| CTRI Number |
CTRI/2025/06/089809 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of three different Restorative Materials in Primary Molars |
|
Scientific Title of Study
|
Clinical and radiographic evaluation of conventional glass ionomer cement, flowable resin reinforced glass ionomer cement and self-adhesive fluoride releasing composite restorations in primary molars: a comparative randomized 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 |
Dr Mahesh Dadpe |
| Designation |
Head Of The Department |
| Affiliation |
MIDSR DC, Latur |
| Address |
Room no.6, Pediatric and preventive dentistry,
MIDSR DC,
Ambejogai Road, latur
pin:413512
Latur MAHARASHTRA 413512 India |
| Phone |
9823733222 |
| Fax |
|
| Email |
drmaheshdadpe@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vaidehi Domale |
| Designation |
Post Graduate Student |
| Affiliation |
MIDSR Dental College, Latur, Maharashtra |
| Address |
Room no.6, ground floor, Department of Pediatric and Preventive Dentistry,
MIDSR Dental College,
Latur.
Latur MAHARASHTRA 413512 India |
| Phone |
9309979718 |
| Fax |
|
| Email |
domalevaidehi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mahesh Dadpe |
| Designation |
Head Of The Department |
| Affiliation |
MIDSR DC, Latur |
| Address |
Room no.6, Pediatric and preventive dentistry,
MIDSR DC,
Ambejogai Road, latur
pin:413512
Latur MAHARASHTRA 413512 India |
| Phone |
9823733222 |
| Fax |
|
| Email |
drmaheshdadpe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 6
Department Of Pediatric And Preventive Dentistry
MIDSR Dental College, Latur
Pin: 413512 |
|
|
Primary Sponsor
|
| Name |
Vaidehi Domale |
| Address |
Room No. 6
Department Of Pediatric And Preventive Dentistry
MIDSR Dental College, Latur
Pin: 413512 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mahesh Dadpe |
Room No. 6
Department Of Pediatric And Preventive Dentistry
MIDSR Dental College, Latur
Pin: 413512 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahesh Dadpe |
MIDSR Dental College |
Room No. 6, Ground floor,
Department Of Pediatric And Preventive Dentistry Latur MAHARASHTRA |
9823733222
drmaheshdadpe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MIDSR,Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children in need with restoration of primary teeth. |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional glass ionomer cement (GC Fuji IX) |
Anatomic form, Secondary caries, Marginal discoloration, Marginal adaptation/ integrity, Post-operative sensitivity after 3 month, 6 month, 12 month |
| Intervention |
Light cure flowable glass ionomer cement Kids-e-Restore and Self-adhesive fluoride releasing composite Surefil one |
Anatomic form, Secondary caries, Marginal discoloration, Marginal adaptation/ integrity, Post-operative sensitivity after 3 month, 6 month, 12 month |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Aged 3-8 years
International caries detection and assessment system ICDAS score ranging from 3–5
Frankel’s Behaviour rating scale score of 3 or 4 |
|
| ExclusionCriteria |
| Details |
Primary molars with deep carious lesion
Presence of any pulpal disease with or without pain
Primary molars with developmental defects
History of allergy to any material being used
History of abnormal parafunctional activity
Participant with mental disability and systemic illness |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluate and compare clinical and radiographical efficacy of light cure flowable resin reinforced glass ionomer cement, self-adhesive fluoride releasing composite and conventional glass ionomer cement when used as a restorative material in primary molars |
3 month, 6 month,12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluate and compare clinical and radiographical efficacy of self-adhesive fluoride releasing composite, light cure flowable resin reinforced glass ionomer cement and conventional glass ionomer cement when used as a restorative material in primary molars. |
3 month, 6 month,12 month |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="1" Months="0" 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
|
Dental caries is a
multifactorial, dynamic, diet-modulated, biofilm-mediated disease that causes a
net mineral loss in the tooth hard tissues. It is regarded as a serious public
health issue and is the most prevalent noncommunicable disease in the world.
Approximately 530 million children worldwide suffer from caries in their
primary teeth, compared to an estimated 2.3 billion adults with caries in their
permanent teeth. Caries management
in children requires careful selection of restorative material with
restorations lasting until teeth exfoliates. While for decades amalgam has been
preferred due to moisture tolerance, ease of placement, and low cost. However, its use has been declined due to poor
aesthetics and detrimental health effects caused by mercury release. However, Glass ionomer cement (GIC) is the
most commonly used amalgam substitute. As it has the advantages of chemically
adhesion to tooth structure, highly biocompatible and releases fluoride over
time to provide a cariostatic effect. On the other hand, it has poor wear
resistance, a slow setting rate, low fracture toughness, susceptibility to
moisture contamination and dehydration during the initial setting phase. To overcome this, an
interesting advancement was introduced High-viscosity glass-ionomer (HVGI),
marketed under the trade name of Kids-e-Restore, which is self-adhesive,
light-cured, flowable, and ready to use resin-reinforced glass ionomer restorative
material. It promotes antimicrobial and anticaries activity by releasing
fluoride and its self-adhesive technology eliminates
the need for etching and bonding processes with chemical adhesion. Although, one of the most common
restorative materials for primary tooth restorations is composite resin, which
outperforms GICs in terms of aesthetics, wear resistance, and fracture
resistance. Even though, composite resins do not release fluoride and exhibit
polymerization shrinkage after setting, which can result in postoperative
sensitivity, marginal discoloration, and secondary caries. Therefore, dentists
need an alternative to composite or GICs which is affordable, releases
fluoride, simple to use, and has
acceptable strength and aesthetics. However, in recent introduction
of a novel restorative material, known as Surefil one (Dual-cured composites), which
is a self-adhesive fluoride-releasing composite, has been introduced to enable
the easy application of bulk-fill composites up to 4-5 mm thick. Additionally, self-adhesive
composites have been created by adding acidic moieties to reactive diluents so
they will adhere to dentin and enamel. This Dual-cured composites consist of two initiator
systems with light-cured and chemical-cured components. The initiator
polymerizes top layers and initial hardening with light-cured reaction, while
deeper layers are polymerized through a slow chemical-cured reaction. These
composites have higher conversion values compared to light-cured bulk-fill and
conventional composites, indicating better mechanical properties and
degradation resistance. Surefil one
(Dual-cured bulk-fill materials) is used for direct restorations in a posterior-stress-bearing
areas, requiring no capping, and different loads. In literature there are no in-vivo studies available
comparing the clinical and radiographic efficiency of light cure flowable resin
reinforced glass ionomer cement, self-adhesive fluoride-releasing composites
and conventional glass ionomer cement in primary molars. |