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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Children with dental caries |
|
Intervention / Comparator Agent
|
|
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.
|