Macones 2010.
| Methods |
Study design: RCT Location: USA Setting: Periodontal Infections and Prematurity Study (PIPS), a multicentre trial, was conducted in 3 antenatal clinics in metropolitan Philadelphia, USA Recruitment period: not stated |
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| Participants |
Inclusion criteria: women between 6 and 20 weeks gestation with periodontal disease who returned for the scheduled treatment visit Exclusion criteria: periodontal treatment during pregnancy, antibiotic use within 2 weeks; use of antimicrobial mouthwash within 2 weeks, multiple gestation, and known mitral valve prolapse Mean age (± standard deviation (years)): Group A = 24.1 ± 5.2, Group B = 24.4 ± 5.7 (P = 0.41) Gestational age: 6 to 20 weeks History of preterm delivery (%): Group A = 11.7, Group B = 12.9 (P = 0.62) Periodontal characteristics: periodontal disease was defined as attachment loss ≥ 3 mm on ≥ 3 teeth. Moderate/severe ‐ Group A = 54.8, Group B = 55.3 (P = 0.9) Number randomised: n = 756 Number evaluated: n = 713 (attrition n = 43; lost to follow‐up n = 43) |
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| Interventions |
A) Antenatal periodontal treatment ‐ Scaling and root planing (n = 376) B) Antenatal periodontal treatment ‐ Superficial tooth cleaning procedure (n = 380): superficial tooth cleaning procedure involved using the rotating cup to remove stains and plaque from the supragingival portion of the tooth using minimally abrasive polishing past. No sharp instruments were used for the subgingival removal of calculus Interventions were delivered by hygienists |
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| Outcomes | Spontaneous preterm birth (occurring < 35 weeks of gestation because of either idiopathic preterm labour or from preterm premature rupture of the amniotic membranes); < 37 weeks of gestational age, < 35 weeks gestational age; gestational age at delivery; birth weight; neonatal adverse outcomes (respiratory distress syndrome, chronic lung disease, necrotizing enterocolitis, grade III/IV intraventricular haemorrhage (IVH), sepsis, death), stillbirth, miscarriage | |
| Funding | Not stated | |
| Notes | For a prevalence of preterm birth at < 35 weeks of gestation of 7%, it was estimated that 636 participants would be needed per treatment group and the goal was to recruit 700 subjects per treatment group. However, because of temporal restraints that were mandated by the mechanism of funding, enrolment stopped after 3 years of recruitment, which was well before the target sample size was reached | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was accomplished centrally at the University of Pennsylvania, although each clinical site had its own randomisation scheme. A permuted block randomisation procedure was used to formulate assignment lists to assure close to equal numbers of subjects in each treatment group. A uniform block size of 4 was used" |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was accomplished centrally at the University of Pennsylvania..." Comment: this suggests central allocation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Caregivers were unblinded |
| Blinding of obstetric outcome assessment (detection bias) | Low risk | Quote: "Members of the investigative team (including the obstetricians) who assessed our primary and secondary end points were blinded to treatment assignment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates were similarly low and balanced across groups for all outcomes |
| Selective reporting (reporting bias) | High risk | Periodontal health outcomes were not reported |
| Other bias | High risk | There were more participants of high socioeconomic status in the control group. Enrollment stopped after 3 years of recruitment due to restraints mandated by the funding mechanism |