Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363955
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-04-05
Brief Title:
Assessing the Efficacy of a Carbamide Peroxide Mouthwash for Oral Wound Healing Oral Hygiene and Xerostomia Relief
Sponsor:
National and Kapodistrian University of Athens
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
A Randomized Placebo-Controlled Clinical Trial Assessing the Efficacy of a Carbamide Peroxide Mouthwash for Oral Wound Healing Postoperative Symptoms Xerostomia Relief and Oral Hygiene Following Diagnostic Biopsy of Minor Labial Salivary Glands for Sjögrens Syndrome Investigation
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
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:
The aim of this study is to evaluate the efficacy and safety of a carbamide peroxide mouthwash regarding oral wound healing postoperative symptoms xerostomia dry mouth and oral hygiene improvement Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögrens Syndrome following consultation with their rheumatologist This is a standardized diagnostic procedure that leads to healing by primary intention ie wound edges are closely re-approximated with sutures
Researchers are comparing this mouthwash with a placebo a look-and-taste-alike substance that contains no active ingredients to see if it is helpful with healing of wounds in the mouth and associated symptoms improving dry mouth andor oral hygiene Carbamide peroxide breaks down to hydrogen peroxide and urea and shows antiseptic and antimicrobial properties and it might help with the parameters to be assessed Participants randomly get the carbamide peroxide mouthwash or the placebo one to use for 14 days after the biopsy The investigators will not know which one they are providing as the bottles will be identical
Oral wound healing postoperative symptoms such as pain eating and speech difficulties oral hygiene dental plaque and gingival inflammation improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy Participants are required to visit the clinic three times one for the initial consultation and the biopsy one at 7 days and one at 14 days after the biopsy They are asked to fill in some questionnaires while certain procedures such as measuring saliva and assessments like evaluating the dental plaque and gingival inflammation take place During the first week they also keep a diary of their symptoms as instructed
Researchers are comparing this mouthwash with a placebo a look-and-taste-alike substance that contains no active ingredients to see if it is helpful with healing of wounds in the mouth and associated symptoms improving dry mouth andor oral hygiene Carbamide peroxide breaks down to hydrogen peroxide and urea and shows antiseptic and antimicrobial properties and it might help with the parameters to be assessed Participants randomly get the carbamide peroxide mouthwash or the placebo one to use for 14 days after the biopsy The investigators will not know which one they are providing as the bottles will be identical
Oral wound healing postoperative symptoms such as pain eating and speech difficulties oral hygiene dental plaque and gingival inflammation improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy Participants are required to visit the clinic three times one for the initial consultation and the biopsy one at 7 days and one at 14 days after the biopsy They are asked to fill in some questionnaires while certain procedures such as measuring saliva and assessments like evaluating the dental plaque and gingival inflammation take place During the first week they also keep a diary of their symptoms as instructed
Detailed Description:
This is a prospective randomized triple-blind placebo-controlled clinical trial and post-market clinical follow-up PMCF study expected to last approximately 12 months All proceduresvisitsexaminations are taking place in the Oral Medicine and Pathology Clinic at the School of Dentistry National and Kapodistrian University of Athens Greece Participants with reported dry mouth are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögrens Syndrome following consultation with their rheumatologist This is a standardized diagnostic procedure that leads to healing by primary intention After checking if they comply with the studys criteria they are informed about the study and the biopsy procedure including possible complications and they sign the Ιnformed Consent Form
All biopsies are obtained from the lower lip with a 12 - 15 mm linear incision After blunt dissection of the borders 5-7 lobules of minor salivary glands are removed by dissection with the scalpel or a curved mosquito forceps and the use of tweezers Attention is paid not to injure nerve branches or vessels Adequate hemostasis is achieved by manual pressure and the incision is closed by simple interrupted non-absorbable 40 silk sutures at equal distances Participants are instructed to have cold soft diet for the day and use ice packs externally for 1-2 hours after the procedure Use of 500mg paracetamol up to 3 times is permitted for day 0 Following their normal oral hygiene routine brushing and toothpaste is suggested
Subsequently they are assigned randomly in a 11 ratio to receive either a carbamide peroxide mouthwash or a placebo comparator ie a look-alike substance that lacks active ingredients Both participants and investigators are masked Follow-up examinations are conducted at 7 and 14 days On day 7 the sutures are cut
The evaluation includes
oral wound healing primary intention assessed by scores primary outcome
and secondarily
oral wound healing via measuring the incisionwound length
postoperative symptoms such as pain eating and speech difficulties
quality of life assessed by a questionnaire
improvement of dry mouth through subjective and objective measurements
oral hygiene via plaque and gingival indices
All data are anonymized and the outcome assessors are masked
The mouthwash used in the experinmentaltest group is a Class IIa CE-marked Conformité Européenne medical device This mouthwash contains hydrogen carbamide that breaks down to hydrogen peroxide and urea Hydrogen peroxide has antiseptic and antimicrobial properties as well the ability to mechanically clean affected areas by producing an oxygenated foam while urea shares antiseptic and antimicrobial abilities as well and can enhance the pH of the oral cavity These substances have been used in wound healing either in skin or intraorally as well as in oral hygiene for a long time However to date no clinical trial examining the use of a hydrogen carbamideperoxide product in oral wound healing postoperative symptoms or dry mouth has been reported Published clinical studies on the control of dental plaque and periodontal inflammation exhibit partially conflicting results
All biopsies are obtained from the lower lip with a 12 - 15 mm linear incision After blunt dissection of the borders 5-7 lobules of minor salivary glands are removed by dissection with the scalpel or a curved mosquito forceps and the use of tweezers Attention is paid not to injure nerve branches or vessels Adequate hemostasis is achieved by manual pressure and the incision is closed by simple interrupted non-absorbable 40 silk sutures at equal distances Participants are instructed to have cold soft diet for the day and use ice packs externally for 1-2 hours after the procedure Use of 500mg paracetamol up to 3 times is permitted for day 0 Following their normal oral hygiene routine brushing and toothpaste is suggested
Subsequently they are assigned randomly in a 11 ratio to receive either a carbamide peroxide mouthwash or a placebo comparator ie a look-alike substance that lacks active ingredients Both participants and investigators are masked Follow-up examinations are conducted at 7 and 14 days On day 7 the sutures are cut
The evaluation includes
oral wound healing primary intention assessed by scores primary outcome
and secondarily
oral wound healing via measuring the incisionwound length
postoperative symptoms such as pain eating and speech difficulties
quality of life assessed by a questionnaire
improvement of dry mouth through subjective and objective measurements
oral hygiene via plaque and gingival indices
All data are anonymized and the outcome assessors are masked
The mouthwash used in the experinmentaltest group is a Class IIa CE-marked Conformité Européenne medical device This mouthwash contains hydrogen carbamide that breaks down to hydrogen peroxide and urea Hydrogen peroxide has antiseptic and antimicrobial properties as well the ability to mechanically clean affected areas by producing an oxygenated foam while urea shares antiseptic and antimicrobial abilities as well and can enhance the pH of the oral cavity These substances have been used in wound healing either in skin or intraorally as well as in oral hygiene for a long time However to date no clinical trial examining the use of a hydrogen carbamideperoxide product in oral wound healing postoperative symptoms or dry mouth has been reported Published clinical studies on the control of dental plaque and periodontal inflammation exhibit partially conflicting results
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 75013022023 | OTHER | National and Kapodistrian University of Athens | None |