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

NCT03126006 | Completed

• 1 other identifier: 3232-CHS-ERC-14
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth Weight; Birth, Preterm

Outcome Measures

Primary Outcomes (1)

• Premature birth

  less than 37 weeks

  To be assessed at birth

Secondary Outcomes (2)

• Birth weight

  To be assessed at birth

• Still birth

  To be assessed at birth

Study Arms (2)

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

NSPT plus oral hygiene PROCEDURE

Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus

Also known as: scaling, dental scaling, de-scaling, periodontal prophylaxis, periodontal debridement

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.

Oral hygiene alone

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Birth Weight; Premature Birth

Interventions

Oral Hygiene; Tooth Exfoliation; Dental Scaling; Periodontal Debridement; Hygiene

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Dentistry; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Prophylaxis; Periodontics; Public Health; Environment and Public Health

Study Officials

• Zaubina U Kazi, BDS, MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: February 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)