Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531720
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Comparison of the Effects of Oral Ulceration Healing in Patients Wearing a Removable Denture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the Effects of Mucosa Tissue Healing in Patients Wearing a Removable Prosthetic Restoration - Pilot Study
Status:
COMPLETED
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:
MUCOSA HEALING
Brief Summary:
The aim of the study was comparing the effectiveness of oral mucosa healing properties of different preparations CHX02 chorhexidine digluconate CHS87 choline salicylate CONcontrol group in patients with delivered removable dentures during the adaptation period
Detailed Description:
The efficacy of oral topical medications in aiding regeneration and healing of oral soft mucosa caused by the use of removable prosthetic restorations was analyzed These medications with different functional properties are recommended for patients who develop oral mucosa lesions during adaptation to new removable prostheses The evaluation of the efficacy of these agents was based on a comparison of the area of OML before and after the treatment The study was designed to evaluate healing after the application of a topical medication containing 02 chlorhexidine digluconate and 87 choline salicylate as an active ingredient
Patients were asked to use topical medication 3 times a day applying the size of a pea on the oral mucosa lesion Participants in groups CHX and CHS were instructed not to eat or drink for 1 hour following the application of medication because of its functional and antibacterial properties Patients were asked to wear new dentures between control visits even when they felt discomfort while using them Patients in the control group were not using any topical medication According to randomization patients suffering from oral mucosa lesion OML were divided into three groups
Using a transparent millimeter grid superimposed on the OML the Wound Surface Area WSA was measured in mm2 A very precise measurement of the WSA was possible thanks to the use of a millimeter scale on the digital photo image Every even partially filled square was included in the area of the OML Graphical analysis using Photo for Windows Software consisted of adding all the squares within which the OML was observed All the intraoral images of OML have been taken in reproducible conditions ambient light lens and camera settings distance 5 cm This measurements were carried out during all check-up visits on day 0 1 4 7 and 14
Patients were asked to use topical medication 3 times a day applying the size of a pea on the oral mucosa lesion Participants in groups CHX and CHS were instructed not to eat or drink for 1 hour following the application of medication because of its functional and antibacterial properties Patients were asked to wear new dentures between control visits even when they felt discomfort while using them Patients in the control group were not using any topical medication According to randomization patients suffering from oral mucosa lesion OML were divided into three groups
Using a transparent millimeter grid superimposed on the OML the Wound Surface Area WSA was measured in mm2 A very precise measurement of the WSA was possible thanks to the use of a millimeter scale on the digital photo image Every even partially filled square was included in the area of the OML Graphical analysis using Photo for Windows Software consisted of adding all the squares within which the OML was observed All the intraoral images of OML have been taken in reproducible conditions ambient light lens and camera settings distance 5 cm This measurements were carried out during all check-up visits on day 0 1 4 7 and 14
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