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

NCT ID: NCT03126006

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2017-09-01

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.

Conditions

Birth Weight; Birth, Preterm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

NSPT plus oral hygiene

Intervention Type: PROCEDURE

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

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.

Group Type: OTHER

Oral hygiene alone

Intervention Type: 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.

Interventions

NSPT plus oral hygiene

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

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Other Intervention Names

scaling, dental scaling, de-scaling; periodontal prophylaxis, periodontal debridement

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Farhan Raza Khan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zaubina U Kazi, BDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Aga Khan University

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

3232-CHS-ERC-14

Identifier Type: -

Identifier Source: org_study_id