| CTRI Number |
CTRI/2024/05/067871 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparision of Protooth Cement and Biodentine in Indirect Pulp capping in Children. |
|
Scientific Title of Study
|
Comparative evaluation of clinical and radiographic outcomes of indirect pulp capping using protooth cement and biodentine in carious primary molars- An in-vivo study. |
| 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 N Devi Vyshnavi |
| Designation |
Postgraduate Student |
| Affiliation |
Sri Sai College of Dental Surgery |
| Address |
Room number 9,
Department of Pedodontics,
Sri Sai College Of Dental Surgery,
1-2-64/1&2,Kothrepally,
Opp. Shiv Sagar lake, Vikarabad,
Telangana 501102.
Hyderabad
TELANGANA
501102
India |
| Phone |
08904268032 |
| Fax |
|
| Email |
ndvyshnavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CH Sampath Reddy |
| Designation |
Head Of The Department |
| Affiliation |
Sri Sai College Of Dental Surgery |
| Address |
Department of pedodontics and preventive Dentistry ,SRI SAI COLLEGE OF DENTAL SURGERY, 1-2-64/1&2 , Kothrepally, opp. Shiv Sagar lake, Vikarabad, Telangana 501102.
Hyderabad
TELANGANA
501102
India |
| Phone |
9246371730 |
| Fax |
|
| Email |
sampathcheruku@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CH Sampath Reddy |
| Designation |
Head Of The Department |
| Affiliation |
Sri Sai College Of Dental Surgery |
| Address |
Department of pedodontics and preventive Dentistry ,SRI SAI COLLEGE OF DENTAL SURGERY, 1-2-64/1&2 , Kothrepally, opp. Shiv Sagar lake, Vikarabad, Telangana 501102.
TELANGANA
501102
India |
| Phone |
9246371730 |
| Fax |
|
| Email |
sampathcheruku@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr.N Devi Vyshnavi,
Postgraduate Student,
Department Of Pedodontics,
Sri Sai College Of Dental Surgery,
1-2-64/1&2 , Kothrepally, opp. Shiv Sagar lake, Vikarabad, Telangana 501102. |
|
|
Primary Sponsor
|
| Name |
Dr N Devi Vyshnavi |
| Address |
Sri Sai College Of Dental Surgery,
1-2-64/1&2 , Kothrepally,
Opp. Shiv Sagar lake, Vikarabad,
Telangana 501102. |
| 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 N Devi Vyshnavi |
Sri Sai College Of Dental Surgery |
Room no.9, Department Of Pedodontics and Preventive Dentistry, Sri Sai College Of Dental Surgery,
1-2-64/1&2, Kothrepally, opp. Shiv Sagar lake, Vikarabad, Telangana 501102.
Hyderabad
TELANGANA |
08904268032
ndvyshnavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE 2021-22 OF SRI SAI COLLEGE OF DENTAL SURGERY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biodentine |
Using biodentine during 20 min long indirect pulp capping procedure |
| Intervention |
Protooth cement |
Using protooth cement during 20 min long indirect pulp capping procedure. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Clinical:
1)The primary molars with no spontaneous pain, no tenderness to percussion or palpation
2)Primary molars with a deep carious lesion approximating pulp.
3)Presence of active carious lesions involving occlusal surfaces of primary molars.
4)Extension of carious lesion such that complete caries removal would risk pulp exposure.
5)Cooperative children and parents willing to follow the instructions and report for follow-up.
Radiographic:
1)No radiographic signs of internal or external root resorption
2)Radiographic evidence of an intact lamina dura.
3)Dental caries close to the pulp.
|
|
| ExclusionCriteria |
| Details |
Clinical:
1)Patients who decline to participate in the study.
2)History of spontaneous sharp, penetrating pain, or tenderness on percussion.
3)Presence of abnormal tooth mobility, fistula, abscess, and swelling of the soft and periodontal tissues.
4)Presence of chronic systemic diseases.
Radiographic:
1)Large carious lesion with radiographic pulp exposure.
2)Presence of interrupted lamina dura, internal or external root resorption, interradicular or periapical pathosis, and widened periodontal ligament space
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical & radiographic success rate of indirect pulp capping in primary molars using protooth and biodentine. |
Baseline, 1 month, 3 months , 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/06/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Carious enamel and
infected dentine will be removed followed by placement of biodentine in group A and protooth cement in group B . Both the
groups will be restored with glass ionomer cement.
The teeth will be
evaluated at 1, 3, 6 and 9 months periodically to assess the clinical and
radiographic outcomes. The data will be subjected to statistical analysis. |