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

Birth Weight Clinical Trial

— NSPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126006
• Other study ID #: 3232-CHS-ERC-14
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: September 1, 2017

Study information

• Verified date: June 2018
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Birth, Preterm
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature birth	less than 37 weeks	To be assessed at birth
Secondary	Birth weight	less than 2500grams	To be assessed at birth
Secondary	Still birth	To be assessed by the birth attendant/ Obgyne	To be assessed at birth