NCT01549587.

Methods	Single‐blind RCT
Participants	Inclusion criteria: provide written informed consent prior to participation and be given a signed copy of the informed consent form; be at least the age of legal consent; be between 8 and 24 weeks of pregnancy; have at least 20 natural teeth; have moderate‐to‐severe gingivitis during pregnancy, including at least 30 intraoral sites with evidence of marginal gingival bleeding
Interventions	Active comparator: regular oral hygiene. Toothpaste, toothbrush and dental floss. Interventions: drug: 0.243% sodium fluoride; device: toothbrush; device: dental floss Experimental: advanced oral hygiene + counselling. Toothpaste, toothbrush, mouthrinse and dental floss + specialized education. Interventions: drug: 0.454% stannous fluoride; device: toothbrush; drug: 0.07% cetylpyridinium chloride; device: dental floss
Outcomes	Gestational age (weeks); neonate birth weight (grams); preterm birth (gestational age < 37 weeks)
Notes	Reported on clinical registry as completed in April 2014 ‐ study not available

RCT = randomised controlled trial.