| CTRI Number |
CTRI/2024/02/062626 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of clinical efficiency of two tooth coloured, 3D printed resin crowns versus stainless steel crowns for primary molars |
|
Scientific Title of Study
|
Comparison of clinical efficiency of two tooth coloured, 3D printed resin crowns: the endocrowns and the full coverage crowns, versus stainless steel crowns for primary molars – an observational 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 Aroonika Bedre |
| Designation |
PG student |
| Affiliation |
SRM dental college, ramapuram |
| Address |
Dept. of Paediatric and Preventive dentistry, Room no 6, SRM dental college, bharathi salai, ramapuram, chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
8807040124 |
| Fax |
|
| Email |
aroonika.bedre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aroonika Bedre |
| Designation |
PG student |
| Affiliation |
SRM dental college, ramapuram |
| Address |
Dept. of Paediatric and Preventive dentistry, Room no 6, SRM dental college, bharathi salai, ramapuram, chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
8807040124 |
| Fax |
|
| Email |
aroonika.bedre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar P |
| Designation |
Reader |
| Affiliation |
SRM dental college, ramapuram |
| Address |
Dept. of Paediatric and Preventive dentistry, Room no 6, SRM dental college, bharathi salai, ramapuram, chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9884585808 |
| Fax |
|
| Email |
pedoshankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Pediatric Dentistry and Preventive Dentistry, SRM dental college, Ramapuram, Chennai. |
|
|
Primary Sponsor
|
| Name |
Dr Aroonika Bedre |
| Address |
plot 940, 69th street, 11th sector, west K.K nagar, chennai - 78 |
| 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 Aroonika Bedre |
SRM dental college |
Dept. of Paediatric and Preventive dentistry, Room no 6.
Chennai
TAMIL NADU |
8807040124
aroonika.bedre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD SRM DENTAL COLLEGE |
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 |
| Intervention |
Full coverage resin crown (Group B) |
After pulpectomy, tooth preparation will be done. An impression will be taken followed by designing, 3D printing and cementation of the full coverage resin crown.Duration of the intervention will be 6 months. |
| Intervention |
Resin endocrown (Group A) |
After pulpectomy, tooth preparation will be done. an impression will be taken followed by designing, 3D printing and cementation of the resin endocrown. Duration of the intervention will be 6 months. |
| Comparator Agent |
Stainless steel crown (Group C) |
After pulpectomy, tooth preparation will be done, followed by cementation of stainless steel crown.Duration of the intervention will be 6 months. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1) Children aged between 4 to 8 years falling under Frankl’s behavior rating scale criteria 2, 3 and 4.
2) Presence of at least one carious maxillary or mandibular primary molar indicated for pulpectomy.
3) Primary molars with irreversible pulpitis or non-vital pulp which show a restorable tooth structure (adequate sound coronal tooth structure) and have an adequate periodontal support which is confirmed by periapical radiographic examinations.
4) Children whose parents gave consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) Children with special health care needs.
2) Children with underlying any systemic conditions.
3) Children who are allergic to local anaesthesia or any of the materials used in the study.
4) Teeth which show extensive mobility, and advanced root resorption or other indications for extraction
5) Carious teeth exhibiting pre shedding mobility.
6)The presence of bone rare fraction involving more than a half of the root, severe mobility or resorption of more than half of the root or root perforations.
7) Tooth with underfilled or overfilled obturation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The functional, biological and aesthetic properties of 3D printed resin endocrowns and full coverage crowns are comparable to that of stainless steel crowns. |
1, 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The periodontal health of primary molars restored with 3D printed endocrowns and full coverage crowns are comparable to that of stainless steel crowns. |
1, 3 and 6 months. |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| 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="1"
Months="3"
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
|
45 teeth fulfilling the inclusion criteria will be included in the study and randomly sorted into Group A, Group B and Group C (control). Detailed medical history, clinical examination and necessary radiographic investigation will be done. Informed consent will be obtained. Pulpectomy will be performed in the primary molars. 3D printed resin endocrowns will be cemented in 15 teeth (Group A ), 3D printed full coverage crowns will be cemented in 15 teeth (Group B) and stainless steel crowns will be cemented in 15 teeth (Group C). Revised FDI criteria will be used to assess the functional, biological and aesthetic properties of the crowns at 1, 3 and 6 months. Periodontal health will be assessed using the plaque index (PI) and Gingival Index (GI) at 1, 3 and 6 months. Intergroup comparison of clinical efficiency will be computed by Chi – square test. Repeated ANOVA test will be done to analyze the data collected at 1, 3 and 6 months. Intergroup comparison of plaque and gingival scores will be computed using independent t test. |