| CTRI Number |
CTRI/2018/09/015814 [Registered on: 24/09/2018] Trial Registered Prospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the use of adhesives in class V dental restorations done using a new alkasite dental cement - Cention N. |
|
Scientific Title of Study
|
A RANDOMIZED DOUBLE-BLIND ACTIVE CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFECT OF USE OF ADHESIVES ON THE CLINICAL OUTCOME IN CLASS V RESTORATIONS USING CENTION N , A DIRECT FILLING ALKASITE MATERIAL & PACKABLE GLASS IONOMER CEMENT IN CHILDREN AND YOUNG ADULTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HIMANSHU AERAN |
| Designation |
DIRECTOR PRINCIPAL |
| Affiliation |
SEEMA DENTAL COLLEGE & HOSPITAL |
| Address |
SEEMA DENTAL COLLEGE & HOSPITAL
PASHULOK RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09837063005 |
| Fax |
|
| Email |
drhimanu4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PREETI DHAWAN |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
SEEMA DENTAL COLLEGE & HOSPITAL |
| Address |
DEPARTMENT OF PEDODONTICS & PREVENTIVE DENTISTRY
SEEMA DENTAL COLLEGE & HOSPITAL RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
08937815218 |
| Fax |
|
| Email |
preetidhawan10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ADITI SINGH |
| Designation |
ASST. PROFESSOR |
| Affiliation |
SEEMA DENTAL COLLEGE & HOSPITAL |
| Address |
DEPARTMENT OF PEDODONTICS & PREVENTIVE DENTISTRY
SEEMA DENTAL COLLEGE & HOSPITAL RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
08279819316 |
| Fax |
|
| Email |
draditisingh7@gmail.com |
|
|
Source of Monetary or Material Support
|
| SEEMA DENTAL COLLEGE & HOSPITAL
PASHULOK RISHIKESH
PIN- 249203 |
|
|
Primary Sponsor
|
| Name |
DR HIMANSHU AERAN |
| Address |
SEEMA DENTAL COLLEGE & HOSPITAL
PASHULOK RISHIKESH
PIN- 249203 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR ADITI SINGH |
SEEMA DENTAL COLLEGE & HOSPITAL PASHULOK RISHIKESH |
| DR PREETI DHAWAN |
SEEMA DENTAL COLLEGE & HOSPITAL PASHULOK RISHIKESH |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR HIMANSHU AERAN |
SEEMA DENTAL COLLEGE & HOSPITAL |
Room no 4 , THIRD FLOOR SEEMA DENTAL COLLEGE & HOSPITAL PASHULOK RISHIKESH
PIN 249203
Dehradun
UTTARANCHAL |
09837063005
drhimanu4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee _ Seema Dental College & Hospital Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A NEW ALKASITE DENTAL CEMENT |
A NEW ALKASITE DENTAL CEMENT BY TRADE NAME OF CENTION-N.
Amount : that will be required to fill class V cavity (dimensions :a box-shaped class V cavity with the dimensions of approximately upto 3.0 mm (mesiodistal), approximately upto 3.0 mm (occluso-gingival), and approximately upto 1.5 mm depth at the occlusal margin and approximately upto 0.75 mm depth at the cervical margin in the buccal surface in an individual to be evaluated for a period of upto 2 years |
| Comparator Agent |
PACKABLE TYPE IX GLASS IONOMER CEMENT |
RESTORATIVE GLASS IONOMER CEMENT BY TRADE NAME-GC FUJI IX
Amount : that will be required to fill class V cavity (dimensions :a box-shaped class V cavity with the dimensions of approximately upto 3.0 mm (mesiodistal), approximately upto 3.0 mm (occluso-gingival), and approximately upto 1.5 mm depth at the occlusal margin and approximately upto 0.75 mm depth at the cervical margin in the buccal surface in an individual to be evaluated for a period of upto 2 years |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1) 5-14 year old individual (both males and females) of districts of Uttarakhand.
2) Participants who have bilateral class V cavities in anterior teeth/premolars in primary/mixed /permanent dentition.
3) Individuals with a no systemic illness or psychological disorder of any kind
4) Individuals who do not have any removable appliance where the teeth in concern act as abutment tooth.
5) Individuals who do not have any malocclusion or TMJ related disorder.
6) The teeth in question should be periodontally sound and without any pulpal pathology.
7) Individuals who fulfill the research criteria and are ready to give the consent to participate in the study are considered for the study.
|
|
| ExclusionCriteria |
| Details |
1) Children below the age of 5years and above the age of 14 years.
2) Participants who refuse to participate in the study.
3) Subjects who are uncooperative for clinical examination during the study.
4) Subjects with any type of severe systemic disease or hypoplastic teeth or with persistent faulty oral habits.
5) Individuals with periodontally compromised teeth or pulpally involved anterior teeth / premolars.
6) Individuals with missing posterior teeth or malocclusion or TMJ disorder.
7) Individuals who can’t comply for a follow up of upto 2 years.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| dentinal hypersensitivity shall be checked using Visual Analog Scale with the help of air blast using a three way syringe and tactile sensitivity shall be checked using 17/23 explorer repeated three times before recording. |
0,6months,12months,18months,24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| retention, marginal adaptation, anatomic form, surface texture and secondary caries |
0,6months,12months,18months,24 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/10/2018 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Traditionally resin based glass ionomer cements and advanced composites are used to treat non carious cervical lesions. Composites have an innate drawback of no ionic release and hence risk of secondary carious involvement. So Cention N could emerge as a good clinical option to treat such lesions.There is no evidence based update on Cention N so far. So a randomized clinical trial to evaluate the clinical outcome of this new material as a viable anterior esthetic material is undertaken to evaluate the use of Adhesives on the clinical outcome i.e retention, marginal adaptation anatomic forms surface texture and secondary caries in class v restorations using cention N as a direct filling material in children and young adults and to evaluate post-operative sensitivity in class V restorations using Cention N a direct filling material in the same individuals. A total sample of approximately 32 individuals belonging to age group of 5-14 year old reporting to Seema Dental College and Hospital having bilateral carious class V cavities shall be selected based on the inclusion and exclusion criteria. Of the 32 individuals two sub groups ie. Test and control group shall be made each containing 16 individuals. In the test group every individual shall be subjected to split mouth technique where Cention N with adhesive shall be used to restore the tooth on right side and without adhesive on left side.. Type IX GIC shall be used for control group.
| The sensitivity shall now be recorded using Visual Analog Scale with the help of air blast using a three way syringe and tactile sensitivity shall be checked using 17/23 explorer repeated three times before recording.The patients shall be given post-operative instructions and recalled after a period of 6 months interval for up to two years to evaluate the restorations using the USPHS- Ryge criteria for retention, marginal adaptation, anatomic form, surface texture and secondary caries. | |