academic Centre for Dentistry, Amsterdam, The Netherlands Number of centres: 1 Recruitment period: not reported |
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Participants | Inclusion criteria: adult patients not previously treated for periodontitis, 25 years old or older, at least 3 natural teeth present in each quadrant Exclusion criteria: use of antibiotics over last 3 months before baseline, use of interdental cleaning aids on a regular basis Baseline plaque: not reported Baseline periodontal status: generalised moderate to severe periodontitis, the presence of at least 1 site in each quadrant for fulfilling all following criteria: probing depths > 5 mm, bleeding on probing and radiographic evidence of alveolar bone loss, gingiva with little or no recession showing overt signs of inflammation Age at baseline (years): age range 27 to 72, mean age 37.4 Sex: 14 males/12 females Number randomised: 26 (Gp A and Gp B both had 26 participants as this was a split‐mouth study) Number evaluated: 26 (Gp A and Gp B both had 26 participants as this was a split‐mouth study) Attrition per group: none lost to follow‐up Smoking status: not reported |
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Interventions |
Comparison: manual toothbrushing and interdental brushing versus manual toothbrushing and flossing Gp A (n = 26 evaluated) interdental brushes (frequency of use not reported) Gp B (n = 26 evaluated) dental floss (frequency of use not reported) All participants received a manual toothbrush Duration of intervention: 6 weeks Training: participants received detailed instructions for use of a manual toothbrush, dental floss and interdental brushes by a dental hygienist and were provided with by take‐home written instructions. Baseline cleaning: supragingival calculus was removed at sites where interference with interdental cleaning occurred. Compliance assessment: compliance was confirmed by a telephone call after a week of treatment. After 3 weeks, oral hygiene instructions were reinforced by the dental hygienist. |
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Outcomes | Measurements: at baseline and 6 weeks Dental plaque: Volpe modification of Quigley and Hein Plaque Index Periodontal disease ‐ gingivitis: measured by bleeding on probing (BOP) assessed by Angulated Bleeding Index (ABI) and Periodontal Pocket Bleeding Index (PPBI) Probing depth (PD) evaluated using a force controlled probe Adverse effects: self‐reported; participants completed a questionnaire concerning any problems with dental floss (DF) or interdental brushes (IDB), level of comfort in handling the 2 devices and their perception of efficacy of the devices. 14 participants experienced problems with use of dental floss, 2 with use of interdental brushes, 2 with both, and 8 did not encounter any problems. Attrition: no participants were lost from the study. |
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Funding | State Scholarship Foundation of Greece gave a grant; Entra ‐ Lactona BV provided brushes and interdental brushes. | |
Notes | Trial authors recorded interdental spaces that could not be entered by the assigned interdental device and excluded them from the analysis (12 sites for any size of the IDB and 2 sites for the DF). All measurements were carried out by the same examiner under the same conditions; examiner reliability was not reported, but a force‐controlled probe was used allowing confidence in the outcome assessment. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The use of DF was randomly assigned to the left or the right side of the mouth and the use of IDB to the other side" Comment: no further information given |
Allocation concealment (selection bias) | Low risk | Split‐mouth study |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants was not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All procedures concerning instruction, cleaning and exclusion of sites from the analyses were performed in the absence of the examiner, keeping these recordings blind throughout the study" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There were no losses to follow‐up. 12 sites not accessible to any size of IDB and 2 sites not accessible to DF were excluded from the analysis. Total number of assessed sites not reported |
Selective reporting (reporting bias) | Low risk | No protocol available. All outcomes stated in the Methods section were addressed in the Results. |
Other bias | Unclear risk | Compliance confirmed by a telephone call after a week of treatment, but not reported. |