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Periodontitis and Adverse Pregnancy Outcomes in Metabolic Syndrome Patients- Interventional Study

NCT03381469 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-02-13

No results posted yet for this study

Summary

Aim The Aim of the current study is to establish the association between periodontitis and adverse pregnancy outcomes in metabolic syndrome (Mets) patients and to evaluate the effect of intervention.

Objectives

1. To evaluate the changes in periodontal status of pregnant women with metabolic syndrome after non surgical periodontal therapy (NSPT)
2. To evaluate the inflammatory marker levels in serum of pregnant women with metabolic syndrome after non surgical periodontal therapy
3. To evaluate the effect of NSPT on adverse pregnancy outcomes of women with metabolic syndrome

Conditions

  • Low Birth Weight Baby
  • Metabolic Syndrome
  • Pregnancy Complications
  • Adverse Pregnancy Outcomes
  • Periodontitis
  • Premature Birth

Interventions

PROCEDURE

Comprehensive periodontal treatment

The Case group participants will receive non-surgical periodontal therapy that will be completed by the end of week 20-21 of gestation. This will consist of oral hygiene instruction with comprehensive periodontal treatment which will include excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth followed by supragingival and subgingival scaling and root planing (SRP) of sites with PDs \> 4 mm and polishing of all the teeth. Participants will be offered treatment under local anesthetic when necessary. No limits will be imposed on the number of dental visits needed to accomplish periodontal therapy.

PROCEDURE

single visit supragingival scaling

The control and Placebo group participants will receive oral hygiene instruction and supragingival cleaning of all teeth at their baseline visit.

Sponsors & Collaborators

  • Riyadh Colleges of Dentistry and Pharmacy

    lead OTHER

Principal Investigators

  • Hezekiah Mosadomi, DMD · Riyadh Colleges of Dentistry and Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-10
Primary Completion
2018-08-01
Completion
2018-12-01

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381469 on ClinicalTrials.gov