Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201810790493140 Date of Approval: 15/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of two methods of stainless steel crown treatment in treating teeth cavities in children
Official scientific title Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the Hall technique in the treatment of carious primary molars
Brief summary describing the background and objectives of the trial Background: Dental caries is a multifactorial disease that causes reversible decalcification and cavitation of susceptible teeth exposed to sugary substrates over a period of time in the oral cavity. It gives clinical and social burdens to the child patients and their parents/carers. Stainless steel crown restoration is one of the restorative treatment options in the management of carious primary molars. The Hall technique is a biologic method of managing primary teeth by sealing in the caries with stainless steel crowns (SSCs). Objectives: The objectives of this study were to assess and compare the primary and secondary treatment outcomes of stainless steel crown restorations using the conventional method and the Hall technique in primary molars immediately after placement and over a 12 month period using both clinical and radiological parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/01/2014
Actual trial start date 27/01/2014
Anticipated date of last follow up 23/01/2015
Actual Last follow-up date 30/04/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hall technique 12 month review The protocol for the Hall Technique stainless steel crown (SSC) was as follows: obvious food or debris was removed from the cavity with spoon excavator, but no caries was removed. The child was positioned upright in the dental chair to reduce the chance of accidental swallowing or aspiration of a loose SSC. Additional airway protection was gained by the use of a gauze swab behind the tooth or by securing the SSC with a strip of Elastoplast. Crown selection was done using a pair of dividers and a ruler; the mesiodistal width of the tooth was measured with a pair of dividers and a ruler. The appropriate SSC that matched the measured mesio-distal width of the tooth was selected i.e. covering all cusps and giving a feeling of “spring back” when placed up to , but not through the contact points. Orthodontic separator elastics were used for tight contacts and the SSC was fitted at the subsequent appointment (i.e. a week). The tooth was rinsed and dried, the SSC (Kids Crown, Shinhung, Korea) was dried. The SSC was filled with glass ionomer luting cement (Hy-Bond Glasionomer CX, Shofu Inc, Japan). The SSC was then placed over the tooth evenly and digital pressure was used to seat the crown. Extruded cement was removed and the child was asked to keep biting on the crown until the cement had set. Once set, excess cement was removed, dental floss was used to clear the approximal contacts, and post- fitting instructions were given 25
Control Group Conventional stainless steel crown restoration method !2 mpnths The protocol for the placement of the conventional SSC (Kids Crown, Shinhung, Korea) restoration was as follows: Pre-operative occlusion was evaluated, then appropriate local anesthesia was administered. Rubber dam was placed (the adjacent tooth was clamped). Prior to preparation, all caries was removed. Crown selection was done using a pair of dividers and a ruler; the mesiodistal width of the tooth was measured with a pair of dividers and a ruler. The appropriate SSC that matched the measured mesio-distal width of the tooth was selected. 1.5mm occlusal, mesial and distal reductions were done with tapered diamond bur. The mesial and distal surfaces of the tooth are removed using a fine tapered fissure bur. The tooth was cut through away from the contact to avoid damage to the adjacent tooth. The bur was angled away from the vertical so that a shoulder is not created at the gingival margin. A larger diamond bur was used to reduce the occlusal surface to 1.5-2mm of space between the prepared tooth and its opposite number. The crown was tried on the tooth and checked to feel that it is within the gingival crevice by probing. The crown was crimped with crimping pliers if it rested on the gingival crevice. Contouring pliers was used to produce a belling effect in the middle third of the crown. The crown was seated again and checked for over-extension which was diagnosed by blanching of the gingival tissue. If it was over-extended, it was cut down with a crown scissors and smoothened off with a large stone bur before retrying. The contacts with the adjacent teeth were checked and the margins of the crown were polished with a stone or rubber wheel. Post-operative occlusion was evaluated. The tooth was washed and dried before cementation with glass ionomer cement (Hy-Bond Glasionomer CX, Shofu Inc, Japan). The crown was seated from lingual to buccal pressing down firmly. Excess set cement was removed with a probe and dental floss. The rubber dam was then removed. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects with pair(s) of unrestored carious primary molars at high risk of dental caries were included. Study teeth were matched for tooth type, dental arch, and extent of caries which showed enamel or dentine caries on bitewing radiographs. Study teeth were symptomless, with no clinical or radiographic signs of pulpal pathology on bitewing radiographs. Subjects who did not give consent/assent or were unwilling to participate in the study, those with chronic medical conditions e.g. leukemia, sickle cell disease, those with teeth that were mobile, symptomatic, abscessed or teeth tender to percussion and those with teeth with radiographic signs of pulpal pathology on bitewing radiographs were excluded from the study. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 8 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/01/2014 Lagos University Teaching Hospital Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi-araba Lagos 101014 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Major failures e.g irreversible pulpitis, dental abscess, peri-radicular radiolucency and crown loss with the tooth unrestorable. 12 months
Secondary Outcome Minor failures like crown loss with the tooth restorable, crown perforation, secondary/marginal caries and reversible pulpitis 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi-araba Lagos 101014 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ayedun Oladipupo 38 Somosu Street Lagos 101014 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Lagos University Teaching Hospital Idi-araba Lagos 101014 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayedun Oladipupo oayedun@unilag.edu.ng +2347030405475 Idi-araba
City Postal code Country Position/Affiliation
Lagos 101014 Nigeria Lecturer 1
Role Name Email Phone Street address
Public Enquiries Oredugba Folakemi fola_ored@yahoo.com +2348023414755 Idi-araba
City Postal code Country Position/Affiliation
Lagos 101014 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Sote Elizabeth lizsote@yahoo.co.uk +2348023085812 Idi-araba
City Postal code Country Position/Affiliation
Lagos 101014 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Results: Twenty three subjects returned for follow up. There was no statistically significant difference (p-value > 0.05) between the conventional SSC restoration and the Hall technique for both the primary outcomes/major failures (irreversible pulpitis, dental abscess, peri-radicular radiolucency and crown loss with tooth unrestorable) and secondary outcomes/minor failures (crown loss and tooth restorable, crown perforation, secondary/marginal caries and reversible pulpitis). But, there was a statistical significant difference in the average time taken for the placement of the restorations between the two groups (p-value 0.001). 11/10/2018 11/10/2018
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks It is not available
Changes to trial information