| CTRI Number |
CTRI/2024/07/071143 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Estimation of ingredients of saliva in children with mental problems before and after dental treatment |
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Scientific Title of Study
|
Estimation of Levels of Salivary Cytokines Interleukin-6 and Tumor Necrosis Factor-α in Children with Mild Intellectual Disability After Total Oral Rehabilitation- An In Vivo Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishani Baksi |
| Designation |
Postgraduate Student |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Room no 15, 4th floor, Department of Pediatric and Preventive Dentistry,AB Shetty Memorial Institute of Dental Sciences, Nithyanand nagar, Deralakatte, Mangaluru 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9800930633 |
| Fax |
|
| Email |
aishanibaksi23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aishani Baksi |
| Designation |
Postgraduate Student |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Room no 15, 4th floor, Department of Pediatric and Preventive Dentistry,AB Shetty Memorial Institute of Dental Sciences, Nithyanand nagar, Deralakatte, Mangaluru 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9800930633 |
| Fax |
|
| Email |
aishanibaksi23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishani Baksi |
| Designation |
Postgraduate Student |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Room no 15, 4th floor, Department of Pediatric and Preventive Dentistry,AB Shetty Memorial Institute of Dental Sciences, Nithyanand nagar, Deralakatte, Mangaluru 575018, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9800930633 |
| Fax |
|
| Email |
aishanibaksi23@gmail.com |
|
|
Source of Monetary or Material Support
|
| AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, Derlakatte, Mangaluru, Karnataka 575018, INDIA |
|
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Primary Sponsor
|
| Name |
Dr Aishani Baksi |
| Address |
Room no 15, 4th floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Nithyanand Nagar, Deralakatte, Mangalore 575018 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Suchetha Kumari |
CENTRAL RESEARCH LABORATORY |
3RD Floor, K.S HEGDE MEDICAL ACADEMY, P.O - NITYANANDANAGAR DERALAKATTE, MANGALORE - 575018, KARNATAKA, INDIA
Dakshina Kannada
KARNATAKA |
9448451318
kumarin@nitte.edu.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FULL MOUTH DENTAL TREATMENT |
BEFORE AND AFTER FULL MOUTH DENTAL TREATMENT |
| Intervention |
TOTAL ORAL REHABILITATION |
Total oral rehabilitation in children (including oral prophylaxis, pit and fissure sealants, fluoride application, atraumatic restorative treatment, pulp therapy, extractions) followed by diet counselling and reinforcement of oral hygiene instructions for the parents/care givers will be carried out. |
|
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children with mild intellectual disability between the age group of 3-6 years as specified by the DSM-5 classification given by the American Psychiatric association and having Intelligence Quotient in the range of 55-69.
Children with mild intellectual disability having early childhood caries.
Children whose parents are well motivated and have knowledge about intellectual disability and willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
Children with moderate, severe, profound and unspecified intellectual disability as specified by the DSM-5 classification given by the American Psychiatric association.
Children with Intelligence Quotient below 55, under anti-anxiety medication or with a history of seizures or with hearing and visual impairment
Medically compromised children and uncooperative children
Children whose parents are not willing to give their consent |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Effect of total oral rehabilitation on salivary cytokines |
Pre treatment, 1 month after treatment, 3 months after treatment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Oro-dental fluctuations following total oral rehabilitation and the possible link with alteration of salivary cytokine values |
Pre treatment, 1 month after treatment, 3 months after treatment |
|
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Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Children between the age group of 3-6 years of either gender with mild intellectual disability having Intelligence Quotient in the range of 55-69 as specified by DSM-5 classification given by American Psychiatric Association with early childhood caries will be considered for the study. Salivary samples will be collected from all the children for baseline data. Total oral rehabilitation in children (including oral prophylaxis, pit and fissure sealants, fluoride application, atraumatic restorative treatment, pulp therapy, extractions) followed by diet counselling and reinforcement of oral hygiene instructions for the parents/care givers will be carried out. Post treatment salivary samples will be collected from the children, 1 month and 3 months after total oral rehabilitation, diet counselling and reinforcement of oral hygiene instructions. Diet counselling
1.Interview will be conducted and diet diary will be introduced. Parent will be asked to maintain the diary and the amount, consistency and frequency of food consumed for the 6 consecutive days will be analyzed 2.Diet modification will be done based on the child’s preference which includes: a)Educate the parents about the nutritional value of the food b) Educating parents about the role of sugar in the decay process c)Emphasize the role of diet sugar rich foods like cookies, candies, sugar syrups etc in causing dental caries and limit their usage to mealtime only d)Emphasize the importance of unrefined foods like vegetable and fruits and their role in maintaining the overall nutritional and oral health status of the child e) Daily menu can be customized according to child’s needs, likes and preferences a) To reinforce the above measures b) To motivate the parents and child so as to maintain a healthy balanced diet 4.Oral hygiene instructions to parents which include: a) Analysis of the brushing technique b) providing knowledge about the importance of brushing twice a day c)teaching proper tooth brushing techniques, usage of fluoridated toothpastes, mouthwashes, floss and other at home practices to maintain oral hygiene. 1)Collection of salivary samples-
The participating children will be asked to refrain from eating and drinking for at least 1 hour prior to saliva collection. The participating children will be made to sit quietly with the head bent down (Coachman position) and the mouth open to allow the saliva to drip passively from the lower lip into the sterile plastic container. For uncooperative children, saliva collection will be done by micro-pipetting method, using needleless syringes to collect unstimulated saliva or by cotton swab method. 2 ml of unstimulated saliva samples will be collected from the participating children early in the morning (9-11am) in a sterile container, which will be placed in a storage box at a temperature of 40 Celsius. 12 Saliva samples will be transported to Central Research Laboratory KSHEMA. Each sample must be frozen, thawed and centrifuged at least once in order to separate the mucins by centrifugation and stored in an ultra-cold storage unit at -800 Celsius until further usage.12 The samples will then be subjected to solid phase enzyme-linked immunosorbent assay (ELISA) for salivary interleukin-6 & Tumor Necrosis Factor-α level Evaluation of salivary interleukin-6
3)Evaluation of salivary Tumor Necrosis Factor-α will be done by: 8) METHOD OF STATISTICAL ANALYSIS: Data will be statistically analyzed using Shapiro Wilk test and paired t test/Wilcoxon Signed Rank Test. p value <0.05 will be considered statistically significant. Statistical software SPSS version 20 will be used to analyse the data.
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