Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201405000707335 Date of Approval: 19/11/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Distal shoe space maintainer
Official scientific title The use of distal shoe appliance to guide the eruption of lower first permanent molar after premature extraction of lower second primary molar
Brief summary describing the background and objectives of the trial One of the most frustrating problems of managing the developing dentition is the premature loss of the second primary molar prior to the eruption of the first permanent molar. In the absence of the second primary molar mesial movement and migration of the permanent molar may be expected to occur before and during its eruption. An unerupted first permanent molar may drift mesialy within the alveolar bone resulting in a loss of arch length and possible impaction of the second premolar.( Liu W 1949, Richardson ME 1965). Holding space to allow the teeth to erupt and to prevent impactions is valuable. A space maintainer that will guide the first permanent, molar into its normal position is indicated. The appliance traditionally suggested to be the treatment of choice is the distal shoe space maintainer (Hicks, 1973; Gegenheimer and Donly, 1992).Unfortunately there is paucity of information regarding such appliance. The available knowledge came from case reports without any published methodological research on such topic ( this finding was obtained from the systematic review done by the principal investigator ) The aim of this study is to evaluate the effectiveness of distal shoe appliance in guiding the eruption of lower first permanent molar after premature extraction of lower second primary molar
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Dental caries
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 12/06/2013
Actual trial start date 13/07/2013
Anticipated date of last follow up 18/10/2014
Actual Last follow-up date 20/11/2013
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 15
Recruitment status Recruiting
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
Non-randomised Masking/blinding used
Non-randomised Masking/blinding used
Non-randomised Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Distal shoe space maintainer 1 year The lower seound primary molar will be exracted and a ditsal show space maintainer fitted and the position of the distal extention will be verified by a periapical radiograph 15 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Lower second primary molar indicated for extraction Lower first permanent molar did not erupt yet Patients with any systemic disease that may affect normal healing Lower first primary molar in the same quadrant indicated for extraction or extracted Poor patient or parental cooperation Cardiac anomalies that require antibiotic prophylaxis prior to dental treatment 5 Year(s) 6 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 09/10/2013 Ethics commitee, Faculty of oral and dental Medecine
Ethics Committee Address
Street address City Postal code Country
Saraya El Manial Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of space loss will be measured using a digital caliper By measuring the space between lower first primary molar and lower first permanent molar after its appearance in the oral cavity, then subtracting it from the mesiodistal width of lower second primary molar ( obtained from the pre-operative cast) Eruption of the lower first permanent molar
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Oral and Dental Medicine out patient Saraya el manial Cairo Egypt
Pedodontic department outpatient Saraya El manial Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding 146 Elbahr Elazaam Street Giza 12211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Kamal Elmotayam 146 elbahr elazam giza 12211 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Sherine Ezz Eldin 1 Saraya Elmanial ( Faculty of Dentistry ) Cairo Egypt
Adel El Bardissy 1 Saraya Elmanial ( Faculty of Dentistry ) Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed elmotayam elmotayam@msn.com +201116903155 146 elbahr elazam
City Postal code Country Position/Affiliation
giza 12211 Egypt assistant lecturer, department of pedodontics, Cairo university
Role Name Email Phone Street address
Public Enquiries Ahmed hosni Elkhadem a_elkhadem@hotmail.com +201227520298 1 Saraya elmanial
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer, department of pedodontics, Faculty of Dentistry, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Ahmed hosni Elkhadem a_elkhadem@hotmail.com +201227520298 1 Saraya elmanial
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer, department of pedodontics, Faculty of Dentistry, Cairo university
REPORTING
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Changes to trial information