Farrell 2003.
| Methods |
Study design: RCT Location: UK Setting: Guy's and St Thomas Hospitals, UK Recruitment period: unclear |
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| Participants |
Inclusion criteria: 12 weeks gestation, severe periodontal disease (6 or more sites with 5 mm or more probing depth and 3 or more sites with 3 mm or more loss of periodontal attachment) Exclusion criteria: not stated Age: not stated Gestational age: 12 weeks History of preterm delivery: not stated Number randomised: n = 198 Number evaluated: n = 140 (attrition n = 58 lost to follow‐up) |
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| Interventions |
1) Antenatal periodontal treatment (n = 102): 5 visits (baseline assessment, oral hygiene instruction, scaling, hand and ultrasonic instrumentation, follow‐up at 30 weeks and maintenance every month until birth) 2) Control (n = 96): could choose to attend own dentist after birth No information on the expertise of the dental professional who administered intervention |
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| Outcomes | Gestational age; birth weight; miscarriage/stillbirth | |
| Funding | Unclear as full study was not available | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "random allocation table" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Administrative staff allocated subjects via a random allocation table to one of the two groups, following stratification for age, ethnicity, and smoking status" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible |
| Blinding of obstetric outcome assessment (detection bias) | Low risk | Assessor was blinded to group allocation. The outcome in question was assumed to be the obstetric since the study did not report any periodontal outcome |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 40% (41/102) of the treatment group did not receive any periodontal treatment and 57% (58/102) did not attend the follow‐up visit ‐ high attrition rate |
| Selective reporting (reporting bias) | High risk | Periodontal health outcomes were not reported |
| Other bias | Unclear risk | Imbalance in numbers in the 2 groups (102 in the treatment in pregnancy group and 96 in the control group) ‐ about 6% difference |