NCT03126006

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Birth Weight
• Birth, Preterm

Interventions

Type	Name	Description
PROCEDURE	NSPT plus oral hygiene	Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus
OTHER	Oral 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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-08-01
• Completion: 2017-09-01
• First posted: 2017-04-24
• Last updated: 2018-06-28

Locations

1 site across 1 country: Pakistan