Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515548
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Assessment the Efficacy of Vitamin D Mouth Rinse Versus Placebo in the Treatment of MIH
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment the Efficacy of Vitamin D Mouth Rinse Versus Placebo in the Treatment of Molar Incisor Hypomineralization A Randomized Double-Blind Placebo Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In child patients with molar incisor hypo mineralization Will Vitamin D mouth wash offer more success for patients with MIH as regards better MIH TNI index decrease plaque accumulation more gingival health and less bleeding on probing differentiated from placebo mouthwash
Detailed Description:
Molar incisor hypomineralization MIH refers to specific developmental qualitative defect of the enamel that typically affect 1 to all 4 of the permanent molars and can also involve the permanent incisors
MIH is clinically characterized by morphological enamel defects that can be seen on the occlusal surface of permanent molars and the incisal one-third or more of the incisors result from hypomineralization These defects more or less well-defined opacities that vary in size and can be discoloured from white to yellow brownish The hypomineralized enamel is friable and has inferior mechanical properties as well as reduced modulus of elasticity when compared to sound enamel
As a consequence hypomineralized enamel leads to post-eruptive breakdown and hypersensitivity and it is prone to development of carious lesions and pain Due to pain fragile enamel and increased treatment need at an early point of time in life MIH treatment represents a clinical challenge The well-defined opacities are focal subsurface decalcifications in enamel are commonly associated with extended plaque retention Periodontal disease in children is mainly limited to gingival inflammation and is observed as gingival oedema colour and contour changes bleeding on probe or spontaneous bleeding
Recent study showed that plaque accumulation and gingival inflammation were higher in patients with MIH compared with healthy children and that oral hygiene and gingival health worsened as the severity of MIH increased
Vitamin D plays a pivotal role in many biological functions such as in innate immunity effect the regulation of calcium Ca and phosphate metabolism and their deposition in mineralized tissues Since the presence of Vitamin D3 receptors on ameloblast and odontoblast cells its function in tooth development and remineralization changes in the biochemical composition of saliva and immunological modulation of dental infection has been suggested
Vitamin D has been demonstrated to have significant potential in improving the remineralization of early lesions on enamel surfaces enhancing surface microhardness and minerals content Remineralization is defined as the process whereby calcium and phosphate ions are supplied from a source external to the tooth to promote ion deposiption into crystal voids in demineralized enamel to produce net mineral gain
Recent ex-vivo study revealed that the topical application of fluoride and vitamin D promoted the formation of persistent mineral crystals on enamel surfaces of deciduous teeth Consequently this study recommends further evaluation to be potentially used as an alternative strategy
The treatment of teeth affected by MIH should be a minimally invasive procedure that aims to protect strengthen and preserve dental structure Numerous therapeutic alternatives have been proposed over time for the treatment of MIH-affected teeth but the clinical management of these conditions is very demanding and less conservative
MIH is clinically characterized by morphological enamel defects that can be seen on the occlusal surface of permanent molars and the incisal one-third or more of the incisors result from hypomineralization These defects more or less well-defined opacities that vary in size and can be discoloured from white to yellow brownish The hypomineralized enamel is friable and has inferior mechanical properties as well as reduced modulus of elasticity when compared to sound enamel
As a consequence hypomineralized enamel leads to post-eruptive breakdown and hypersensitivity and it is prone to development of carious lesions and pain Due to pain fragile enamel and increased treatment need at an early point of time in life MIH treatment represents a clinical challenge The well-defined opacities are focal subsurface decalcifications in enamel are commonly associated with extended plaque retention Periodontal disease in children is mainly limited to gingival inflammation and is observed as gingival oedema colour and contour changes bleeding on probe or spontaneous bleeding
Recent study showed that plaque accumulation and gingival inflammation were higher in patients with MIH compared with healthy children and that oral hygiene and gingival health worsened as the severity of MIH increased
Vitamin D plays a pivotal role in many biological functions such as in innate immunity effect the regulation of calcium Ca and phosphate metabolism and their deposition in mineralized tissues Since the presence of Vitamin D3 receptors on ameloblast and odontoblast cells its function in tooth development and remineralization changes in the biochemical composition of saliva and immunological modulation of dental infection has been suggested
Vitamin D has been demonstrated to have significant potential in improving the remineralization of early lesions on enamel surfaces enhancing surface microhardness and minerals content Remineralization is defined as the process whereby calcium and phosphate ions are supplied from a source external to the tooth to promote ion deposiption into crystal voids in demineralized enamel to produce net mineral gain
Recent ex-vivo study revealed that the topical application of fluoride and vitamin D promoted the formation of persistent mineral crystals on enamel surfaces of deciduous teeth Consequently this study recommends further evaluation to be potentially used as an alternative strategy
The treatment of teeth affected by MIH should be a minimally invasive procedure that aims to protect strengthen and preserve dental structure Numerous therapeutic alternatives have been proposed over time for the treatment of MIH-affected teeth but the clinical management of these conditions is very demanding and less conservative
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None