Clinical trial NCT03126006: The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes Randomized Controlled Trial
Official title: The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Weight
Birth, Preterm
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Premature birth
timeFrame: To be assessed at birth
Secondary outcomes:
measure: Birth weight
timeFrame: To be assessed at birth
measure: Still birth
timeFrame: To be assessed at birth
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sind
Study officials:
affiliation: Aga Khan University
name: Zaubina U Kazi, BDS, MSc
role: PRINCIPAL_INVESTIGATOR
References: