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CTRI Number  CTRI/2019/06/019949 [Registered on: 28/06/2019] Trial Registered Prospectively
Last Modified On: 10/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing dental sensitivity after restoring teeth with two novel dental materials 
Scientific Title of Study   Comparative Evaluation of Post Operative Sensitivity in Non Carious Cervical Lesions restored with Giomer and Nanoceramic composite Resin- 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 SURBHI GUPTA 
Designation  MDS 1st year student 
Affiliation  J.N Kapoor D.A.V Dental College 
Address  Girls hostel, J.N Kapoor D.A.V Dental college, Model Town,Yamunangar, Haryana
Department of Conservative Dentistry and Endodontics, J.N Kapoor D.A.V Dental College, Yamunagar
Yamunanagar
HARYANA
135001
India 
Phone  7500288400  
Fax    
Email  surbhi.gupta.svsu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR POONAM BOGRA 
Designation  SENIOR PROFESSOR AND GUIDE 
Affiliation  J.N KAPOOR D.A.V DENTAL COLLEGE 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODDONTICS, J.N KAPOOR D.A.V DENTAL COLLEGE, YAMUNANAGAR, HARYANA

Yamunanagar
HARYANA
135001
India 
Phone  9050462962  
Fax    
Email  poonambogra@yahoo.in  
 
Details of Contact Person
Public Query  
Name  DR POONAM BOGRA 
Designation  SENIOR PROFESSOR AND GUIDE 
Affiliation  J.N KAPOOR D.A.V DENTAL COLLEGE 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODDONTICS, J.N KAPOOR D.A.V DENTAL COLLEGE, YAMUNANAGAR, HARYANA

Yamunanagar
HARYANA
135001
India 
Phone  9050462962  
Fax    
Email  poonambogra@yahoo.in  
 
Source of Monetary or Material Support  
J.N Kapoor D.A.V Dental college, Model Town, Yamunanagr, Haryana 
 
Primary Sponsor  
Name  Dr Surbhi Gupta 
Address  Girls hostel , J.N Kapoor D.A.V Dental college, Model Town, Yamunanagar 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surbhi Gupta  J.N Kapoor D.A.V Dental college   DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, J.N KAPOOR D.A.V DENTAL COLLEGE, YAMUNANAGAR, HARYANA
Yamunanagar
HARYANA 		 7500288400

surbhi.gupta.svsu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non Carious Cervical Lesions in mandibular premolar teeth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Giomer  Giomer using self etch adhesive with self etch mode. Primer will be applied to the cavity surface for 10 seconds and cured for 5 seconds. Giomer will be applied into the cavity and each increment will be cured for 10 seconds . 
Intervention  GIOMER  Giomer using self etch dhesive system with selective enamel etching.Etching will be done for 15 seconds Primer will be applied to the cavity surface for 10 seconds and light cured for 5 seconds. Giomer will be applied into the cavity and each increment will be cured for 10 seconds each.  
Intervention  NANOCERAMIC COMPOSITE RESIN  Nanoceramic composite resin using Universal adhesive system with selective enamel etch mode. Etching will be done for 15 seconds. Adhesive application , curing and restoration will be done as already explained in above intervention 
Intervention  NANOCERAMIC COMPOSITE RESIN  Nanoceramic composite resin using Universal adhesive system with self etchh mode. Adhesive will be applied for 20 seconds Excess will removed for 5 seconds and light cured for 10 seconds. Composite will be applied into the cavity surface and each increment will be cured for 10 seconds.  
Comparator Agent  not applicable   not applicable 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients with at least 24 natural teeth
2. Patients having at least 2 contralateral teeth with non carious cervical lesions indicated for restoration
3. Depth of lesions being <1 mm and cervico- occlusal height <2mm
4. Patients willing to participate in study for 6 months
5. Patients with good oral hygiene
 
 
ExclusionCriteria 
Details  1. Carious teeth
2. Patients with history of spontaneous pain / sinus tract
3. Patients with class V lesions extending below cemento-enamel junction
4. Patients having parafunctional habits
5. Patients using any desensitizing toothpaste or mouthwash
6. Patients with active periodontal disease or those who have undergone periodontal surgery during last 6 months
7. Patient allergic to resin based materials
8. Asthmatic patients
9. Patients taking regular NSAIDS, psychotropic drugs or medications for other systemic diseases
10. Pregnant or lactating mothers
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients will be evaluated for presence or absence of post operative sensitivity after the defined recall period.  24 hours, 1 month, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Intensity of post operative sensitivity will serve as the secondary outcome for the study. Report from patient regarding dentinal hypersensitivity, air blast test and cold water will be recorded and scored according to Visual Analogue Scale(VAS scale).  24 hours, 1 month, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/07/2019 
Date of Study Completion (India) 15/04/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a randomized controlled clinical trial which will evaluate post operative sensitivity in Non Carious Cervical Lesions restored with Giomer using self etch adhesive and Nanoceramic composite resin using universal adhesive system with self etch and selective enamel etch mode. Mandibular premolars with non carious cervical lesions indicated for restorations will be selected according to the predefined inclusion and exclusion criteria. Sample size of 120 teeth will be selected for the study.They will be divided into 2 main groups A and B and then each group into 2 subgroups.Cavity preparation and restoration will be done. Patients will be kept on a recall period of 24 hours ,1 month,3 months and 6 months. Absence or presence of post operative sensitivity after the defined recall period will serve as the primary outcome of the study whereas intensity of post operative sensitivity will serve as the secondary outcome. 
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