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

Sponsor

Aga Khan University (Other)

Overall Status

Completed

CT.gov ID

NCT03126006

Collaborator

(none)

115

Enrollment

Location

Arms

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Birth Weight Birth, Preterm	Procedure: NSPT plus oral hygiene Other: Oral hygiene alone	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

115 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.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 :

Feb 1, 2015

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Premature birth [To be assessed at birth]
less than 37 weeks

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aga Khan University	Karachi	Sind	Pakistan	74800

Sponsors and Collaborators

Aga Khan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Farhan Raza Khan, Assistant Professor, Aga Khan University

ClinicalTrials.gov Identifier:

NCT03126006

Other Study ID Numbers:

3232-CHS-ERC-14

First Posted:

Apr 24, 2017

Last Update Posted:

Jun 28, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Birth Weight

Study Results

No Results Posted as of Jun 28, 2018