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

The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes: A 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.

Study Overview

• Status: Completed
• Conditions: Birth Weight; Birth, Preterm
• Intervention / Treatment: Procedure: NSPT plus oral hygiene; Other: Oral hygiene 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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan, 74800
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NSPT plus oral hygiene; It includes pregnant women (with periodontal disease) who will be subjected to one episode of non-surgical periodontal therapy under local anesthesia during pregnancy. they will receive oral hygiene instruction also.	Procedure: NSPT plus oral hygiene; Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus; Other Names: scaling, dental scaling, de-scaling; periodontal prophylaxis, periodontal debridement
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature birth	less than 37 weeks	To be assessed at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth weight	less than 2500grams	To be assessed at birth
Still birth	To be assessed by the birth attendant/ Obgyne	To be assessed at birth

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Zaubina U Kazi, BDS, MSc, Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Birth Weight
• Other Study ID Numbers: 3232-CHS-ERC-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No