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Prenatal Gingivitis Prevalence In A Clinical Trial Exploring Oral Hygiene Education

Prenatal Gingivitis Prevalence In A Clinical Trial Exploring Oral Hygiene Education


Gingivitis is a very common oral condition affecting adults today. A major cause of gingivitis is dental plaque, which is often associated with poor oral brushing and/or flossing habits. Hormonal changes and some other factors have also been observed to play a role in the onset and/or severity of gingivitis. 

The prevalence of gingivitis among pregnant women ranges from 36% to 100%. The 2017 World Workshop on the classification of periodontal disease diagnosed gingivitis associated with pregnancy as dental plaque-induced gingivitis modified by systemic factors and linked to steroid/sex hormones.

In a systematic review involving several studies of gingival inflammation occurring in pregnancy, it was found that the rate of gingival inflammation is significantly increased throughout pregnancy, compared to the rate in non-pregnant women. This increase is seen to be proportional to inflammatory biomarkers and systemic hormone levels associated with pregnancy. Increases in the severity of gingivitis in pregnancy are transient and may be self-limiting. Additionally, hormonal changes reduce during the postpartum period, leading to a decline in the severity of gingival inflammation to non-pregnant levels provided oral health hygiene remains the same.

Interventions for gingivitis in pregnancy represents a time for health care providers like midwives to educate pregnant women on good oral hygiene practices due to the low prevalence of adequate oral hygiene habits in the general population. Improved oral hygiene in pregnant mothers and regular attendance to antenatal visits has been shown to lead to an improvement in the oral hygiene of their children including reduced rate of childhood caries. This approach is advantageous because it is better implemented and included in perinatal healthcare services.

Due to the probable effect of adequate oral hygiene and plaque removal during pregnancy on health in general, two pilot studies were introduced to assess other mechanisms to improve oral health at home. 

The first study reported that an oral rinse with non alcoholic cetylpyridinium chloride led to a decrease in the incidence of premature or preterm deliveries among pregnant women with periodontal disease and poor oral hygiene.

The second study included education and use of advanced products for oral hygiene in addition to the initial intervention in pregnant women with moderate to severe gingivitis. Results showed an improvement in the women’s periodontal health with the intervention.

This randomized trial was carried out based on the findings from these pilot studies including other studies related to the effect of a combination of oral health products on oral health.

The principal aim of this controlled randomized trial is to evaluate the efficiency of oral health interventions (OHI) including advanced over the counter (OTC) medications, oral health instructions given by nursing staff and educational videos on improving gingival inflammation during pregnancy in women with moderate to severe gingivitis.



Gingivitis is a condition characterized by inflammation of the gum or gingiva. It is a mild form of gum disease, which if left untreated can progress to more serious forms such as periodontitis.

Inadequate oral hygiene is a leading cause of gingivitis owing to the progressive accumulation of plaque resulting in inflammation to the gum or gingiva. 

However, in pregnancy there is a significant variance in the dental plaque biofilm composition which is not in uniformity with the increased inflammation present. This is because the hormonal changes associated with pregnancy lead to an increased inflammatory reaction in response to the accumulated biofilm of dental plaque without changes to dental hygiene.

Gingivitis is best treated via daily careful removal of plaque biofilm from the gingiva. Although hormone changes and inflammation associated with pregnancy have been shown to contribute to gingivitis, pregnancy associated gingivitis is rare in cases where dental plaque is well removed and controlled. Also, pregnancy associated with gingivitis, despite the influence of hormones, can be reversed with good oral care and hygiene regimen.

Furthermore, pregnancy has been demonstrated to offer a unique opportunity for women to adopt good oral health habits.

Periodontal Disease

Periodontal disease, also called periodontitis, is a severe form of gum disease characterized by intense inflammation and destruction to the jawbone.

Periodontal disease occurring during pregnancy has been stated to result in pregnancy outcomes like preterm birth and low birth weight. Exposure to systemic microbes and resulting inflammation associated with periodontal disease is hypothesized to be the underlying mechanism for these pregnancy outcomes. The efficacy of treatment for periodontal disease on the outcome of pregnancy has however been inconsistent.


This study was conducted in accordance to the 2013 Helsinki Declaration of 1975, and was registered on Furthermore, this research was approved by the University of Pennsylvania (UPenn) Institutional Review Boards and University of Alabama at Birmingham (UAB).

The clinical trial employed a controlled, randomized, multicenter, single masked, parallel two-treatment group design to adequately assess gingivitis in relation to maternal outcomes in 750 participants.

These participants were grouped into two daily oral health habits.

The reports on perinatal outcomes in these participants are not covered in this text, and are documented separately.

The setting of this research involved two antenatal clinic centers, one of which was at the Penn Obstetric/Gynecology clinic and associates in affiliation with University of Pennsylvania, the second clinic being the center for women’s reproductive health at University of Alabama in Birmingham.

