RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / Dr. PRIJITHA ALEX
POST GRADUATE STUDENT
THE OXFORD DENTAL COLLEGE AND HOSPITAL,
BOMMANAHALLI, HOSUR ROAD, BANGALORE-560068
2. / NAME OF THE INSTITUTION / THE OXFORD DENTAL COLLEGE AND HOSPITAL, BOMMANAHALLI, HOSUR ROAD, BANGALORE-560068.
3. / COURSE OF STUDY AND SUBJECT / MASTER OF DENTAL SURGERY

PUBLIC HEALTH DENTISTRY

4. / DATE OF ADMISSION TO COURSE /

25th MAY 2012

5. /

TITLE OF THE TOPIC

/ “ASSOCIATION BETWEEN PERIODONTITIS, ITS DETERMINANTS AMONG PREGNANT WOMEN WITH THEIR NEONATAL ANTHROPOMETRIC STATUS – A COHORT STUDY IN BANGALORE CITY ”

BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY
Pregnancy demonstrates the deterministic character of a woman. A healthy pregnancy lays the foundation for the birth of a healthy baby. Pregnancy also affects a woman’s hormonal balance and acts as a modifying factor for the pathogenesis of periodontal disease. Although pregnancy does not cause periodontal diseases, numerous studies have confirmed higher incidence of gingivitis and attachment loss compared with their non-pregnant counterparts and prevalence rates vary between 36% to 100%.1,2 This is usually seen between the second and eight months of gestation reaching a peak at >26 weeks.3 Nevertheless, studies have also been reported on no difference in periodontal health between pregnant subjects and non- pregnant controls, leaving findings in this area inconsistent and conflicting.
Apart from the effects of hormonal changes, aggravated periodontal condition has been reported in pregnant women after adjusting for the effect of increasing age, personal hygiene, lack of dental care, smoking, low educational level, low employment status and changed psychological status. There is a lack of research on these socio-behavioral determinants of periodontal status among pregnant women particularly in developing countries. Recent meta-analytical reviews have reported a positive association between maternal periodontitis and adverse pregnancy outcomes such as prematurity, low birth weight and pre-eclampsia especially in low and middle income populations.1The term Anthropometry refers to comparative measurements of the body. Height, weight, weight-for-height, head circumference etc are used to assess growth and development in infants. Epigenetic challenges faced by the infant in the womb to a mother with poor periodontal health will lead to long term health outcomes.2
Thus the present study is set to describe the clinical and self reported aspects of periodontal health in relation to predisposing factors (age, education, parity, employment status, psychological status, lack of dental care) and enabling factors (antenatal care, information received about own teeth, child’s teeth) and to evaluate the association between periodontal health of pregnant women >26 weeks of gestation and their neonatal anthropometric status[Height-for-age-Z-scores(HAZ), Weight-for-age-Z-scores(WAZ),Weight-for-height-Z-scores(WHZ )]at birth in terms of stunting, underweight and wasting.
6.2 REVIEW OF LITERATURE:
A study was done to assess the periodontal health and oral hygiene status of pregnant women and non-pregnant controls and to evaluate the effect of socio-demographic and other variables on periodontal status. A total of 400 women, of whom 200 were pregnant (mean age=30 years) and 200 non-pregnant controls (mean age=32 years) were chosen at random from four health centres. The clinical parameters used were the Silness and Loe plaque index (PI), Loe and Silness gingival index (GI), probing pocket depth (PPD), probing attachment level (PAL), any relationship to socio-demographic (age, level of education and professional level) and clinical variables (gestation period, previous pregnancy and vomiting during pregnancy) was evaluated. The results showed that pregnant women had significantly higher GI and PPD scores but with no statistically significant differences in PAL or PI compared with non-pregnant controls. Increased age, lower level of education and non-employment were associated with significantly higher GI and PPD scores. All these clinical parameters increased in reaching their maximum at the eighth month. Women with previous or multiple pregnancy had statistically significantly higher GI and PPD scores than those who were pregnant for the first time, but with no statistically significant differences in PI or PAL scores. Also, women who vomited during pregnancy had significantly higher GI and PPD scores compared with those who did not vomit. It was concluded that gingival inflammatory symptoms are aggravated during pregnancy and are related to increased age, lower level of education and non-employment.3
