Oliveira 2011.
| Methods |
Study design: RCT Location: Brazil Setting: prenatal care programmes at 2 public hospitals in Belo Horizonte, Brazil Recruitment period: not stated |
|
| Participants |
Inclusion criteria: healthy pregnant women from low socioeconomic status aged 18‐35 years, between 12‐20 weeks gestational age, current single gestation, ≥ 20 natural teeth and the presence of periodontitis Exclusion criteria: current genitourinary infection, chronic hypertension, diabetes, human immunodeficiency virus infection and/or acquired immunodeficiency syndrome, current use of tobacco (smoking), alcohol and/or illicit drug use, and any medical condition requiring antibiotic prophylaxis for dental treatment, use of any antibiotic or nonsteroidal ant‐inflammatory agents, antiseptic mouthwashes and drugs able to induce gingival overgrowth, women undergoing current periodontal treatment Mean age (± standard deviation (years)): Group A = 29.96 ± 4.38, Group B = 26.58 ± 3.96 (P = 0.5) History of preterm delivery: not stated Gestational age: 12 to 20 weeks Periodontitis was defined as: presence of 4 or more teeth with 1 or more sites with probing depth ≥ 4 mm and clinical attachment level as ≥ 3 mm Number randomised: n = 246 Number evaluated: n = 225 (attrition n = 21: spontaneous abortion n = 5, eligible preterm birth n = 8, stillbirth n = 1, abandonment n = 7) |
|
| Interventions |
A) Antenatal periodontal treatment (n = 122): informed of periodontal status and received a kit containing toothbrushes, dental floss and toothpastes, oral hygiene instructions, plaque index evaluations, dental prophylaxis, and mechanical debridement, when necessary, under local anaesthesia on all affected sites each month during the second trimester; final examination 30‐40 days later; periodontal maintenance every 3 weeks until birth. "The personnel who performed the periodontal therapy were trained", however, there was no information on the expertise of the dental professional who administered the intervention B) Postnatal periodontal treatment (n = 124): informed of their periodontal status and received a kit containing toothbrushes, dental floss and toothpastes. Examination at baseline and final periodontal examination between 30 to 32 weeks gestation; postpartum periodontal treatment offered All women: received a complete periodontal examination (probing depth, clinical attachment level, bleeding on probing at 6 sites per tooth) and were informed of their periodontal status |
|
| Outcomes | Preterm birth; low birth weight; probing depth; clinical attachment loss; and bleeding on probing | |
| Funding | Funded by Research Fund of Pontifical Catholic University of Minas Gerais, Brazil | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomly divided" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "randomly divided" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible |
| Blinding of obstetric outcome assessment (detection bias) | Unclear risk | Albeit assessed independently of the caregiver, it is not clear whether obstetric outcome assessment was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 9/122 (7%) women from the intervention group withdrew (2 spontaneous abortion, 3 'eligible preterm birth', 4 abandonment'); 12/124 (10%) women from the control group withdrew (3 spontaneous abortion, 1 stillbirth, 5 eligible preterm birth, 3 'abandonment') Attrition was similarly low and balanced across groups |
| Selective reporting (reporting bias) | Low risk | No apparent reporting bias |
| Other bias | High risk | Intervention group had worse periodontal outcomes at baseline |