| CTRI Number |
CTRI/2024/10/075418 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of potassium iodide added silver diamine flouride and silver fluoride in treatment of class 2 early childhood caries |
|
Scientific Title of Study
|
Comprehensive evaluation of potassium iodide added silver diamine fluoride and silver fluoride in stage-II Early childhood caries- A clinical 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 |
Revanuru Swathi |
| Designation |
PG Student |
| Affiliation |
K V G Dental college and hospital |
| Address |
Room no- 10
Department of pediatric and Preventive dentistry
KVG dental college and Hospital
Sullia DK
Kurunjibagh
Karnataka
India
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9620424264 |
| Fax |
|
| Email |
swathi.revanuru@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Krishnamoorthy S H |
| Designation |
Professor |
| Affiliation |
K V G Dental college and hospital |
| Address |
Room no- 10
Department of pediatric and Preventive dentistry
KVG dental college and Hospital
Sullia DK
Kurunjibagh
Karnataka
India
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9964428004 |
| Fax |
|
| Email |
kmoorthysh21@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Krishnamoorthy S H |
| Designation |
Professor |
| Affiliation |
K V G Dental college and hospital |
| Address |
Room no- 10
Department of pediatric and Preventive dentistry
KVG dental college and Hospital
Sullia DK
Kurunjibagh
Karnataka
India
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9964428004 |
| Fax |
|
| Email |
kmoorthysh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| K V G Dental college and hospital Sullia DK India Pincode 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Revanuru Swathi |
| Address |
Room No 10 Department of Pediatric and Preventive dentistry KVG Dental college and Hospital Sullia DK Karnataka India |
| Type of Sponsor |
Other [Self] |
|
|
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 Revanuru Swathi |
KVG Dental college and hospital |
Room No 10 Department of Pediatric and Preventive dentistry KVG Dental college and hospital Sullia Dakshina kannada Karnataka India 574327 Dakshina Kannada KARNATAKA |
9620424264
swathi.revanuru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KVG Dental college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Potassium iodide added Silver Diamine Fluoride |
A protective coating of petroleum jelly will be applied to the lip and mucosa and the affected area will be gently cleaned and dried with cotton gauze. Isolation of the affected area with the help of cotton rolls will be done followed by etching with 37% phosphoric acid. After 60secs the etched surface will be rinsed with water and dried. Then the etched surface is coated with 38% SDF over the carious surface with the help of a micro brush. Immediately followed by the application of KI using a separate micro brush until the precipitate changes from yellow to white and then clear. Applied area will be kept isolated for 2mins and then gently rinsed with water. This step is followed by GIC restoration. Clinical photographs and radiographs post procedure will be taken. Duration of the whole procedure will be 30mins |
| Intervention |
Potassium iodide added Silver fluoride |
A protective coating of petroleum jelly will be applied to the lip and mucosa and the affected area will be gently cleaned and dried with cotton gauze. Isolation of the affected area with the help of cotton rolls will be done followed by etching with 37% phosphoric acid. After 60secs the etched surface will be rinsed with water and dried. Then the etched surface is coated with 38% AgF with a microbrush. Immediately followed by the application of KI using a separate micro brush until the precipitate changes from yellow to white and then clear. Applied area will be kept isolated for 2mins and then gently rinsed with water. This step is followed by GIC restoration. Clinical photographs and radiographs post procedure will be taken. Duration of the whole procedure will be 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Active carious lesions which have ICDAS code 3 - 5.
Teeth selected as per ICCMS score 2 to 4.
Children who meet the Lampshire classification for cooperation.
Children with parental consent.
|
|
| ExclusionCriteria |
| Details |
Children with spontaneous pain or any signs of pulpal infection.
Children having any clinical or radiographic signs of periapical infection.
Active carious lesions which have ICDAS codes 5 and 6.
Children who have sensitivity to silver or other heavy metal ions.
Children with any gingival or perioral ulceration or stomatitis.
Children falling under ICCMS score other than 2 and 4.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To clinically evaluate and compare the tooth discoloration caused by 38% SDF added potassium iodide and 38% AgF added potassium iodide. |
Baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To clinically and radiographically evaluate and compare the caries progression with 38% SDF added potassium iodide and 38% AgF added potassium iodide.
To clinically evaluate and compare the duration of application of both the materials. |
Baseline, 6 months |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
01/02/2025 |
| 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="0" 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
|
Early Childhood Caries (ECC) is used to denote the occurrence of one or more primary teeth, in a child under the age of 6, that are decayed, restored, or missing. ECC has 4 stages, wherein any failure to address the initial reversible lesion will progress to the traumatic stage. In the traumatic stage of ECC, the teeth become so weak by caries that they fracture on minor trauma. Hence importance has to be given for the early reversal of the lesion and its arrest. ECC when left untreated results in pain, irritability, bacteremia, high treatment costs, reduced growth and development, speech disorders, and premature tooth loss with its sequelae of compromised chewing, loss of self-esteem, and permanent dentition hampering their mental attitude. 44% of children aged between 8 and 48 months have ECC in India. According to McDonald and Avery, the major three steps in preventing ECC are decreasing substrate concentration, decreasing microbial load, and increasing resistance of the tooth.6 Traditionally, the approach to managing carious lesions involves mechanical removal of the decayed tissue and replacing it with an appropriate restorative material. The treatment success with traditional approaches is highly influenced by the child’s behavior in the dental setting. As an alternative Minimal invasive dentistry (MID), which aims at maintenance of the sound tooth structure using non-invasive techniques has replaced the conventional procedures. Carol Anne et al, say that the “minimally invasive†approach to treating dental caries incorporates the dental science of detecting, diagnosing, intercepting, and treating dental caries on the microscopic level. ART, PRR, and SMART are among the many nonsurgical methods used in this approach to treating dental caries.SDF adheres to the philosophy of minimally invasive dentistry. Stebbins utilized SDF for the first time in 1969, and Japan approved it in August 2014 for therapeutic usage. SDF contains silver which is bactericidal and is used as an antimicrobial agent to arrest caries. It can be utilized extensively in pediatric dentistry since it is non-invasive, especially for children with unique healthcare needs and recalcitrant behavior, where traditional treatments can be technique-sensitive. It acts by obstructing dentinal tubules, promoting demineralized teeth to become more mineralized, and preventing the breakdown of dentinal collagen. The primary disadvantages of silver diamine therapy are the black stain left by the silver content and the strong taste and odor of ammonia, which also slightly irritates soft tissues. Studies were done on the effects of varying concentrations of silver diamine fluoride in arresting dental caries, but there is a dearth of information on how to prevent the tooth structure from discoloration after a procedure, cover up the smell, and lessen pain in the soft tissues. To prevent discoloration, our study applies potassium iodide (KI) after applying 38% silver fluoride with water as a solvent to overcome the soft tissue discomfort caused by ammonia. Thus this study aims to compare conventional 38% SDF added potassium iodide with 38% AgF added potassium iodide with water as a solvent. |