A study was conducted to describe the oral health of pregnant women, to determine oral health changes during pregnancy and to determine factors associated with maternal periodontal health or disease.1224 pregnant women at < 26 weeks gestation were enrolled in the study and oral health examinations were performed at enrollment and within 48 hours of delivery. Demographic, medical, and health behavior data were determined by chart abstraction and questionnaire. Among 903 women, there was a significant increase in those with health or periodontal disease absence between enrollment and delivery. A significant increase in women with four or more sites with attachment loss ≥2 mm or ≥3 mm was seen. Race, smoking, and insurance status were significantly associated with maternal periodontal disease. Black women were more likely than white women to have periodontal disease at enrollment and delivery and experienced incident disease. Oral health examinations were well accepted by pregnant women. An increase in attachment loss may represent active periodontal infection accelerated by pregnancy.4
A cross sectional study was conducted to assess periodontal disease as a risk factor for Low birth weight (LBW) with other multiple factors. Caucasian pregnant women (n=152), aged 14-39 years, were enrolled while receiving prenatal care. Dental plaque, probing depth, bleeding on probing and clinical attachment level were recorded and three groups were made- healthy group (HG) (n=38), gingivitis group (GG) (n=71) and periodontitis group (PG) (n=43). At delivery, birth weight was recorded. Infant mean weight at delivery was 3293.9+/-508.1 g. The total incidence of preterm birth and LBW infants was 5.3% and 4.6% respectively. The incidence of LBW infants was 3.5% in term gestations and 25% in preterm gestations. Mothers height correlated with infant birth weight (p=0.03). Significant difference in birth weight existed between mothers with <1.55 m (3229.23+/-462.57) and those with ≥1.55 m (3475.55+/-505.07). In the group of women >25 years old infant mean weight in HG was 3588.33+/-531.83, being lower in GG (3466.75+/-334.45) and even lower (3092.60+/-592.94) in PG (p=0.0198). Bleeding on probing was significantly greater in women with <2500 g infants (40.2+/-21.8%) compared with 2500-3499 g (18.6+/-15.1%) and ≥3500 g (17.1+/-16.1%) (p=0.009).Periodontal disease in normal Caucasian pregnant women, older than 25 years, is statistically associated with a reduction in the infant birth weight.5
A study was conducted to determine the association between maternal periodontitis and Low Birth Weight (LBW) infants among Malay women. Periodontal examinations were carried out on all eligible Malay pregnant women in the second trimester of pregnancy attending two randomly selected community maternal and child health clinics in Kota Bharu, Kelantan. Patients with four or more sites with pocket depth 4 mm or higher, and clinical attachment loss 3 mm or higher at the same site with presence of bleeding on probing were diagnosed as having periodontitis. Systematic random sampling was utilized for selection of 250 subjects for each exposed and non-exposed group. Of 500 subjects enrolled in the study, 28 (5.6%) were either dropped or lost to follow-up. Of the remaining 472 subjects, 232 with periodontitis were in the exposed group and 240 with healthy periodontium were in the non exposed group. The incidence of LBW was 14.2% in women with periodontitis, and 3.3% in women without periodontitis. The relative risk of having LBW infants was 4.27 times higher for women with periodontitis compared with those without periodontitis. The results of this study provide additional evidence that pregnant women with periodontitis are at a significantly higher risk of delivering LBW infants.6
A study was done to evaluate maternal periodontitis and its association with low birth weight children. This was a case-control study among 548 puerperae, of whom 164 were the mothers of low-weight live births (case group) and 384 were the mothers of live births of normal gestational weight (control group). They were selected at two public hospital units in two municipalities in the State of Bahia. From interviews and data gathered using live birth cards or birth certificates, information was obtained regarding age, height, previous diseases, marital status, socioeconomic situation, smoking and alcohol use. Mothers who presented at least four teeth on which one or more sites had a probing depth of ≥ 4 mm, clinical attachment loss of ≥ 3 mm and bleeding on probing, at the same site, were deemed to present periodontal disease. Periodontal disease was diagnosed in 42.7% of the case group and 30% of the control group. A statistically significant association was found between periodontal disease and low birth weight, particularly among mothers with low schooling levels .The findings suggest an association between periodontal disease and low birth weight among mothers with low education levels.7
