February 16, 2011 (San Francisco, California) — A small controlled clinical trial has found that when pregnant women with periodontal disease use an antibacterial mouth rinse twice a day, the incidence of preterm birth decreases by more than 15%. Women who used a nonalcoholic mouth rinse (Crest Pro-Health, Proctor and Gamble) were also more likely to deliver infants of higher gestational age and higher birth weight, according to research presented here at the Society for Maternal-Fetal Medicine 31st Annual Meeting.
The trial is the first to test an antibacterial mouth rinse as an intervention to prevent prematurity, according to presenting author Marjorie Jeffcoat, DMD, from the University of Pennsylvania in Philadelphia. "We were surprised at the magnitude of the outcome. When something as simple as a mouth rinse can change outcomes, it's pretty exciting," she said.
The study involved women at between 6 and 20 weeks of pregnancy with periodontal disease who refused standard periodontal treatment during their pregnancy. Seventy-one women used the dental mouth rinse (rinse group) and 155 received usual prenatal care (control group). The women were stratified according to whether or not they had experienced a previous preterm birth and whether they had a history of smoking. Most of the subjects were African American, had at least a high-school diploma, and were nonsmokers. In the rinse group, 28% of the women had experienced a previous preterm birth; in the control group, 30% had. Of these, 20% had more than 1 previous preterm birth. "This was a very high-risk group," Dr. Jeffcoat said.
At baseline, there was no difference in the severity of periodontal disease between the 2 groups. To be included in the study, the women had to have 3 or more tooth sites with 4 mm or more attachment loss. The mouth rinse used in the study is a broad-spectrum antimicrobial with cetylpyridinium chloride that remains in the oral cavity for long periods, Dr. Jeffcoat said. Crest Pro-Health is the only antimicrobial mouth rinse on the market without alcohol, she added.
The women in the rinse group were instructed to rinse their mouth with half an ounce twice a day for 30 seconds each time. Adherence was assessed through the return of empty bottles of the dental rinse.
Results revealed that the incidence of preterm birth at less than 35 weeks was 6.1% in the rinse group and 21.9% in the control group (P = .01). In the intent-to-treat analysis, the relative risk for preterm birth was 0.26 in the rinse group. The mean gestational age in the rinse group was significantly higher than in the control group (38.4 vs 36.8 weeks; P < .011). The analysis also showed that the mean birth weight in the rinse group was significantly higher than in the control group (3087 vs 2633 g; P < .001).
Dr. Jeffcoat emphasized that the study was not designed to test the additive effect of an antimicrobial mouth rinse with conventional dental scaling and root planing. Future research into the mouth rinse and its effect on preterm birth in women with periodontal disease could include large multicenter controlled clinical trials, as well as assessment of the mouth rinse's mechanism of action, she said.
"The relationship between periodontal disease and preterm birth has been shown repeatedly in other people's work," said Roger Newman, MD, professor and vice chair of the Department of Obstetrics and Gynecology at the Medical University of South Carolina in Charleston, who chaired the session at which the research was presented. "It's the first study to show the ability to intervene with mouth rinse to reduce the risk of prematurity, so it's provocative work. It's pilot research, although I think that other researchers will follow-up on the findings," Dr. Newman said.
Dr. Newman also noted that it will be necessary to assess the safety of the rinse before recommending it to pregnant women in their first trimester. "It's hard to imagine that if you take something that's long-acting that there won't be some absorption. That's a question that still needs to be answered," he said.
The study was funded by Procter and Gamble and the Commonwealth of Pennsylvania. Dr. Jeffcoat and Dr. Newman have disclosed no relevant financial relationships.
Society for Maternal-Fetal Medicine (SMFM) 31st Annual Meeting: Abstract 51. Presented February 11, 2011.
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