| CTRI Number |
CTRI/2024/02/063350 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the success rate of two recent dental cements filled in decayed teeth of 4-8 year old children. |
|
Scientific Title of Study
|
Evaluation of clinical performance of carious primary molars restored with two bioactive restorative materials in 4-8 year old children |
| 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 Gontla Devi Saranya |
| Designation |
Postgraduate student |
| Affiliation |
Vishnu Dental Collage |
| Address |
Department of Pedodontics and Preventive Dentistry
block 3, room no 5, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7981129547 |
| Fax |
|
| Email |
saranya1999saru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr chaitanya penmatsa |
| Designation |
Professor |
| Affiliation |
Vishnu Dental Collage |
| Address |
Department of Pedodontics and Preventive Dentistry
block 3, room no 5, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9908217142 |
| Fax |
|
| Email |
chaitanyap@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr chaitanya penmatsa |
| Designation |
Professor |
| Affiliation |
Vishnu Dental Collage |
| Address |
Department of Pedodontics and Preventive Dentistry
block 3, room no 5, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9908217142 |
| Fax |
|
| Email |
chaitanyap@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental Collage,Vishnupur, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Dr Gontla Devi Saranya |
| Address |
Vishnu Dental Collage,Vishnupur, Bhimavaram |
| 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 Gontla Devi Saranya |
VISHNU DENTAL COLLEGE |
Department of Pedodontics and Preventive Dentistry
block 3, room no 5, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH |
7981129547
saranya1999saru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Restoration with Activa (Pulpdent) |
Activa is a glass ionomer cement enriched with bioglass and was proven to have superior physical properties, strength, esthetics and greater release of calcium, phosphate and fluoride ions than glass ionomer cement. It possess all the advantages of GIC in a strong and flexible resin matrix.Caries excavation will be done using high speed airotor hand piece and BR-45 round bur.Isolation will be done using cotton rolls and high volume suction device.Acid Etching for 15 seconds will be carried out with 37% phosphoric acid then rinsed with water for a minute and then dried. Application of bonding agent will be done and light cured for 20 seconds. The cavity will be restored with Active bioactive material using an automated syringe and allowed to self-cure for 2 min, followed by light curing for 20 seconds. .Post- operative occlusal evaluation will be done using Articulating paper.Final adjustments will be made if required using finishing bur (EX-21EF).Follow-up will be done at 6 and 12 months.Evaluation criteria: (Modified USPHS criteria) Marginal adaptation, Surface roughness, Secondary caries, Marginal staining. |
| Intervention |
Restoration with Cention N (ivoclar vivadent) |
Cention N is a Bioactive, resin based tooth coloured direct restorative material with high flexural strength and belongs to Alkasite group, a subgroup of composite. It has alkaline fillers embedded in methacrylate resin matrix and releases hydroxyl ions that neutralize the activity of acidogenic cariogenic bacteria.Caries excavation will be done using high speed airotor hand piece and BR-45 round bur.Isolation will be done using cotton rolls and high volume suction device.The powder and liquid provided with Cention N material will be mixed according to the manufacturer instructions using plastic spatula.The cavity will be restored with the material and light cured for 20seconds.Post- operative occlusal evaluation will be done using Articulating paper.Final adjustments will be made if required using finishing bur (EX-21EF).Follow-up will be done at 6 and 12 months.Evaluation criteria: (Modified USPHS criteria) Marginal adaptation, Surface roughness, Secondary caries, Marginal staining.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary molars with bilateral occlusal caries in
2. 4-8 year old children(ICDAS score 4/5 )
3. Co-operative children.
4. Children who are willing to be a part of the
study.
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients.
2. Teeth with developmental defects.
3. Teeth that are un-restorable
4. Teeth with signs and symptoms of pain or swelling
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Marginal adaptation, Surface roughness, Secondary caries and Marginal staining |
At 6 and 12 months after the restoration is done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="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 composites have been traditionally used aesthetic restorative materials. However secondary caries beneath and around the restorative materials is the most common cause of failure of composite resin restorations. The majority of the available composite resins have no remineralizing effect. In order to overcome these disadvantages of composite resins, there is a increasing tendency to use resin based bioactive and remineralizing restorative materials to increase the durability of bonded restorations. In restorative dentistry, the term bioactive usually refers to the ability of a material to form hydroxyapatite crystals on its surface. Bioactive materials are moisture friendly and imitate nature and participate in dynamic ionic exchange. Release of different remineralizing ions from the restorative materials into oral cavity and at the tooth restoration interface improves the longevity of restoration and decreases the rate of recurrent caries. Screening of 4-8 year old patients attending the outpatient department will be done. Details of the study will be explained to the patients and parents, with written informed consent obtained. Considering inclusion and exclusion criteria, children with bilateral occlusal caries will be included and random allocation in to two groups will be done with split mouth design. Group 1 will be restored with cention n and group 2 will be restored with active bioactive restorative materials. Post operative occlusal evaluation will be done using articulating paper and final adjustments will be done if required with finishing burs. Follow-up will be done at 6 and 12 months intervals and marginal adaptation, surface roughness, secondary caries and marginal staining will be evaluated using modified USPHS criteria. Statistical analysis will be done using non parametric tests, inter groupe comparison will be done using Mann Whitney ‘’ U’’ test and intragroup comparison will be done at 6 and 12 months intervals using Wilcoxon sign rank test . |