| CTRI Number |
CTRI/2024/01/062066 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of maternal oral health on new borns in pregnant patients. |
|
Scientific Title of Study
|
Effect of Early Periodontal Therapy on Pregnancy Outcomes- A Randomized Control 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 |
DrKirti Chaudhry |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Dentistry
All India Institute of Medical Sciences,
Jodhpur.
OPD 2A-211, Department of dentistry, AIIMS JODHPUR.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08003993889 |
| Fax |
|
| Email |
chaudhry_kirti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKirti Chaudhry |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Dentistry
All India Institute of Medical Sciences,
Jodhpur.
OPD 2A-211, Department of dentistry, AIIMS JODHPUR.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08003993889 |
| Fax |
|
| Email |
chaudhry_kirti@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKirti Chaudhry |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Dentistry
All India Institute of Medical Sciences,
Jodhpur.
OPD 2A-211, Department of dentistry, AIIMS JODHPUR.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08003993889 |
| Fax |
|
| Email |
chaudhry_kirti@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
New Delhi |
| 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 Kirti Chaudhry |
Room number 211. Department of Dentistry, All India Institute of Medical Sciences |
Basni Phase-II, Jodhpur
Jodhpur
RAJASTHAN |
8003993889
chaudhry_kirti@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early Periodontal Therapy |
Pregnant females would be given CPHC in the form of structured early periodontal therapy ( 10 weeks of gestation) . This includes Oral prophylaxis in the form of scaling and root planning. This may even require periodontal surgeries in few cases.
For maintaining periodontal health following oral hygiene measures would be advised.
1. Brushing twice a day.
2. Use dental floss once a day.
3. Use chlorhexidine mouthwash twice daily for15 days after the procedure, followed by a 15-day break, followed by a repeat treatment plan as prescribed by the specialist.
4. Use warm saline rinses two to three times each day.
|
| Comparator Agent |
No Active Intervention. |
The comparator arm in this study will include no active intervention except verbal oral hygiene instructions. Periodontal health assessment will be done at the time of enrolment and after delivery. Standard regular ANC visits will be done as per protocol. However, if these patients report any emergency dental problems, they would be given a standard of care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with confirmed pregnancy through UPT or through USG.
2. All pregnant female in age range of 18 to 35 years with a BMI of 18.5 to 24.9 with at least 20 teeth as a part of dentition would be included in the study.
|
|
| ExclusionCriteria |
| Details |
a. History of Frequent diagnosed UTI in preconception period (>3 episodes/year).
b. Diagnosed preconception chronic disease conditions like uncontrolled Diabetes, Hypertension, Thyroid Diseases, AIDS, and Chronic Liver and Renal diseases.
c. History of unexplained Preterm Labour, Preeclampsia, or stillbirth.
d. History of Diagnosed Autoimmune diseases (SLE, Rheumatoid Arthritis, Sjogren Syndrome, Ulcerative Colitis, Antiphospholipid Syndrome.)
e. Previous surgeries on the cervix.
f. Multifetal Gestation.
g. Contraindication to periodontal probing such as Congestive cardiac disease.
h. Medications that result in gingival overgrowth such as phenytoin, cyclosporin, and calcium channel blockers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The following outcome would be measured in both the groups:
1.Proportion of preterm births. |
Every 1-2 Months coinciding with ANC |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following outcomes would be measured in both the groups:
1. Mean birth weight of neonates.
2. Proportion of new born with Low birth weight.
3. Proportion of preeclampsia in pregnant female.
4. Proportion of IUGR seen during pregnancy
5. Periodontal health of the mother.
6. Any adverse outcomes
|
Every 1-2 Months coinciding with ANC |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [chaudhry_kirti@yahoo.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Periodontal diseases (PD)
are the most common chronic destructive inflammatory condition of supporting
structure of teeth initiated by oral microflora located in biofilms, plaque and
calculus1. Studies have shown access of periodontal pathogens to
fetoplacental unit through transient bacteraemia or by causing immunological
injury through metastatic inflammation or as a lipopolysaccharides reservoir.2
Research has advocated
periodontitis as an independent risk factor leading to various adverse
pregnancy outcomes (APOs) like IUGR, preterm labour and low-birth-weight(LBW)
babies.3,4,5Recent systematic and Cochrane review confirmed6
this with low level of evidence due to variation in time and regimen of
periodontal therapy and associated confounders demanding a well-designed
randomized control trial.
With very high PD prevalence and NHM statistics showing gruesome
maternal and child health scenario; maintaining good periodontal health can be low-hanging
fruit in reducing APOs. Already developed countries like Australia, USA,
Canada, Europe have included oral health care in ANCs (consensus-based
guidelines).
This study aims to draft
and implement the effect of specifically designed Comprehensive periodontal
health care (CPHC) including early structured periodontal therapy (>10 weeks
of gestation) and novel oral health maintenance program. Sustainability of this
novel oral health maintenance would be done through app-based nudging, using
focused group discussions and group mentoring in the intervention arm. Finally,
a log frame analysis would be used for improving the planning, implementing,
managing, monitoring and evaluating CPHC.
This study may open the
way for including CPHC as an integral part of the ANC regimen during pregnancy
to improve pregnancy outcomes. |