The Impact of Scaling, Deep Cleaning, and Nutritional Supplementation on Adverse Pregnancy Outcomes, Placental Infection Prevention, and Gum Health Improvement in Pregnant Women

Effect of non-surgical periodontal intervention and nutritional supplementation on incidence of adverse pregnancy outcomes, colonization of fetoplacental unit by oral bacteria, levels of pro-inflammatory biomarkers and periodontal health: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079101

Enrollment

280

Registered

2025-01-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium

Interventions

Intervention1: OHI+ NSPT: Oral Hygiene Instructions (OHI) + Non-Surgical Periodontal Intervention (NSPT). All participants will receive a 15-minute oral health session at baseline, including verbal,

T1: 10 weeks after intervention (28-32 weeks of gestation)

T2: At the first post-partum visit

Td: At the time of delivery. The investigator will perform the NSPT through one to four sessions of scaling and root planing by quadrant, under local anesthesia (if required), within a period of 14 d

Td: At the time of delivery. Intervention2: OHI+ NSPT+ Nutritional Supplementation: OHI + NSPT + nutritional supplementation with 650mg omega-3 fatty acids capsules. All participants will receive a 1

Eligibility

Inclusion criteria

Inclusion criteria: Eligibility criteria: 1. 18-22 weeks of gestation 2. Minimum of 20 natural teeth 3. Presence of periodontal disease 4. Subjects willing to give informed written consent

Exclusion criteria

Exclusion criteria: Eligibility criteria: 1. Any other systemic disease like cardiovascular problems, diabetes, chronic renal diseases. human immunodeficiency virus (HIV) infection, viral infections, venereal infections, toxoplasmosis etc. 2. Current use of corticosteroids 3. Intention to deliver at a hospital other than the study setting 4. Multiple gestations 5. Previous preterm low birth weight/previous miscarriage 6. Alcoholism/ drug abuse/tobacco smoking

Design outcomes

Primary

Measure	Time frame
Primary outcomes that will be measured are preterm birth and low birth weight.Timepoint: Follow-up of all 280 participants will be done at timepoint Td (At the time of delivery )	—

Secondary

Measure	Time frame
The secondary outcomes are the clinical parameters and the cost parameters. The clinical parameters include periodontal health status assessed using Oral Hygiene Index- Simplified (OHI-S), Gingival recession (GR), periodontal probing depth (PD) and bleeding on probing (BOP). Additionally, saliva and blood samples will be collected from selected patients for analysis of inflammatory biomarkers and saliva/ dental plaque samples for periodontal microbiome analysis. Evaluation of the microbial analysis will also be done from the fetoplacental tissue collected at the time of delivery Td.Timepoint: At Baseline T0:(18-22 weeks of gestation) T1: 10 weeks after intervention (28-32 weeks of gestation) T2: At the first post-partum visit Td: At the time of delivery	—

Measure

Time frame

The secondary outcomes are the clinical parameters and the cost parameters. The clinical parameters include periodontal health status assessed using Oral Hygiene Index- Simplified (OHI-S), Gingival recession (GR), periodontal probing depth (PD) and bleeding on probing (BOP). Additionally, saliva and blood samples will be collected from selected patients for analysis of inflammatory biomarkers and saliva/ dental plaque samples for periodontal microbiome analysis. Evaluation of the microbial analysis will also be done from the fetoplacental tissue collected at the time of delivery Td.Timepoint: At Baseline T0:(18-22 weeks of gestation) T1: 10 weeks after intervention (28-32 weeks of gestation) T2: At the first post-partum visit Td: At the time of delivery

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Countries

India

Contacts

Public ContactDr Arpit Gupta

Postgraduate Institute of Medical Education and Research

arpitg.in@gmail.com8826674284

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026