| CTRI Number |
CTRI/2025/01/079101 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Other (Specify) [Nutritional Supplementation] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The Impact of Scaling, Deep Cleaning, and Nutritional Supplementation on Adverse Pregnancy Outcomes, Placental Infection Prevention, and Gum Health Improvement in Pregnant Women |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arpit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room No. 215, First Floor, Oral Health Sciences Centre, Division of Public Health Dentistry, PGIMER, Sector 12, Chandigarh, India-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room No. 215, First Floor, Oral Health Sciences Centre, Division of Public Health Dentistry, PGIMER, Sector 12, Chandigarh, India-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room No. 215, First Floor, Oral Health Sciences Centre, Division of Public Health Dentistry, PGIMER, Sector 12, Chandigarh, India-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Science and Engineering Research Board (SERB),
3rd and 4th Floor, Block II, Technology Bhawan, New Mehrauli Road, New Delhi, India-110016 |
|
|
Primary Sponsor
|
| Name |
Science and Engineering Research Board |
| Address |
3rd and 4th Floor Block II
Technology Bhawan,
New Mehrauli Road,
New Delhi -110016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arpit Gupta |
Post Graduate Institute of Medical Education & Research |
Room No. 205, Preventive Clinic, Oral Health Sciences Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8826674284
arpitg.in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
OHI |
Oral Hygiene Instructions (OHI) alone (positive control).
All participants will receive a 15-minute oral health session at baseline, including verbal, visual, and written instructions on oral hygiene practices (tooth brushing, flossing, using interdental brushes, cleaning dentures, plaque disclosing, and mouthwash). Follow-ups will occur at T0, T1, T2, and Td
where, T0: Baseline (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. |
| Intervention |
OHI + Nutritional Supplementation |
OHI + nutritional supplementation with 650mg omega-3 fatty acids capsules.
All participants will receive a 15-minute oral health session at baseline, including verbal, visual, and written instructions on oral hygiene practices (tooth brushing, flossing, using interdental brushes, cleaning dentures, plaque disclosing, and mouthwash). Follow-ups will occur at T0, T1, T2, and Td
where, T0: Baseline (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.
Each patient will receive a 650 mg Omega-3 capsule daily at bedtime from enrolment until delivery.
Follow-ups will occur at T0, T1, T2, and Td
where, T0:Baseline (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. |
| Intervention |
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, visual, and written instructions on oral hygiene practices (tooth brushing, flossing, using interdental brushes, cleaning dentures, plaque disclosing, and mouthwash). Follow-ups will occur at T0, T1, T2, and Td
where, T0: Baseline (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.
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 days.
Follow-ups will occur at T0, T1, T2, and Td
where, T0: Baseline (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. |
| Intervention |
OHI+ NSPT+ Nutritional Supplementation |
OHI + NSPT + nutritional supplementation with 650mg omega-3 fatty acids capsules.
All participants will receive a 15-minute oral health session at baseline, including verbal, visual, and written instructions on oral hygiene practices (tooth brushing, flossing, using interdental brushes, cleaning dentures, plaque disclosing, and mouthwash). Follow-ups will occur at T0, T1, T2, and Td
where, T0: Baseline (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.
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 days. Follow-ups will occur at T0, T1, T2, and Td
where, T0: Baseline (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.
Each patient will receive a 650 mg Omega-3 capsule daily at bedtime from enrolment until delivery.
Follow-ups will occur at T0, T1, T2, and Td
where, T0: Baseline (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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcomes that will be measured are preterm birth and low birth weight. |
Follow-up of all 280 participants will be done at timepoint Td (At the time of delivery ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
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 |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recent systematic reviews have suggested that individuals with chronic periodontitis should be counselled to include omega-3 fatty acids in their diet in addition to receiving standard periodontal therapy. Although research has shown that use of omega-3 fatty acid as an adjunct to NSPT is effective in improving periodontal outcomes, there is lack of evidence about the same among pregnant women, who are at high risk of suffering from adverse effects of poor periodontal health. Objectives: To assess and compare the additional benefit of non-surgical periodontal therapy (NSPT) versus omega-3-fatty acids nutritional therapy (NT) alone on the incidence of preterm births (less than 37 weeks of gestation) and low-birthweight (less than 2.5 Kgs) as well as the change in oral & fetoplacental microbiome, pro-inflammatory biomarkers in blood/ saliva and the periodontal health status. Methodology: Pregnant women fulfilling the eligibility criteria will be enrolled in this randomized controlled clinical trial. The study participants will be randomly allocated to one of the four intervention groups. Group 1 participants will receive Oral Hygiene Instructions (OHI) + NSPT, Group 2 subjects will receive OHI + NSPT + nutritional supplementation with 650g omega-3 fatty acids capsules, Group 3 will receive OHI + nutritional supplementation with 650g omega-3 fatty acids capsules while Group 4 participants will receive OHI alone. Periodontal health will be assessed using OHI-S, GR, PD and BOP dental indices, pro-inflammatory biomarkers in the saliva and blood as well as the microbiome assessment of saliva, placenta and dental plaque samples. The outcome parameters will be assessed at baseline, at 28-32 weeks of gestation and once at the first visit of the participant post-delivery. Level of significance will be set at a p-value less than 0.05. Expected Outcomes: The combined effect of NSPT and nutritional supplements using omega-3 fatty acids is expected to be an effective strategy in significantly reducing the incidence of preterm births and low birth weight. |