| CTRI Number |
CTRI/2024/02/062449 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
assessment of post cementation sensitivity of tooth with and without immediately sealing the dentin. |
|
Scientific Title of Study
|
Evaluation of post cementation sensitivity after immediate dentin sealing and cementation with bioactive luting cement-A SPLIT MOUTH 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 Varuni Karnam |
| Designation |
STUDENT |
| Affiliation |
Bapuji Dental College and Hospital, Davangere. |
| Address |
Post graduate student, Department of Prosthodontics and crown and bridge, Bapuji Dental college and Hospital, Davangere.
Davanagere
KARNATAKA
577004
India |
| Phone |
9483325517 |
| Fax |
|
| Email |
varunikarnam808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanya kumar B H |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Prosthodontics and crown and bridge, Bapuji Dental college and Hospital, Davangere.
Davanagere
KARNATAKA
577004
India |
| Phone |
9886000211 |
| Fax |
|
| Email |
budihal73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVaruni Karnam |
| Designation |
STUDENT |
| Affiliation |
Bapuji Dental College and Hospital, Davangere. |
| Address |
Post graduate student, Department of Prosthodontics and crown and bridge, Bapuji Dental college and Hospital, Davangere.
Davanagere
KARNATAKA
577004
India |
| Phone |
9483325517 |
| Fax |
|
| Email |
varunikarnam808@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| 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 Varuni karnam |
BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE. |
DEPARTMENT OF PROSTHODONTICS AND CROWN AND BRIDGE,BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE.
Davanagere
KARNATAKA |
9483325517
varunikarnam808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL REVIEW BOARD, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIOACTIVE LUTING CEMENT AND DENTIN BONDING AGENT |
Experimental group consists of 12 crowns which will be desensitized with dentin bonding agent using immediate dentin sealing technique and luted using bioactive luting cement and control group consists of 12 crowns which will be luted using bioactive luting cement. |
| Comparator Agent |
BIOACTIVE LUTING CEMENT AND DENTIN BONDING AGENT |
Experimental group consists of 12 crowns which will be desensitized with dentin bonding agent using immediate dentin sealing technique and luted using bioactive luting cement and control group consists of 12 crowns which will be luted using bioactive luting cement. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
• Patients in the age group of 21 to 45 years.
• Patients requiring full coverage crown and bridge prosthesis placement in relation
to maxillary and mandibular posterior teeth .
• Patients with satisfactory oral hygiene (Index- Simplified Oral Hygiene Index by
Greene and Vermilion- 1964).
• Abutment teeth and tooth receiving full coverage crown should be vital.
• Patients with absence of fresh post extraction wound or traumatic wound.
• Reliable and co-operative patients who are willing for the follow up |
|
| ExclusionCriteria |
| Details |
• Non- vital teeth.
• Restored teeth.
• Teeth with carious lesion.
• Teeth with attrition, abrasion, erosion, abfraction.
• Prominent periodontal pockets.
• Endodontic or periodontal infections.
• Subgingival caries.
• Patients with history of sensitivity in the abutment teeth.
• Patients with generalized dentinal sensitivity.
• Patients on radiation and immune suppressive therapy.
• Patients with bone associated diseases and malignant diseases.
• Patients having personal habits of alcohol, drug usage and smoking.
• Poor oral hygiene.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be significant difference in post cementation sensitivity between
bioactive luting cement with immediate dentin sealing(experimental) and
bioactive luting cement without immediate dentin sealing(control). |
1. Cold water test: The tooth will be irrigated with ice cold water for 5 seconds.
2. Compressed air test.
3. Biting pressure test.
Sensitivity evaluation:
Sensitivity will be evaluated with the help of Schiff Scale (0–3) which was given by Schiff.
Schiff Value chart Response of patient to stimulus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There will be significant difference in post cementation sensitivity between
bioactive luting cement with immediate dentin sealing(experimental) and
bioactive luting cement without immediate dentin sealing(control). |
1. Cold water test: The tooth will be irrigated with ice cold water for 5 seconds.
2. Compressed air test.
3. Biting pressure test.
Sensitivity evaluation:
Sensitivity will be evaluated with the help of Schiff Scale (0–3) which was given by Schiff.
Schiff Value chart Response of patient to stimulus |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
20/02/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
A total number of 12 patients will be selected with bilaterally posterior teeth missing. Experimental group consists of 12 crown or bridges which will be desensitized with dentin bonding agent using immediate dentin sealing technique and luted using bioactive luting cement and control group consists of 12 crown or bridges which will be luted using bioactive luting cement |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total number of 12 patients will be selected with identical bilaterally posterior teeth. Experimental group consists of 12 crown or bridges which will be desensitized with dentin bonding agent using immediate dentin sealing technique and luted using bioactive luting cement and control group consists of 12 crown or bridges which will be luted using bioactive luting cement. Standardization of tooth: Only vital maxillary or mandibular posterior teeth requiring fixed crown and bridge will be chosen . Standardization of Tooth Preparation: teeth will be prepared with equi-gingival finish line following standardized reduction protocol under the guidance of an experienced clinician. Standardization of crowns: Porcelain fused to Metal crowns will be luted. Clinical baseline data consisted of gingival index (GI). Post-cementation parameters were marginal integrity, discoloration of cement margin, post cementation sensitivity, retention and gingival inflammation. Marginal integrity, discoloration was measured clinically using a FDI criteria for clinical evaluation, post cementation sensitivity using Schiff scale and gingival inflammation using gingival inflammation index (GI). |