The Effect of Non-surgical Periodontal Therapy on Adverse... | NCT03126006

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

NCT03126006

Sponsor

Aga Khan University

Status

Completed

Last Update Posted

Jun 28, 2018Actual

Enrollment

115Actual

Phase

Not Applicable

Conditions

Birth Weight
Birth, Preterm

Interventions

NSPT plus oral hygiene
Oral hygiene alone

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2015Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Sep 1, 2017Actual

First Submitted Date

Apr 19, 2017

First Submission Date that Met QC Criteria

Apr 21, 2017

First Posted Date

Apr 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2018

Last Update Posted Date

Jun 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSPT plus oral hygiene	Experimental	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
Oral hygiene alone	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NSPT plus oral hygiene	Procedure	Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus	NSPT plus oral hygiene

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women only

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zaubina U Kazi, BDS, MSc	Aga Khan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aga Khan University		Karachi	Sindh	74800	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001724	Birth Weight
D047928	Premature Birth

Ancestor Terms

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007752	Obstetric Labor, Premature

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009910	Oral Hygiene
D014080	Tooth Exfoliation
D012534	Dental Scaling
D057747	Periodontal Debridement
D006920	Hygiene

Ancestor Terms

ID	Term
D013812	Therapeutics
D011313	Preventive Dentistry
D003813	Dentistry
D009063	Dental Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided

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.