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CTRI Number  CTRI/2024/11/076267 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Non-surgical Periodontal Therapy during Pregnancy and Risk of Adverse Pregnancy Outcomes 
Scientific Title of Study   Effect of Non-surgical Periodontal Therapy on Risk of Adverse Pregnancy Outcomes: A Randomized Controlled Trial in Uttarakhand Population.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1307-8014  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aaron F Gomes 
Designation  Professor and Head, Deptt of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute  
Address  Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone  9860597402  
Fax    
Email  aarongomes@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aaron F Gomes 
Designation  Professor and Head, Deptt of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute  
Address  Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone  9860597402  
Fax    
Email  aarongomes@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Aaron F Gomes 
Designation  Professor and Head, Deptt of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute  
Address  Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone  9860597402  
Fax    
Email  aarongomes@hotmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. Dehradun, Uttarakhand. 
 
Primary Sponsor  
Name  Aaron F Gomes 
Address  Professor and Head, Deptt of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aaron F Gomes  Uttaranchal Dental and Medical Research Institute   Deptt of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140
Dehradun
UTTARANCHAL 		 9860597402

aarongomes@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttaranchal Dental and Medical Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified, (2) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  A cohort of pregnant women in Uttarakhand State of India, will be studied from baseline of 16 weeks of gestational age till parturition. They will be evaluated for scores of periodontal disease and at end of pregnancy for scores of pregnancy outcomes like gestational age at delivery, birth weight of neonate, and any complications of pregnancy. Normal ante-natal care will be performed for all participants. No dental intervention will be done except for oral hygiene instructions. 
Intervention  Test Group 1 (Non surgical Periodontal Therapy once during pregnancy)  Non-surgical periodontal therapy including scaling and polishing will be performed once at gestational age of 16-20 weeks in a cohort of pregnant women in Uttarakhand State of India. The non-surgical periodontal therapy will consist or oral hygiene instruction and a single sitting of scaling and polishing of about 30minutes. These patients will be studied from baseline of 16 weeks of gestational age till parturition. They will be evaluated for scores of periodontal disease and at end of pregnancy for scores of pregnancy outcomes like gestational age at delivery, birth weight of neonate, and any complications of pregnancy. Normal ante-natal care will be performed for all participants. 
Intervention  Test Group II (Non surgical Periodontal Therapy twice during pregnancy)  Non-surgical periodontal therapy including scaling and polishing will be performed at gestational age of 16-20 weeks who received non-surgical periodontal therapy performed at gestational age of 16-20 weeks, to be followed by a repeat of non-surgical periodontal therapy and will be performed at gestational age of 25-28 weeks,in a cohort of pregnant women in Uttarakhand State of India. Each of both episodes of non-surgical periodontal therapy will consist or oral hygiene instruction and a single sitting of scaling and polishing of about 30minutes.These patients will be studied from baseline of 16 weeks of gestational age till parturition. They will be evaluated for scores of periodontal disease and at end of pregnancy for scores of pregnancy outcomes like gestational age at delivery, birth weight of neonate, and any complications of pregnancy. Normal ante-natal care will be performed for all participants. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  The study population will consist of pregnant women screened from amongst patients who will visit the Department of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, Dehradun, Uttarakhand, and those who will be presenting for routine antenatal care to the Department of Obstetrics and Gynecology, Uttaranchal Hospital, a unit of Uttarancha Dental and Medical research Institute, Mazri Grant, Dehradun, Uttarakhand.
- healthy pregnant women
- age 18 to 40 years;
- single gestation at ≤16 weeks;
- subjects with at least 20 completely erupted teeth, excluding the third molars;
- willing to participate in study
 
 
ExclusionCriteria 
Details  - multiple gestation;
- previous preterm low birth weight;
- more than 1 previous miscarriage or one greater than 18 weeks;
- history of uncontrolled diabetes; hypertension; alcoholism; drug abuse;
- history of human immunodeficiency virus (HIV) infection; heart disease, kidney disease or liver disease; recurrent cystitis; viral infections; venereal infections; toxoplasmosis;
- history of current use of tobacco (smoking/smokeless) or alcohol;
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Adverse pregnancy outcome namely low birth weight
pre term birth
pre term low birth weight
pre eclampsia
APGAR score
 		 16 weeks to term of the pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
Silness and Löe plaque index
Löe and Silness Gingival index
Lang et al Bleeding on probing index
Pocket probing depth
clinical attachment level 		 t1 between 16 to 20 weeks of pregnancy
t2 between 21 to 24 weeks of pregnancy
t3 between 29 to 32 weeks of pregnancy 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2024 
Date of Study Completion (India) 22/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aarongomes@hotmail.com].

  6. For how long will this data be available start date provided 01-10-2026 and end date provided 31-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Background: Chronic disease like periodontitis in the expectant mother are believed to have an association with the occurrence of adverse pregnancy outcomes (APOs) like low birth weight (LBW), preterm birth (PTB), preterm low birth weight (PLBW), pre-eclampsia and stillbirth. The present study aimed to investigate the association between periodontal disease and APOs in north Indian population

Null hypothesis: There is no association between the periodontal health status and adverse pregnancy outcome.

Material and Methods:  Participants who fulfilled the inclusion criteria will be randomly divided into three study groups: (i) Control group: No non-surgical periodontal therapy during pregnancy, only oral hygiene instructions. (ii) Test group 1: pregnant women will receive non-surgical periodontal therapy at 16-20 weeks of gestational age and (iii) Test group 2: Pregnant women will receive non-surgical periodontal therapy once at 16-20 weeks of gestation followed by a repeat of non-surgical therapy at 25-28 weeks of gestation. The obstetric parameters will be recorded after delivery and will be expressed in terms of frequency and percentage. The following periodontal parameters will be measured: Plaque Index, Gingival Index, bleeding on probing, pocket probing depth, clinical attachment levels, teeth present and periodontal case definition. These will be measured at 16-20 weeks of gestation (time-point t1), 21-24 weeks of gestation (time-point t2) and 29-32 weeks of gestation (time-point t3). Data analysis will be performed using ANOVA with Bonferroni correction, paired t-test between groups and a p-value of ≤0.05 will be considered statistically significant. Pearson’s Chi Square test will be performed to determine measure of association between APOs and periodontal health/disease and the Cramér’s V Test evaluated the strength of this association.

 
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