Jeffcoat 2003.
| Methods |
Study design: RCT Location: USA Setting: Periodontal Clinic, University of Alabama School of Dentistry, Alabama, USA Recruitment period: not stated |
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| Participants |
Inclusion criteria: pregnant women between 21 and 25 weeks gestational age; screened for ≥ 3 sites clinical attachment loss ≥ 3 mm; ambulatory; willingness to participate and give consent Exclusion criteria: women participating in any other treatment study; undergoing periodontal therapy; taking antibiotics during pregnancy; or using antibiotic mouthrinse; requiring treatment for bacterial vaginosis Mean age (± standard deviation (years)): Group A = 22.2 ± 4 .3, Group B = 22.8 ± 4.6, Group C = 22.4 ± 5 (P = 0.62) Gestational age at trial entry: 21 to 25 weeks (P = not reported) History of spontaneous preterm birth < 35 weeks, n (%): Group A = 6 (4.9%), Group B = 5 (4.1%), Group C = 4 (3.3%) (P = 0.83) Number randomised: n = 368 Number analysed: n = 366 (attrition n = 2 participants delivered elsewhere) |
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| Interventions |
A) Antenatal periodontal treatment ‐ SRP + placebo capsule (n = 123): scaling and root planing was performed according to usual clinical procedures and clinicians were instructed to spend as much time and as many visits as needed B) Antenatal periodontal treatment ‐ SRP + metronidazole capsule (n = 120): metronidazole was taken 250 mg 3 times a day for 1 week. Scaling and root planing was performed according to usual clinical procedures and clinicians were instructed to spend as much time and as many visits as needed C) Antenatal periodontal treatment ‐ Dental prophylaxis + placebo capsule (n = 123): tooth cleaning and polish (supragingival scaling and rubber cup polish) + placebo capsule 3 times daily All women: received oral hygiene instructions from a dental hygienist and supplies of toothbrushes, dental floss and fluoride toothpaste Dental hygienists carried out examinations at baseline supervised by periodontists. SRP was administered by "clinicians" |
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| Outcomes | Preterm birth rate (< 35 weeks); preterm birth rate (< 37 weeks) Intention‐to‐treat analysis was applied and the prevalence of preterm birth calculated for each of the 3 randomised treatment groups |
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| Funding | Not stated | |
| Notes | Stratification by BMI (< 19.8 versus ≥ 19.8); presence of bacterial vaginosis as assessed by Gram stain; previous spontaneous birth prior to 35 weeks gestation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "University research pharmacist generated the randomisation code" |
| Allocation concealment (selection bias) | Low risk | Pharmacist provided a double packet with coding information for each participant ‐ the code did not need to be broken during the study |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study was placebo‐blinded and code breaking seems to have occurred only at the end of the study |
| Blinding of obstetric outcome assessment (detection bias) | Low risk | Quote: "The clinicians delivering periodontal care had no role in determining the outcome of the study... research obstetric nurses abstracted maternal records to determine the predefined age at delivery. These abstractors were completely blinded as to the periodontal status or the patients' periodontal treatment" Comment: outcome seems to have been assessed by different personnel from caregivers |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There were only 2 dropouts and intention‐to‐treat analysis was applied |
| Selective reporting (reporting bias) | High risk | Periodontal health outcome was not reported |
| Other bias | Low risk | No other apparent biases |