Birth, Preterm, Birth Weight
Conditions
Brief summary
The main objective of this study is to determine whether the provision of non-surgical periodontal therapy to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to pregnant women with periodontitis but who will be provided with oral hygiene instructions alone.
Detailed description
Approximately two-thirds of pregnant Pakistani women suffer from periodontal disease a common inflammatory disease of the soft tissues surrounding the tooth. It was demonstrated that periodontitis among pregnant women is significantly associated with preterm birth and low birth weight. Pakistan has a high prevalence of these adverse birth outcomes therefore; identifying an intervention is of prime importance and may have social and economic benefits. Non-surgical periodontal therapy is affordable and amenable to people and thus seems to be an intervention which may prove to be of benefit in a population where the dental services are available. It has been recommended in systematic reviews and Meta analysis that Randomized Controlled Trials are now required to establish whether the removal of inflammatory factors by scaling and root planning are effective in reducing adverse pregnancy outcomes such as preterm birth and low birth weight.
Interventions
PROCEDURENSPT plus oral hygiene
Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus
OTHEROral hygiene alone
It includes pregnant women (with periodontal disease) who will not be given any mechanical treatment such as non-surgical periodontal therapy during pregnancy. However, oral hygiene instructions will be given.
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
It's an assessor blinded, parallel group, randomized controlled trial aimed at determining the superiority of non-surgical periodontal therapy over no dental treatment among pregnant women. The main objective of this trial is to determine whether the provision of NSPT to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to the pregnant women who were subjected to no NSPT. Outcomes of interest are pre-term birth (\<37 weeks) gestation, low birth weight (\<2500g) or still birth with either one occurring being considered as a positive outcome.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant woman presenting to the Obstetric clinic at the Aga Khan Hospital for Women, Karimabad or the Aga Khan Hospital for Women and Children, Kharadar. * Participant should be between the ages of 18 and 35 years * Exhibiting at least 2 sites with 2mm or more periodontal probing depth. * Planning to deliver the baby at the above mentioned facilities so that the outcome can be observed and measured. * Singleton pregnancy. * Willing to get NSPT done between 20 to 28 weeks of gestation. * At least 20 teeth present in the mouth so that periodontal scoring could be done.
Exclusion criteria
* Tobacco or alcohol use. * Genitourinary tract infection or any systemic infection. * Obstetric disorders such as gestational diabetes or placenta previa or pre-eclampsia or eclampsia etc. * Chronic disease such as diabetes or blood pressure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premature birth | To be assessed at birth | less than 37 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth weight | To be assessed at birth | less than 2500grams |
| Still birth | To be assessed at birth | To be assessed by the birth attendant/ Obgyne |
Countries
Pakistan
Outcome results
None listed