Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03971084
Status:
UNKNOWN
Last Update Posted:
2021-10-18
First Post:
2019-05-22
Brief Title:
Impact of Chewing Gum With CPP-ACP on Tooth Mineralisation in Situ
Sponsor:
Mondelēz International Inc
Organization:
Mondelēz International Inc
Study Overview
Official Title:
Impact of Chewing Gum Containing CPP-ACP on Tooth Mineralisation Using an in Situ Appliance in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Monocentric randomised double-blind cross-over controlled study with two arms
This study aims to analyse the impact on mineralisation of Sugar Free Gum SFG containing CPP-ACP in healthy adults
This study aims to analyse the impact on mineralisation of Sugar Free Gum SFG containing CPP-ACP in healthy adults
Detailed Description:
There is some promising evidence in the literature to support a significant favourable impact of the consumption of Sugar Free Gum SFG containing casein phosphopeptide-amorphous calcium phosphate CPP-ACP on tooth mineralisation and especially on the promotion of tooth remineralisation over and above the well-established role of regular SFG in humans
This study is a monocentric randomised double-blind cross-over and controlled study The research hypothesis is that chewing a SFG containing CPP-ACP from Recaldent will better remineralise the enamel in healthy subjects compared with regular SFG after 2 weeks of gum chewing 5 times a day for 20 minutes within 5 minutes after each meal and snack occasion with a CPP-ACP dose of 188 mg per SFG This will be studied with an in situ model study with palatal appliances bearing recessed 15mm human demineralised enamel blocks with caries-like lesions subsurface lesions which should be worn 24 h a day by the subjects including during eating and drinking but the appliances should be removed for daily oral hygiene procedure and cleaning of the appliance itself Each appliance will contain two types of the demineralised enamel blocks half of the blocks will contain shallow subsurface lesions Carbopol method and the other half reflecting deeper subsurface lesions hydroxy-ethyl cellulose method Both types of lesions have been the subject of oral research interest as both shallow and deep lesions are involved in caries genesis Changes in mineralisation of the lesions will be assessed using Transverse Microradiography TMR
This study is a monocentric randomised double-blind cross-over and controlled study The research hypothesis is that chewing a SFG containing CPP-ACP from Recaldent will better remineralise the enamel in healthy subjects compared with regular SFG after 2 weeks of gum chewing 5 times a day for 20 minutes within 5 minutes after each meal and snack occasion with a CPP-ACP dose of 188 mg per SFG This will be studied with an in situ model study with palatal appliances bearing recessed 15mm human demineralised enamel blocks with caries-like lesions subsurface lesions which should be worn 24 h a day by the subjects including during eating and drinking but the appliances should be removed for daily oral hygiene procedure and cleaning of the appliance itself Each appliance will contain two types of the demineralised enamel blocks half of the blocks will contain shallow subsurface lesions Carbopol method and the other half reflecting deeper subsurface lesions hydroxy-ethyl cellulose method Both types of lesions have been the subject of oral research interest as both shallow and deep lesions are involved in caries genesis Changes in mineralisation of the lesions will be assessed using Transverse Microradiography TMR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None