Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370260
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-13
Brief Title:
Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene
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 Hydrogen Peroxide Gel UNISEPTORAL GEL for Oral Wound Healing Postoperative Symptoms and Oral Hygiene in Patients Undergoing Incisional or Excisional Punch Biopsy of Gingival or Palatal Oral Mucosa
Status:
COMPLETED
Status Verified Date:
2024-04
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:
This study aims to assess the effectiveness and safety of a hydrogen carbamideperoxide gel called UNISEPT ORAL GEL in promoting oral wound healing alleviating postoperative symptoms and enhancing oral hygiene
Study participants will include individuals with any suspicious lesion in their gums or the roof of their mouth They will undergo a procedure to remove a small piece of tissue for testing biopsy in order to confirm the diagnosisThis is a standardized diagnostic procedure that involves the use of a punch which is a plastic handpiece with a cylindrical cutting blade Subsequently the wound heals naturally without the need for sutures
Researchers are comparing this gel 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 oral hygiene Participants randomly get the hydrogen carbamideperoxide gel or the placebo one to use for 14 days after the biopsy The researchers will not know which one they are providing as the gel tubes will be identical
Oral wound healing postoperative symptoms such as pain eating and speech difficulties oral hygiene dental plaque and gingival inflammation 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 biopsy one at 7 days and one at 14 days after the biopsy They are asked to fill in some questionnaires while certain procedures taking a photo the site of the biopsy 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
Study participants will include individuals with any suspicious lesion in their gums or the roof of their mouth They will undergo a procedure to remove a small piece of tissue for testing biopsy in order to confirm the diagnosisThis is a standardized diagnostic procedure that involves the use of a punch which is a plastic handpiece with a cylindrical cutting blade Subsequently the wound heals naturally without the need for sutures
Researchers are comparing this gel 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 oral hygiene Participants randomly get the hydrogen carbamideperoxide gel or the placebo one to use for 14 days after the biopsy The researchers will not know which one they are providing as the gel tubes will be identical
Oral wound healing postoperative symptoms such as pain eating and speech difficulties oral hygiene dental plaque and gingival inflammation 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 biopsy one at 7 days and one at 14 days after the biopsy They are asked to fill in some questionnaires while certain procedures taking a photo the site of the biopsy 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 women or men with any lesion in the gingiva or the palate potentially malignant disorders pigmented lesions soft tissue masses that require an incisional or excisional biopsy following histopathological examination can be enrolled after checking if they comply with the studys criteria Then they are informed about the study and the biopsy procedure and they sign the Ιnformed Consent Form
All biopsies are obtained from the gingiva or hard palate with a sterile disposable or reusable punch of 46 or 8mm in diameter resulting in the extraction of similar tissue cylindersThe punch is grasped between the index and thumb supporting the cylinder over the target lesion Healing by secondary intention follows as suturing of the residual wound is not necessary and the bleeding can be contained by simply applying a piece of gauze
Participants are instructed to have cold and soft diet for the day 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 hydrogen carbamideperoxide gel UNISEPT ORAL GEL - Intermed SA and Ioulia And Irene Tseti Pharmaceutical Laboratories SA or a placebo comparator ie a look-alike substance that lacks active ingredients such as hydrogen carbamideperoxide Both participants and investigators are masked Follow-up examinations are conducted at 7 and 14 days
The evaluation includes
oral wound healing secondary intention assessed by percentage healing index PHIprimary outcome
and secondary outcomes oral wound healing assessed by clinical parameters such as redness oidema pus discharge postoperative symptoms such as pain eating and speech difficulties quality of life assessed by a questionnaire oral hygiene via plaque and gingival indices
All data are anonymized and the outcome assessors are masked
UNISEPT ORAL GEL is a Class IIa CE-marked Conformité Européenne medical device This gel contains hydrogen carbamide that breaks down to hydrogen peroxide which has antiseptic and antimicrobial properties 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 there is no clinical trial examining the use of a hydrogen carbamideperoxide product in oral wound healing and postoperative symptoms Published clinical studies on the control of dental plaque and periodontal inflammation exhibit partially conflicting results
All biopsies are obtained from the gingiva or hard palate with a sterile disposable or reusable punch of 46 or 8mm in diameter resulting in the extraction of similar tissue cylindersThe punch is grasped between the index and thumb supporting the cylinder over the target lesion Healing by secondary intention follows as suturing of the residual wound is not necessary and the bleeding can be contained by simply applying a piece of gauze
Participants are instructed to have cold and soft diet for the day 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 hydrogen carbamideperoxide gel UNISEPT ORAL GEL - Intermed SA and Ioulia And Irene Tseti Pharmaceutical Laboratories SA or a placebo comparator ie a look-alike substance that lacks active ingredients such as hydrogen carbamideperoxide Both participants and investigators are masked Follow-up examinations are conducted at 7 and 14 days
The evaluation includes
oral wound healing secondary intention assessed by percentage healing index PHIprimary outcome
and secondary outcomes oral wound healing assessed by clinical parameters such as redness oidema pus discharge postoperative symptoms such as pain eating and speech difficulties quality of life assessed by a questionnaire oral hygiene via plaque and gingival indices
All data are anonymized and the outcome assessors are masked
UNISEPT ORAL GEL is a Class IIa CE-marked Conformité Européenne medical device This gel contains hydrogen carbamide that breaks down to hydrogen peroxide which has antiseptic and antimicrobial properties 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 there is no clinical trial examining the use of a hydrogen carbamideperoxide product in oral wound healing and postoperative symptoms 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 |
|---|---|---|---|
| 57113022023 | OTHER | INTERMED SA | None |