Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-05 @ 6:23 PM
Study NCT ID:
NCT01243866
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2010-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dental Treatment on Children's Growth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-18', 'studyFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's height and weight (HAZ,WAZ and BAZ)", 'timeFrame': '6 months', 'description': "children's height and weight were measured pre and 6 months post dental treatment."}], 'secondaryOutcomes': [{'measure': 'Quality of life (pain, sepsis, satisfaction and appetite)', 'timeFrame': '6 months', 'description': 'specific general and oral quality of life health measures were examined before and after dental treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dental Decay']}, 'referencesModule': {'references': [{'pmid': '22928903', 'type': 'DERIVED', 'citation': "Alkarimi HA, Watt RG, Pikhart H, Jawadi AH, Sheiham A, Tsakos G. Impact of treating dental caries on schoolchildren's anthropometric, dental, satisfaction and appetite outcomes: a randomized controlled trial. BMC Public Health. 2012 Aug 29;12:706. doi: 10.1186/1471-2458-12-706."}]}, 'descriptionModule': {'briefSummary': "Severe dental decay affects children physically, emotionally, socially and thereby impacts on their quality of life. Evidence from developed countries showed that children with severe dental decay weighed less than their peers and following dental treatment children's growth and quality of life improved. This suggests that treatment of severe dental decay may enhance growth and wellbeing. A study was carried out in Saudi to test that hypothesis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '95 Months', 'minimumAge': '72 Months', 'eligibilityCriteria': 'Inclusion Criteria:\n\nHaving dental caries with at least 2 teeth with pulpal involvement.\n\nExclusion Criteria:\n\n1. Children with illness known to adversely affect growth.\n2. Children who required urgent dental treatment.\n3. Children on regular nutritional supplements.\n4. Anaemic children with Hb levels lower than 11.0 g/dl'}, 'identificationModule': {'nctId': 'NCT01243866', 'briefTitle': "Effect of Dental Treatment on Children's Growth", 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Fahad Armed Forces Hospital'}, 'officialTitle': "Effect of Dental Treatment on Children's Growth", 'orgStudyIdInfo': {'id': 'MD109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early treatment', 'description': 'comprehensive dental treatment', 'interventionNames': ['Other: comprehensive dental treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Regualr treatment', 'description': 'Regular treatment consisted of children who would be on a waiting list for regular dental treatment at KFAFH for at least 8 months', 'interventionNames': ['Other: Only emergency dental treatment']}], 'interventions': [{'name': 'comprehensive dental treatment', 'type': 'OTHER', 'description': 'Early treatment children were scheduled for comprehensive dental treatment over a 2-month period (from May to June 2007). All test children had their last dental treatment visit within the last 2 weeks of the second treatment month. The follow-up survey was scheduled for each child to be approximately 6-month after their dental last visit. This step was very important to make sure that all children were examined at exactly the same interval between end of treatment and when re-examined at the follow-up examination.', 'armGroupLabels': ['Early treatment']}, {'name': 'Only emergency dental treatment', 'type': 'OTHER', 'description': 'Regular treatment did not receive any dental treatment in the period when the early children were treated unless they had toothache or dental infection. In that case they were treated for the pain but did not have comprehensive dental treatment', 'armGroupLabels': ['Regualr treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hiba A Alkarimi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KFAFH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Fahad Armed Forces Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr Hiba Alkarimi', 'oldOrganization': 'King Fahad Armed Forces Hospital'}}}}