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Completed

NCT Number: NCT03126006

The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes Randomized Controlled Trial

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NSPT plus oral hygiene

Procedure

Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus

Other names: scaling, dental scaling, de-scaling, periodontal prophylaxis, periodontal debridement

Oral hygiene alone

Other

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.

Primary outcomes

  1. Premature birth

    Time frame: To be assessed at birth

    less than 37 weeks

Secondary outcomes

  1. Birth weight

    Time frame: To be assessed at birth

    less than 2500grams

  2. Still birth

    Time frame: To be assessed at birth

    To be assessed by the birth attendant/ Obgyne

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes: A Randomized Controlled Trial

Acronym: NSPT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2017
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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