Herrera 2009.
| Methods |
Study design: RCT Location: Colombia Setting: Hospital Universitario del Valle, Cali, Colombia Recruitment period: March 2006 and December 2007 |
|
| Participants |
Periodontal characteristics: 62% of women had chronic periodontitis (American Academy of Periodontology criteria) Inclusion criteria: pregnant women with mild pre‐eclampsia (blood pressure < 160/11 and proteinuria ≥ 300 mg/L in 24 hours urine) with gestational age between 26 and 34 weeks (no restriction on parity or mother's age); women who had not received antibiotics in the previous 3 months, or periodontal treatment in the previous 6 months before inclusion in study Exclusion criteria: history of chronic hypertension, kidney or cardiovascular disease, diabetes or past history of infections (apart from periodontal or HIV) Mean age (± standard deviation (years)): Group A = 24.7 ± 6.4, Group B = 27 ± 7.6 (P = 0.01) Mean gestational age at trial entry (weeks): Group A = 31.2, Group B = 32.4 History of preterm delivery: not reported Number randomised: n = 60 Number evaluated: n= 60 |
|
| Interventions |
A) Antenatal periodontal treatment (n = 28): between 26 and 34 weeks supragingival and subgingival cleaning with ultrasonic and manual devices (oral health education, hygiene, dental plaque removal, scaling and root planing (if necessary), subgingival irrigation without antibiotic administration in 1 single session of 1 to 2 hours) B) Postnatal periodontal treatment (n = 32): at 48 hours postpartum Periodontal treatment was performed by periodontists |
|
| Outcomes | Progression from mild to severe pre‐eclampsia; eclampsia or HELLP syndrome; number of days of clinical stability; percentile of birth weight adjusted for gestational age; preterm birth; probing depth; clinical attachment level; gingival bleeding (at probing) | |
| Funding | No funding source reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomised by blocks" Comment: no further details |
| Allocation concealment (selection bias) | Low risk | Quote: "Treatment intention was determined at random, in closed envelopes prepared by professionals external to the research group" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Periodontists did not know the objectives of the research" Comment: this was not considered as adequate blinding |
| Blinding of obstetric outcome assessment (detection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
| Selective reporting (reporting bias) | Low risk | Periodontal health outcomes on the same population were reported in a linked article (Contreras A, Botero J, Jaramillo A, Soto J, Velez S, Herrera JA. Effects of periodontal treatment on the preterm delivery and low weight newborn in women with preeclampsia ‐ clinical controlled trial. Revista Odontológica Mexicana 2010;14(4):226‐30) |
| Other bias | High risk | More (57% (16/28)) of women in the treatment group had chronic mild periodontitis compared with 37% (12/32) in the control group. There were also differences in age and gestational age at entry |