FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/06/019831 [Registered on: 24/06/2019] Trial Registered Prospectively
Last Modified On: 22/06/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Effectiveness of placing crowns without tooth preparation and removing decay 
Scientific Title of Study   Effectiveness of a simplified method (Hall’s Technique) of managing caries primary molar teeth in young children using preformed metal crowns. 
Trial Acronym  Hall Technique - clinical trial 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A Balamurugan 
Designation  Tutor in Dentistry 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Room no 4, Ground floor Department of Peadodontics and Preventive Dentistry, Faculty of Dental Sciences, SRIHER SRPorur, Chennai.
Room no C-018 Gents hostel SRIHER campus, Porur, Chennai - 116
Thiruvallur
TAMIL NADU
600116
India 
Phone  8056044576  
Fax    
Email  balafo@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  A BALAMURUGAN 
Designation  Tutor in Dentistry 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Room no 4, Dept of Paedodontics and Preventive Dentistry, Faculty of Dental Sciences, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai

Thiruvallur
TAMIL NADU
600116
India 
Phone  8056044576  
Fax    
Email  balafo@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  A BALAMURUGAN 
Designation  TUTOR IN DENTISTRY 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Room no 4, Dept of Paedodontics and Preventive Dentistry, Faculty of Dental Sciences, Sri Ramachandra Institue of Higher Education and Research, Porur, Chennai.

Thiruvallur
TAMIL NADU
600116
India 
Phone  8056044576  
Fax    
Email  balafo@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
3 M, Health care Business, Seshachalam Centre, 11th Floor, 636/1, Annasalai, Chennai - 600035 
 
Primary Sponsor  
Name  Three M 
Address  3M HealthCare buisness, Seshachalam Centre, 11th Floor, 636/1, Anna Salai. Chennai 600035 
Type of Sponsor  Other [Dental Material company] 
 
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 A Balamurugan  Sri Ramachandra Institute of Higher Education and Research  Room no 4, Dept of Paedodontics and Preventice Dentistry, Porur, Chennai
Thiruvallur
TAMIL NADU 
8056044576

balafo@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SRIHER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children with dental caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Participants aged 3 to 8 years of age
2. No relevant medical history
3. No symptoms of reversible pulpitis (Pain on eating)
4. OPG or Bitewings, IOPA radiographs available
5. No inter-radicular radiolucency on the selected primary molar tooth
 
 
ExclusionCriteria 
Details  1. Participants with special healthcare needs and developmental anomalies.
2. Caries involving pulp.
3. Radiographically radiolucency extending beyond a middle third of dentine.
4. Previous symptoms of nocturnal pain, inter-radicular radiolucency.
5. Clinical signs or symptoms of irreversible pulpitis, dental abscess or mobility. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clincial effectiveness and acceptability of the Hall Technique in young children between 3 to 8 years  Thirty Six months 
 
Secondary Outcome  
Outcome  TimePoints 
Lifespan of Stainless Steel crown with Halls Technique  Thirty Six months 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   25/06/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Innes N.P., Evans D.J., Stirrups D.R. 2007. The Hall Technique; A randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: Acceptability of the technique and outcomes at 23 months. BMC Oral Health; 7. http://www.biomedcentral.com/1472-6831/7/18 2. Innes, N.P.T., Stirrups, D.R., Evans, D.J.P., Hall, N. and Leggate, M., 2006. A novel technique using preformed metal crowns for managing carious primary molars in general practice - A retrospective analysis. British Dental Journal, 200(8), pp. 451-454. 3. Innes N.P.T., Evans D.J.P., Stirrups D.R., 2006. Clinical pulpal responses to sealing caries into primary molars: 2 year results of an RCT. Caries Research, 40: 327. 10. 4. Innes NPT, Evans DJP. Hall N., 2009. The Hall Technique for managing carious primary molars. Dental Update, 36:472-478.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Stainless steel crowns have been recommended in the literature as restorative material of choice in primary molars with multi surface caries involvement, following pulp therapy and in children at high risk of dental caries. It has been considered most cost effective since they don’t require frequent replacement. Generally stainless steel crowns are considered in the following situation: high risk patients with single surface/ multi surface caries/ demineralization under eight years of age; after pulp therapy; teeth with extreme wear facets and more than two years before exfoliation. Despite SSC being recommended as the ideal restoration for managing primary molar where caries involves two or more surfaces and evidence of their effectiveness, SSC are not widely used. The standard techniques involves tooth preparation under local anesthesia which was not widely accepted by the preschool children. This lead to a novel simplified method of using SSC, the Hall Technique being investigated. This method uses SSC which are filled with Antidecay cement (GIC) and simply pushed onto the tooth with no caries removal or tooth preparation. Efficient sealing / cementing enhances the success of restoration by preventing bacterial ingress and further progress of the lesion. With the Hall Technique, the process of fitting the crown is quick and non-invasive. The crown is seated over the tooth with no caries removal or tooth preparation of any kind, and local anesthesia is not required. By doing this technique there will be no impact to developing tooth, if any caries left untreated which will have impact over the developing permanent tooth, so based on the extend of the caries they need to be treated either as restoration or with SSC. There is no risk for doing this procedure in children, this makes the child more comfortable for the procedure.

 

 
Close