A prospective cohort study was conducted in Mbale, Eastern Uganda to find the predisposing and enabling factors as determinants of oral health indicators in pregnancy as well as the association between periodontal problems at 7 months gestational age and the infants’ anthropometric status. 713 pregnant women completed interviews and a full mouth oral clinical examination using the CPITN (Community Periodontal Index of Treatment Need) and OHI-S (Simplified Oral Hygiene) indices. A total of 593 women were followed up with anthropometric assessments of their infants 3 weeks after delivery. The relationship between periodontal problems and the child’s anthropometric status in terms of wasting, underweight and stunting were investigated. A total of 67% of women presented with periodontal problems, 12.1% with poor oral hygiene and 65.0% with periodontal symptoms. Of the infants, 2% were wasted, 6.9% were underweight and 10.0% were stunted. The odds ratio of having CPI > 0 increased with increased maternal age and single marital status, and was lower in primiparous women. Mean wasting scores discriminated between mothers with CPI ≥ 0 as well as between mothers with good and poor OHI-S scores. Socio-demographic factors and information about oral health were associated with oral health indicators in pregnant women. Second, the height- for- age status at 3 weeks postpartum was worse in infants of mothers having periodontal problems and poor oral hygiene during pregnancy.1
7 / 6.3 OBJECTIVES OF THE STUDY:
1. To assess the periodontal status among pregnant women >26 weeks of gestation attending maternity hospitals in Bangalore city.
2. To describe the determinants of periodontal health in relation to predisposing and enabling factors.
3. To evaluate the association between periodontal status, its determinants among pregnant women and their neonatal anthropometric status.
MATERIALS AND METHODS
7.1 SOURCE OF DATA:
A cohort of pregnant women >26 weeks of gestation and their neonates from the maternity hospitals of Bangalore city.
7.2 METHOD OF COLLECTION OF DATA:
7.2.1 INCLUSION CRITERIA:
1.  Pregnant women >26 weeks of gestation
2.  Women who have conceived naturally
3.  Minimum of 20 teeth present
7.2.2 EXCLUSION CRITERIA:
1.High risk gestation(placenta previa, pre-eclampsia, eclampsia)
2.Any systemic illness including Gestational diabetes
3.Current use of corticosteroids
4.Who had undergone professional oral prophylaxis during the last one year
8. / 7.2.3 STUDY DESIGN:
A cohort study will be conducted at different maternity hospitals of Bangalore City. A formal approval letter from the hospital authorities will be obtained to carry out this study. Written consent will be taken from the individual subjects.
The sample size formula is:
n=Z2p(1-p)(DEFF)
d2
Standard Normal Deviation(Z) =1.96
Estimate of the expected proportion (p) =0.655
Desired level of absolute precision (d) =.05
Estimated design effect (DEFF) =1
The sample size obtained after substituting the above mentioned values in the formula is 347. To compensate for drop outs, the total sample size will be inflated to the final sample of 400. The pregnant women satisfying the inclusion criteria will be chosen for the study. The subjects will be given a structured questionnaire regarding self perceived predisposing and enabling factors of periodontal status both in English and local language. Periodontal status will be assessed using CPI index.8
At birth, the anthropometric status of their neonates will be measured. Anthropometric indices will be constructed on the basis of weight, height and sex. Wasting is defined as weight-for- height Z scores(WHZ)<-2SD,Stunting as height-for-age Z scores(HAZ)<-2SD and Underweight as weight-for-age Z scores(WAZ)<-2SD. This will be compared with The WHO Child Growth Standards.
Data thus obtained will be processed and analyzed using SPSS software; the following statistical tests will be used.
Ø  Chi-square test
Ø  Fischer’s exact test
Ø  Multiple regression analysis
If required any other suitable statistical methods will be used at the time of data analysis.
7.2.4 DURATION OF THE STUDY: 6 months.
7.3. Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
YES
The study requires oral examination of pregnant women.
7.4 Has ethical clearance been obtained from your institution in case of 7.3
YES (enclosed)
LIST OF REFERENCES:
1.  Margaret Wandera, Anne N Astrom, Issac Okullo, James K Tumwine. Determinants of periodontal health in pregnant women and association with infant’s anthropometric status: a prospective cohort study from Eastern Uganda. BMC Pregnancy and Childbirth 2012;12:90.
2.  Ananda P Dasanayake, Susan Gennaro, Karen D Hendricks-Munoz. Maternal periodontal disease, pregnancy and neonatal outcomes.MCN 2008 Jan/Feb;33:45-46.
3.  Taani DQ, Habashneh R,Hammad MM, Batieha A. The periodontal status of pregnant women and its relationship with socio-demographic and clinical variables. Journal of Oral Rehabilitation 2003;30:440-445.
4.  Lieff S,Boggess KA,Murtha AP,Jared H,Madianos PN,Moss K et al. The oral conditions and pregnancy study: periodontal status of a cohort of pregnant women. J Periodontol 2004;75:116-126.
5.  Marin C, Sequra-Eqea JJ, Martinez-Sahuquillo A, Bullon P .Correlation between infant birth weight and mother’s periodontal status. J Clin Periodontol 2005 March;32(3):299-304.
6.  Saddki N,Bachok N,Hussain NH,Zainudin SL,Sosroseno W. The association between maternal periodontitis and low birth weight infants among Malay women. Community Dent Oral Epidemiol 2008;36:296-304.
7.  Cruz SS, Costa MCN, Gomes-Filho IS,Rezende EJC,Barreto ML,Dos Santos CAST et al. Contribution of periodontal disease in pregnant women as a risk factor for low birth weight. Community Dent Oral Epidemiol 2009;37:527-533
8.  Oral Health Survey Basic Methods 4th Edition.