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To observe the effect of scaling in pregnant females with a history of preterm birth and gum disease.

Effect of reducing systemic inflammation associated with periodontal disease on subsequent pregnancy outcomes in females with previous history of preterm delivery in Tricity population - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102895
Enrollment
30
Registered
2026-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

None listed

Interventions

Intervention1: Professional oral prophylaxis and supportive periodontal therapy: Professional oral prophylaxis and supportive periodontal therapy in second trimester of pregnancy in females having sin

Sponsors

Dr Ashish Jain
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Pregnant females in their 21st to 24th week of pregnancy. 2. With a singleton pregnancy 3. Bearing their second offspring with a history of pre-term birth in the first pregnancy will be included in this study at their own will 4. Generalized Chronic Moderate to Severe Periodontitis as defined by AAP criteria (1999) 5. More than 20 teeth, excluding third molars

Exclusion criteria

Exclusion criteria: Exclusion criteria: Since the outcome of the study is dependent on presence of disease; obstetrical, medical and dental reasons for exclusion will be taken into account which included: A. Obstetrical reasons: Women with 1. Congenital uterine malformations, congenital vaginal malformations, fetal malformation, multifetal gestation and cervical incompetence, and/or any other known cause of premature labor. 2. Chronic diseases (severe anaemia, hepatic in sufficiency, diabetes, hypertension, epilepsy, cardiac disease, lung disease, epilepsy, renal disease, or a positive test for human immunodeficiency virus) or any cause that commands termination of pregnancy for fetal/maternal indication. 3. Poor dating or unknown dates will be excluded. 4. Iatrogenic prematurity 17 A. Medical reasons: Women with 1. History of infective endocarditis which could have required antibiotic prophylaxis preceding a PDL examination. 2. Congenital Heart Disease. 3. Chronic regimen of non-steroidal anti-inflammatory drugs (NSAIDs), Aspirin and chronic use of medications causing gingival enlargement. 4. Chronic smokers and alcoholics will be excluded. B. Dental reasons: Women with 1. Receipt of orthodontic treatment, dental prophylaxis, or periodontal dental treatment within the previous six months. 2. Extensive tooth decay 3. Presence of acute dental or periodontal disease or likely to have

Design outcomes

Primary

MeasureTime frame
Primary objective of the study: Comparative evaluation of incidence of adverse pregnancy outcomes between the study groups at Baseline, 1 month and 7-15 days post delivery Adverse pregnancy outcomes: 1. Preterm Birth (WHO Classification)- Extremely preterm (less than 28 weeks) Very preterm (28 to 32 weeks) Moderate preterm (32 to 34 weeks) Late preterm (34 to 37 weeks) 2. Low Birth Weight- Birth weight of less than 2500 g (as defined by WHO) Growth restriction (weight for gestational age)Timepoint: Baseline, 1 month and 7-15 days post delivery

Secondary

MeasureTime frame
Secondary objectives of the study: Comparative evaluation of systemic inflammation via selected inflammatory biomarker profile between the study groups. (Prostaglandin-E2 & Interleukin-6) Comparative evaluation of systemic inflammation via neutrophil-to-lymphocyte ratio (NLR) profile between the study groups Comparative evaluation of periodontal status via clinical parameters between the study groups. (Plaque index, Probing pocket depth, Clinical attachment level, Bleeding on probing).Timepoint: Baseline, 1 month & 7-15 days post delivery

Countries

India

Contacts

Public ContactDrVishakha Grover

Dr.Harvansh Singh Judge Institute of Dental Sciences

ajain.pu@gmail.com9888000444

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026