750 pregnant women were enrolled to achieve a number of 600 evaluable participants. The participants were further classified into two groups with each group containing 300 participants aimed at increasing the power for subset analysis. Owing to the sample size, a power of 90% was yielded to detect a 0.05 between group difference in gingivitis using two sided testing.

Enrollment commenced in April 2012, while the last dental visit was concluded in April 2014. 

Informed consent was obtained from all participants, after which they were randomly grouped into one of the two oral hygiene procedures via a program which is  computer generated to balance the groups on the basis of factors like smoking status, previous preterm births and the number of gingival (intraoral) bleeding sites.

353 participants were enrolled at University of Pennsylvania (UPenn), while 295 participants were enrolled at University of Alabama in Birmingham (UAB).

The study involved four oral health hospital visits which are as follows:

  1. The first visit; which is the baseline visit with randomization of oral hygiene treatment.
  2. Second visit happening at week 4 or first month.
  3. Third visit occurring at week 8 or second month.
  4. Fourth visit occurring in the third month.

Monthly perinatal care was carried out in conjunction with hospital visits.

Examiners who were masked conducted careful oral examinations and assessment of dental plaques and evidence of periodontal disease. Gingival inflammation was assessed using the Löe and Silness Gingival Index (LSGI), and the number of intraoral bleeding sites assessed by individual tooth site scores. Periodontal probing depth was measured in the nearest millimeter using the periodontal probe.

Outcomes of pregnancy were also assessed by masked examiners.

Each study center had participants randomized to either a control group or an Oral Health Intervention (OHI) group. 

The OHI group were given an oral health kit which had a power toothbrush, 0.0454% fluoride toothpaste, dental floss and 0.07% non-alcoholic CPC oral rinse. Additionally, participants in the OHI group were made to watch a four minute long educational video on oral hygiene, demonstrating a two minute daily use of the provided toothbrush and toothpaste, oral rinse and floss.

The standard control group were given a kit containing 0.243% fluoride toothpaste, manual toothbrush and dental floss, with vocal or written oral hygiene instructions on twice daily brushing and daily flossing.

Inclusion Criteria

Each clinic targeted participants who were 8 to 24 weeks pregnant, at the age of legal consent with at least 20 natural teeth, having moderate to severe gingivitis (with at least 30 bleeding sites intraorally).

Exclusion Criteria

Women who had multifetal or twin pregnancies, HIV infection, AIDS infection, diabetes mellitus, autoimmune diseases and severe periodontal disease or dental conditions requiring urgent care were excluded from the trial.

Women who were to take antibiotics, before the dental procedure or immunosuppressant medications and corticosteroids one month within the baseline, or have allergies to mouth rinse products containing cetylpyridinium chloride (CPC) were also excluded from the trial. 


A total of 817 participants submitted an informed consent, from which 71 were deemed ineligible and 59 excluded as they did not meet the criteria.

746 participants were included in the trial and given baseline assessment and treatment randomization. Extra 80 participants at one test center (40 from each treatment group) were excluded from the study due to certain deviations noted at baseline assessments.

Ultimately, 648 participants were left and included in the outcome reports.

Some other factors like missing hospital visits, miscarriages or deliveries led to the loss of evaluable participants in the final outcome study.

548 participants completed dental exams in the first month while 532 completed exams in the third month.

Mean age of participants is 27.6 years and mean gestational age at 17 weeks.

Black women made up two thirds of the sample size.

The mean whole mouth LSGI score was 1.3, the mean number of intraoral bleeding sites being 51.1, while the mean probing depth (PD) was 2.5mm.

Study centers differed in age, race, tobacco use demography and dental insurance of participants.

Results of Oral Interventions

Maternal age at baseline showed a significant relationship with the number of baseline intraoral bleeding sites.

However, gestational age at baseline was not related or linked to the number of baseline intraoral bleeding sites.

Compared to baseline values, the two treatment groups showed a reduction in gingivitis starting from the first month.

The number of intraoral bleeding sites were improved by 35% to 39% after the first month of treatment reaching 43% to 47% by the third month.

Bother treatment groups showed an improvement in the probing depth by the first month to the third month.

The OHI group showed more improvement and reduction in LSGI scores, intraoral bleeding sites, probing depths and gingivitis by the first month compared to the standard group.

Adverse Effects

81 participants suffered adverse effects as a result of the treatment, with 91 suffering oral and perioral adverse effects. These most common adverse effects were; fracture of the tooth, oral mucosal exfoliation, and discoloration of tooth. These adverse effects were more in the OHI group (15%) than the standard treatment group (10%).


This study demonstrated the prevalence and severity of gingivitis in pregnancy. These values were significant and cut across study sites, socioeconomic status and demographic subgroups.

Oral health education is very vital in preventing and treating gingivitis and periodontal disease in pregnant women and the general population as a whole. It is thus important to include oral hygiene education as a part of antenatal care services, as the hormonal changes associated with pregnancy have been shown to play a role in the onset of gingivitis.


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