Trial document





This trial has been registered retrospectively.
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  DRKS00005955

Trial Description

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Title

Comprehensive Oral Health Care Program for Filipino Children

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Elementary schools were selected in the rural areas of Misamis Oriental, Mindanao, the Philippines, by the Department of Education with regards of accessibility. These were included in a comprehensive oral health program. As the oral health status of the children was very poor, the preventive program focused on primary prevention (daily tooth brushing with fluoride toothpaste, quarterly application of fluoride varnish, health promotion to the children, parents and teachers) as well as providing tertiary preventive measures (fillings for restorable permanent teeth and extraction of non-restorable teeth).
The children were treated outdoors in the schoolyard, lying in a supine position on school benches. No electricity was available. Caries excavation and restoration were performed using hand instruments only. Conventional visual, tactile and auditive criteria were used to guide caries excavation. Encapsulated Amalgam was mixed with a manually driven amalgamator.
At the end of the 5-year oral health care program the status of the restorations was examined. The dentition status of the children was assessed according to the WHO Standards after tooth brushing. The MRT-restorations were evaluated using criteria similar to that used in previous ART-studies.

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Brief Summary in Scientific Language

Elementary schools were selected in the rural areas of Misamis Oriental, Mindanao, the Philippines, by the Department of Education with regards of accessibility. These were included in a comprehensive oral health program supported by the German non-governmental organisation “German Doctors” which started in 1998.
As the oral health status of the children was very poor, the preventive program focused on primary prevention (daily tooth brushing with fluoride toothpaste, quarterly application of fluoride varnish, health promotion to the children, parents and teachers) as well as providing tertiary preventive measures (restorative treatment and extraction of non-restorable teeth).
All cavitated lesions without obvious clinical pulp involvement were considered restorable and all children with restorable carious lesions in permanent teeth received MRT restorative treatment.
The children were treated outdoors in the schoolyard, lying in a supine position on school. No electricity was available. Caries excavation, cavity preparation and restoration were performed using hand instruments only. Conventional visual, tactile and auditive criteria were used to guide caries excavation Encapsulated non-gamma-2 amalgam (Amalcap®, Ivoclar Vivadent AG, Liechtenstein) was mixed with a manually driven amalgamator.
At the end of the 5-year oral health care program the status of the restorations was examined. All examinations were carried out outdoors in a half-shaded location, using sunlight as the light source. The dentition status of the children was assessed according to the WHO Standards after tooth brushing. The MRT-restorations were evaluated using criteria similar to that used in previous ART-studies.

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Organizational Data

  •   DRKS00005955
  •   2014/03/20
  •   [---]*
  •   yes
  •   Approved
  •   PHREB 1026, Xavier University - Ateneo de Cagayan
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Secondary IDs

  •   U1111-1153-9973 
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Health Condition or Problem studied

  •   K02 -  Dental caries
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Interventions/Observational Groups

  •   All children in selected elementary schools with restorable permanent teethreceive:
    1. primary preventive measures: supervised daily tooth brushing with fluoride toothpaste, quarterly application of fluoride varnish, health promotion to the children, parents and teachers and 2.tertiary preventive measures: restorative treatment of restorable teeth with dental amalgam using hands instruments only and extraction of non-restorable teeth.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Oral health improvement measured by care-Index.
Increase of filled teeth ratio (FT) of all teeth with caries prevalence (DMFT): over 30 % increase after 3 years and over 50% after 5 years.

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Secondary Outcome

clinically succesful restorations (ART-quality codes 0 and 1) after up to 5 years service time

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Countries of Recruitment

  •   Philippines
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   1998/08/05
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   15   Years
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Additional Inclusion Criteria

restorable permanent teeth

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Exclusion Criteria

none

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Addresses

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    • Committee of German Doctors
    • Ms.  Dr.  Bella  Monse 
    • Mortola Hayes Street
    • 9000  Cagayan de Oro
    • Philippines
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    • Universitätsklinikum JenaPoliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Prof. Dr.  Roswitha  Heinrich-Weltzien 
    • Bachstraße 18
    • 07743  Jena
    • Germany
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    • Committee of German Doctors
    • Ms.  Dr.  Bella  Monse 
    • Mortola Hayes Street
    • 9000  Cgayan do Oro
    • Philippines
    end of 1:1-Block address scientific-contact
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    • Committee of German Doctors
    • Ms.  Dr.  Bella  Monse 
    • Mortola Hayes Street
    • 9000  Cagayan de Oro
    • Philippines
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Sources of Monetary or Material Support

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    • Committee of German Doctors
    • Mortola Hayes Street
    • 9000  Cagayan do Oro
    • Philippines
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    •   +63 905 377 7684
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2003/09/07
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* This entry means the parameter is not applicable or has not been set.