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

Primary Purpose

Birth Weight, Birth, Preterm

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
NSPT plus oral hygiene
Oral hygiene alone
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Birth Weight

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NSPT plus oral hygiene

Oral hygiene alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Premature birth
less than 37 weeks

Secondary Outcome Measures

Birth weight
less than 2500grams
Still birth
To be assessed by the birth attendant/ Obgyne

Full Information

First Posted
April 19, 2017
Last Updated
June 27, 2018
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT03126006
Brief Title
The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes Randomized Controlled Trial
Acronym
NSPT
Official Title
The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Weight, Birth, Preterm

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NSPT plus oral hygiene
Arm Type
Experimental
Arm Description
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.
Arm Title
Oral hygiene alone
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
NSPT plus oral hygiene
Other Intervention Name(s)
scaling, dental scaling, de-scaling, periodontal prophylaxis, periodontal debridement
Intervention Description
Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus
Intervention Type
Other
Intervention Name(s)
Oral hygiene alone
Intervention Description
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 Outcome Measure Information:
Title
Premature birth
Description
less than 37 weeks
Time Frame
To be assessed at birth
Secondary Outcome Measure Information:
Title
Birth weight
Description
less than 2500grams
Time Frame
To be assessed at birth
Title
Still birth
Description
To be assessed by the birth attendant/ Obgyne
Time Frame
To be assessed at birth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaubina U Kazi, BDS, MSc
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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