| CTRI Number |
CTRI/2025/12/098831 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing 3 Different Types Stainless Steel of Cap Placement Methods in Children: Minimally invasive methods s Standards Methods of Cap Placement in Lower Molar Teeth of Children |
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Scientific Title of Study
|
Comparative Evaluation of Clinical and Radiographic Success of Three Stainless Steel Crown Techniques in Primary Mandibular Molars and Oral Health related Quality of Life Assessment: A Prospective, Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishwarya S |
| Designation |
Postgraduate Student |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College and Hospital, Mount Poonamallee Road, Sri Ramachandra Nagar, Porur, Chennai - 600116
Chennai
TAMIL NADU
600116
India
Chennai
TAMIL NADU
600116
India |
| Phone |
7358241208 |
| Fax |
|
| Email |
drishwarya.shan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arulpari M |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College and Hospital, Mount Poonamallee Road, Sri Ramachandra Nagar, Porur, Chennai - 600116
Chennai
TAMIL NADU
600116
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9942364100 |
| Fax |
|
| Email |
arulpari2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arulpari M |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College and Hospital, Mount Poonamallee Road, Sri Ramachandra Nagar, Porur, Chennai - 600116
Chennai
TAMIL NADU
600116
India
TAMIL NADU
600116
India |
| Phone |
9942364100 |
| Fax |
|
| Email |
arulpari2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| The trial will receive essential equipment and supplies, including dental instruments, imaging devices (e.g., intraoral radiography), and materials for crown placement and cementation, from the Department of Pediatric and Preventive Dentistry at Sri Ramachandra Dental College and Hospital. |
|
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Primary Sponsor
|
| Name |
Ishwarya S |
| Address |
Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College, Mount Poonamallee Road, Sri Ramachandra Nagar, Porur, Chennai - 600116 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ishwarya S |
Department of Pediatric and Preventive Dentistry, Sri Ramachandra Dental College and Hospital, |
Sri Ramachandra Dental College and Hospital, Mount Poonamallee Road, Sri Ramachandra Nagar, Porur, Chennai - 600116
Chennai
TAMIL NADU |
7358241208
drishwarya.shan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Non-medical PG and UG Students |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Technique |
Pre-operative radiographs and clinical photos will be taken. Caries is excavated using a round diamond bur (Dental Mani Diamond Burs). Occlusal reduction of 1.5 to 2 mm is done using 169L bur with the preservation of occlusal contour of the cusps. Proximal surfaces will be reduced using 169L bur (SS White Dental Carbide Burs – FG 169L) by establishing a feather finish line gingivally without damaging the adjacent tooth. Buccal or lingual reduction is optional, but if done, should not extend more than 0.5 to 1 mm. Occluso-lingual and occluso-buccal line angles are bevelled at 45 degrees. After ensuring adequate preparation of the tooth, it is tried linguo-buccally. To ensure better fit, the stainless steel crown is crimped with No. 114 Johnson contouring pliers and 1 mm of cervical margin is crimped circumferentially with crimping pliers.
The crown is cemented with type I Glass Ionomer cement (GC Gold Label Luting and Lining Cement) and finger pressure is applied, followed by removal of excess cement. Post-operative clinical photographs and radiographs will be taken. Duration of this intervention will be for a maximum of 1 hour.
|
| Intervention |
Hall Technique
|
Pre-operative radiographs and clinical photos will be taken.
For tight contact points, orthodontic separators are placed through the mesial and distal contacts with an elastic separating forceps. In the second appointment after 3-5 days, the separators are removed. Separators are not mandatory if the contact points are not tight. Airway is protected by making the child sit upright and gauze is placed between the tongue and the tooth. Crown selection (3M ESPE, St. Paul, Minn., USA) is made with the smallest size of crown that covers all the cusps and with a slight feeling of “spring back”. After appropriate crown selection, the crown is cemented with type I GIC luting cement and finger pressure is applied, followed by removal of excess cement. Post-operative clinical photographs and radiographs are taken.
Duration of this intervention will be for a maximum of 30 minutes.
|
| Intervention |
Modified Hall Technique |
Pre-operative radiographs and clinical photos will be taken. 1 mm proximal slicing is done and / or minimal occlusal reduction of the cusps is done. Similar protocol done in conventional and Hall technique for crown placement is followed in Modified Hall technique. Duration of this intervention will be for a maximum of 45 minutes. |
|
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 4-8 years
Primary mandibular molars with cavitated Class I and II caries (with Remaining dentin thickness not less than 1 mm)
Permanent 1st molar should be erupted if primary mandibular second molar is considered
No signs of pulpal or periapical pathology, or internal or external resorption
|
|
| ExclusionCriteria |
| Details |
Presence of root resorption of more than one-third of root
Presence of pulpal or periapical pathologies
Presence of tooth mobility
Children with underlying medical conditions or special healthcare needs
Patients unwilling to participate
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Determining the clinical and radiographic success or failure of stainless steel crown placement after a 12 month period.
The success of the crown placement will be assessed clinically for gingival health, plaque accumulation, marginal integrity, wear of the crown and occlusion. Radiographically, it will be assessed by the presence of secondary caries, furcation radiolucency, widening of periodontal ligament and bone resorption
|
Clinical and radiographic evaluation will be conducted at intervals of 1, 3, 6 and 12 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the oral health related quality of life of the patients undergoing stainless steel crown technique. |
A modified version of the Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire will be administered to the parents at intervals of 1, 3, 6 and 12 months |
|
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Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 2 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) - The data will be used to present at the conferences or conventions that are a part of the PG curriculum
- For how long will this data be available start date provided 15-05-2025 and end date provided 15-10-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
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Brief Summary
|
This study Is a prospective, randomised, parallel-group clinical trial comparing the clinical and radiographic outcomes of placement of stainless steel crown with Hall, Modified Hall and conventional techniques in cavitated primary mandibular molars. Pediatric patients reporting to the Department of Pediatric and Preventive Dentistry, SRIHER, who meet the inclusion criteria will be recruited. Children who meet the inclusion criteria will be randomly allocated to either of the 3 groups based on the randomization list.
Study group (Group A): Hall technique
Study group (Group B): Modified Hall technique
Control group (Group C): Conventional technique
The primary outcome of this study will be determining the success of the stainless steel crown placement after 12 months. To be categorized as having overall success, the evaluated tooth must demonstrate both clinical and radiographic success. Clinical and radiographic evaluation will be conducted at intervals of 1, 3, 6 and 12 months. Additionally, the oral health related quality of life of the children undergoing these techniques will be assessed using a modified version of the Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire.
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