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

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ClinicalTrials.gov Identifier: NCT03126006
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Farhan Raza Khan, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Birth Weight Birth, Preterm Procedure: NSPT plus oral hygiene Other: Oral hygiene alone Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes: A Randomized Controlled Trial
Actual Study Start Date : February 1, 2015
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


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

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.




Primary Outcome Measures :
  1. Premature birth [ Time Frame: To be assessed at birth ]
    less than 37 weeks


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women only
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126006


Contacts
Contact: Farhan R Khan, FCPS farhan.raza@aku.edu
Contact: Zaubina U Kazi, BDS, MSc zaubina.kazi@aku.edu

Locations
Pakistan
Aga Khan University Recruiting
Karachi, Sind, Pakistan, 74800
Contact: Farhan R Khan, FCPS       farhan.raza@aku.edu   
Contact: Zaubina Kazi, BDS       zaubina.kazi@aku.edu   
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Zaubina U Kazi, BDS, MSc Aga Khan University

Responsible Party: Farhan Raza Khan, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03126006     History of Changes
Other Study ID Numbers: 3232-CHS-ERC-14
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Birth Weight
Premature Birth
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications