Singh 2008.
| Methods |
Trial design: 3‐arm, single‐centre, parallel‐design RCT Location: India Setting: Hospital Number of centres: 1, Department of Periodontics, JSS Dental College, Mysore, India Recruitment period: Not reported Funding source: Quote: "Source of support: Nil" |
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| Participants |
Inclusion criteria: ≥30 years old, either sex; T2 DM; moderate to advanced periodontitis (30% or > of examined teeth with ≥4 mm probing depth); absence of any major diabetic complications; no evidence of any systemic disease (other than diabetes) being a risk factor for periodontitis Exclusion criteria: Uncontrolled DM; periodontal treatment in prior 6 months; antibiotic administration in prior 3 months; <16 remaining natural teeth Age at baseline: Not reported Sex (M:F): Not reported Tobacco use: Not reported Alcohol consumption: Not reported Diabetes type: Type 2 DM Duration since diabetes diagnosis: Not reported Metabolic control: Fair mean HbA1c at baseline Mean HbA1c at baseline: Gp A: mean 7.9% (SD 0.7); Gp B mean 8.3% (SD 0.7); Gp C mean 8.08% (SD 0.7) Antidiabetic therapy: Not specifically reported. All in receipt of antidiabetic therapy but no indication what form ("Exclusion criteria: Patients with uncontrolled DM") Other clinical investigations: FPG, PPBG Number randomised: 45 Number evaluated: 45 |
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| Interventions |
Comparison: SRP + OHI versus SRP + OHI + doxycycline versus no treatment Gp A (n = 15): Full mouth SRP (under local anaesthesia) + OHI Gp B (n = 15): Full mouth SRP + OHI + systemic doxycycline (200 mg on treatment day, followed by 100 mg p/d x 14 days) Gp C (n = 15): No treatment Note: Additionally "after oral examination the teeth with poor prognosis were extracted." No indication which Gps or how many patients received extractions, or whether this may have affected treatment outcomes Duration of follow‐up: 3 months |
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| Outcomes |
Primary: HbA1c (at baseline and 3 months) Secondary: PI, GI, PPD, CAL (at baseline and 3 months) |
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| Notes |
Sample size calculation: Not reported Data analysis: Assumed ITT SES: Not reported Adverse events: Quote: "None of the patients in our study experienced any adverse side effects with doxycycline" HbA1c assessment method: Liquid chromatography Conflict of interests: Authors declare no conflict of interests exists |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "They were randomly divided into three groups of 15 patients each" Comment: No further details |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants | High risk | Not possible, and no placebos used |
| Blinding of clinical operator | High risk | Not reported, and unlikely to be possible due to differing treatments provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No patients reported as lost to follow‐up. Analysis assumed to have been ITT, but not specifically reported |
| Selective reporting (reporting bias) | Unclear risk | Planned outcomes reported for 3 months; however, assessed at 1 month and not reported. Furthermore, no adverse events reported other than for doxycycline use (Gp B) relating to SRP (Gps A+B) or no treatment (Gp C) |
| Other bias | Unclear risk | No patient characteristics presented therefore unknown if baseline imbalances between groups. Also no indication of how many patients in each arm received tooth extractions as part of treatment protocol as wound healing may potentially affect results |