Objective
We sought to determine if treatment of periodontal disease during pregnancy with an alcohol-free antimicrobial mouth rinse containing cetylpyridinium chloride impacts the incidence of preterm birth (PTB) in a high-risk population.
Study Design
This single-blind clinical trial studied pregnant women (6-20 weeks’ gestation) with periodontal disease who refused dental care. Subjects receiving mouth rinse were compared to designated controls who did not receive rinse (1 rinse:2 controls), balanced on prior PTB and smoking. Primary outcome was PTB <35 weeks.
Results
In all, 226 women were included in the analysis (71 mouth rinse subjects, 155 controls). Incidence of PTB <35 weeks was lower in the rinse group compared to controls (5.6% and 21.9% respectively, P < .01); relative risk was 0.26 (95% confidence interval, 0.096–0.70). Gestational age and birthweight were significantly higher in the rinse group ( P < .01).
Conclusion
A nonalcohol antimicrobial mouth rinse containing cetylpyridinium chloride was associated with decreased incidence of PTB <35 weeks.
There has recently been a focus on periodontal infection as a risk factor or risk indicator for preterm birth (PTB). The preponderance of the evidence indicates that maternal periodontal disease is associated with an increased incidence of PTBs. A mere association between clinical measures of periodontal disease and the incidence of PTB does not, however, imply that treating the periodontal disease by mechanical means (ie, scaling and root planing) will decrease the incidence of PTB. To address this important question, several intervention studies using scaling and root planing have been performed. The majority of single-center studies showed a reduction in PTB with periodontal treatment, while most multicenter intervention trials showed no effect.
Even if periodontal therapy is proven to be beneficial in reducing PTB, unequal access to, and underutilization of, dental care–especially complex periodontal treatment–may limit the impact of conventional treatment in populations at greatest risk for pregnancy complications. Further, it is known that mechanical cleaning of the teeth above and below the gum line puts the patient at increased risk for bacteremia and inflammatory mediators. This bacteremia, like those resulting from eating or toothbrushing, is short in duration and has not been shown to cause adverse events except for certain categories of patients at high risk for infection. Furthermore, initial or episodic periodontal care may not be sufficient to manage the extended periodontal needs of women throughout pregnancy.
The present paper focuses on an alternative but related hypothesis: that a topical, oral chemotherapeutic approach might be used to reduce bacterial plaque, gingival inflammation, and periodontal disease, without more extensive periodontal intervention. Daily use of an antimicrobial mouth rinse for bacterial control would be an attractive treatment modality because it could be easily implemented as part of routine at-home care without demanding special training or dexterity. Specifically, this study assessed whether the use of an alcohol-free, antimicrobial mouth rinse containing cetylpyridinium chloride (CPC) to treat periodontal disease would also decrease the incidence of spontaneous PTB <35 weeks’ gestational age (GA), relative to a control without mouth rinse.
Materials and Methods
Study design
This was a controlled single-blind clinical study. Dental and obstetric examinations were performed at baseline. Dental examinations were performed 3 and 6 months later (if the subject had not yet delivered) to assess periodontal health. Following delivery, GA and birthweight were abstracted from the medical records. Outcomes in subjects allocated to receive rinse were compared to controls who did not receive mouth rinse. The primary medical outcome of interest was spontaneous PTB <35 weeks’ GA. Pregnant women presenting for care at the Department of Obstetrics and Gynecology at the Hospital of the University of Pennsylvania were screened for the study. Those at 6-20 weeks’ GA who also had: (1) periodontal disease, defined as >3 sites with >4-mm attachment loss ; (2) refused mechanical dental care during pregnancy; and (3) no gynecologic infections were eligible for inclusion. Patients with bacterial vaginosis or sexually transmitted infections ( Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , herpes simplex virus) identified at their initial prenatal visit were excluded from participation in the trial. Bacterial vaginosis and T vaginalis were identified by the patients’ care providers by wet mount microscopic inspection (clue cells, flagellated organisms, respectively). C trachomatis and N gonorrhoeae were identified by routine clinical testing (RNA probes). Suspected herpes lesions were cultured. The presence of bacterial vaginosis or sexually transmitted infections was abstracted from the subjects’ outpatient records by study coordinators.
Patients having undergone periodontal therapy within the past year, taking antibiotics during pregnancy, already using antimicrobial mouth rinses, requiring antibiotic prophylaxis in connection with dental treatment, or participating in any other treatment study were excluded. The project was approved by the University of Pennsylvania Institutional Review Board for protection against research risks (protocol #806509). Informed consent was obtained in writing.
Rinse formulation and administration
Subjects in the rinse group were dispensed an alcohol-free, 0.07% CPC rinse (Crest Pro-Health; The Procter and Gamble Co, Mason, OH). The rinse is a highly bioavailable CPC product formulated in a nonhydroalcoholic base to promote antimicrobial delivery to the oral biofilm, and substantivity in the oral cavity. To facilitate product transport, all subjects were offered either a wheeled cart or home delivery via courier. Subjects were instructed to rinse twice daily (after regular toothbrushing) for 30 seconds with 20 mL of the supplied rinse, followed by expectoration. All rinse use was at home and unsupervised.
Home instructions for oral hygiene and supplies
All subjects received oral hygiene instructions from a dental hygienist, as well as home care supplies (toothbrushes, dental floss, and fluoride toothpaste). Control subjects were instructed to rinse with water while the rinse subjects rinsed with the test rinse. Supplies were replenished as needed. Subjects in need of additional periodontal care after delivery were offered appropriate treatment.
Stratification
Subjects were categorized into the following strata:
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History of PTB and smoking.
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No history of PTB and smoking.
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History of PTB and no smoking.
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No history of PTB and no smoking.
Four strata, together with a specified 1:2 ratio of rinse to control subjects, implies a block size of 12. A computer-generated pseudorandom assignment sequence was used to designate at least 2 matched control subjects for every rinse subject. Using this approach, a total of 246 subjects were evaluated, including 81 assigned the antimicrobial rinse, and 165 untreated controls.
Obstetric care
All subjects included in the analysis received obstetric care according to departmental guidelines from the Department of Obstetrics and Gynecology at the Hospital of the University of Pennsylvania. Subjects who, in the judgment of the obstetric team, required care for any medical or obstetric condition (eg, bacterial vaginosis infection) were offered appropriate care. The length of the pregnancy was determined using standard dating criteria, including vaginal ultrasound. Subjects in need of care for infections at baseline (eg, recent Chlamydia or gonorrhea infections) were not eligible to participate in this study.
Periodontal examinations
Periodontal examinations were performed at baseline and at 3 and 6 months later. Probing pocket depth and bleeding on probing were measured at 6 sites per tooth at each examination. Women in urgent need of dental care were so informed, but were not eligible to participate in this study.
Pregnancy outcomes–primary outcome for the study
A member of the research team who had not personally examined any of the subjects retrieved the GA of the infant from the hospital record after delivery. The primary medical outcome of the study was spontaneous PTB at <35 weeks’ GA. Secondary outcomes included GA and birthweight at delivery.
Statistics
Subjects who were assigned the test rinse were compared to the designated controls. Descriptive statistics by treatment group were calculated for the recorded parameters. Groups were compared using analysis of variance with fixed effects and age as a covariate. Relative risk and 95% confidence intervals were calculated for spontaneous PTB <35 weeks.
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