Canker Sore (Aphthous Ulcer)

Researchers are evaluating noninvasive imaging methods to study the appearance of skin and mucosal lesions to improve diagnostic accuracy before a biopsy is needed and to help guide treatment planning. This study involves creating an Image Repository to store these images for clinical practice, teaching, training, and future research. It uses a high-resolution Optical Coherence Tomography OCT device called ApolloVueae S100 Image System that provides detailed cross-sectional and en-face images with cellular information. Participants with muco-cutaneous lesions, including normal skin, benign lesions, or neoplastic conditions, identified during routine clinical care will undergo various non-invasive imaging tests. These include dermoscopic imaging, 3-dimensional total body photography, confocal microscopy, OCT imaging, ultrasound, hyperspectral imaging, electrical impedance spectroscopy, and patient self-imaging using mobile phone technology with dermatoscope attachments. Images will be collected of untreated and treated lesions over a period of 7 years. Participants will have their lesions imaged using these non-invasive tools, with images collected and stored in the Image Repository. Assessments include capturing detailed images using specialized devices to evaluate lesion morphology, depth, vascular features, and biochemical information. Researchers will monitor the imaging data to support clinical decisions, teaching, and future research. Participation may involve multiple imaging sessions over time, and safety monitoring includes ensuring no allergic reactions to imaging materials. The study welcomes healthy volunteers and all ages, with informed consent or parental consent and patient assent as applicable.

Researchers are investigating oral disorders in extremely premature infants born before 29 weeks, focusing on the age at which these infants achieve full oral feeding without the need for tube feeding. The study aims to understand the development of oral skills in this population, as oral disorders can lead to delayed feeding autonomy and longer hospital stays, impacting psychomotor and cognitive development. It also seeks to identify risk factors for delayed oral feeding and calculate the incidence of oral feeding disorders up to 24 months of age. The study monitors infants admitted to a neonatal unit where a daily tactile stimulation protocol of orality is applied by nurses and physiotherapists to support the development of oral skills. This protocol involves stroking cheeks and peri-oral and intra-oral areas to encourage oral feeding autonomy. The study is observational and focuses on infants born between 2018 and 2021 who received this care approach during their hospital stay. Participants will be followed from birth until they reach full oral feeding autonomy, with the main measurement being the corrected gestational age at this time, observed up to two months. Researchers will also analyze risk factors for delayed oral feeding and track oral feeding disorders over a longer term. Data collection includes monitoring feeding progress and hospital discharge details, with participant involvement ending when oral feeding autonomy is achieved or after 24 months for disorder incidence assessment.

The trial investigates whether a single intravenous infusion of Amimestrocel injection, a cell therapy made from human umbilical cord mesenchymal stem cells, can help reduce severe mouth sores called oral mucositis in adults undergoing myeloablative allogeneic hematopoietic stem cell transplantation HSCT. This painful side effect commonly occurs due to strong chemotherapy regimens containing total body irradiation TBI andor melphalan. The study is a Phase 2, single-center, open-label exploratory trial involving about 22 adult patients aged 18 to 65 years. Participants will receive a single fixed dose of Amimestrocel injection 6.0 107 cells in 12 mL intravenously within 24 to 48 hours after the last dose of cyclophosphamide, which is part of the standard conditioning regimen, and before the stem cell infusion Day 0. All patients will also undergo standard myeloablative conditioning containing TBI andor melphalan, followed by allogeneic stem cell transplantation and standard supportive care. During the study, patients will be closely monitored daily for the presence and severity of oral mucositis and pain for 28 days after transplant. Researchers will assess pain levels, opioid use, diarrhea, and time until blood counts recover. Safety will be followed for 100 days post-transplant, including adverse events and serious adverse events. The main outcome is the incidence of severe Grade 3-4 oral mucositis within 28 days after transplant.

Researchers are evaluating the use of dexamethasone mouthwash as a preventive treatment for stomatitis related to Datopotamab Deruxtecan Dato-DXd in patients with metastatic or inoperable locally recurrent breast cancer or advanced or metastatic EGFR-mutated non-small cell lung cancer. This Phase IV, open-label, single-arm study aims to describe how often and how severe grade 2 or higher stomatitis occurs in participants receiving this prophylactic mouthwash during the first 12 weeks of Dato-DXd treatment. Participants will receive dexamethasone 0.5 mg5 mL alcohol-free mouthwash, swishing 10 mL four times daily for about 2 minutes and then spitting it out without swallowing. They must avoid food or drink for at least 30 minutes after use. This mouthwash will be used throughout their standard care treatment with Dato-DXd. The study includes two groups one with breast cancer and one with lung cancer patients, enrolling about 100 participants total over 18 months. During the study, participants will be monitored for stomatitis incidence and severity up to 12 weeks after starting treatment, with additional assessments up to about 21 months for onset and resolution timing. Researchers will also track adherence to the mouthwash, any dose changes in Dato-DXd due to stomatitis, and overall safety. Follow-up for safety continues for 28 days after the last study dose, with various evaluations including clinical assessments throughout the treatment period.

This research aims to understand how inflammation in the mouth affects the immune response during wound healing after tooth extraction. The study involves healthy adults aged 21 to 70 who need a posterior tooth extracted. Researchers will measure periodontal inflammation and take dental X-rays before the extraction to gather baseline information. Participants will undergo an atraumatic extraction of the affected tooth using local anesthesia. Small soft tissue biopsies from the extraction site will be collected immediately after extraction and again two weeks later when sutures are removed. A final visit at three months post-extraction will include clinical assessments and dental X-rays to evaluate healing. Throughout the study, researchers will collect data such as probing depths, gum recession, bleeding, and fluid samples from adjacent teeth. The soft tissue samples will be analyzed to count inflammatory cells and study immune activity during healing. Participants will be involved in three main visits over about three months, with careful monitoring of healing and inflammation.

Researchers are evaluating the effectiveness of an antioxidant mouthwash containing resveratrol in reducing oral malodor bad breath and the bacteria Porphyromonas gingivalis among undergraduate dental students with plaque-induced gingivitis. The study also aims to explore the relationship between this bacteria and clinical gum health measures such as plaque index, gingival index, and bleeding on probing. This is a randomized, triple-blind clinical trial involving students aged 20 to 23 without systemic diseases or recent periodontal treatment. Participants will be divided into three groups of 18 each. One group will use the resveratrol mouthwash, the second group will use chlorhexidine mouthwash as an active comparator, and the third will use distilled water as a placebo. All will rinse twice daily with 10 ml of the assigned mouthwash for 30 seconds, after brushing their teeth, over a 7-day period. They will be reminded twice daily by text message to maintain compliance and instructed to avoid eating or drinking for 30 minutes after rinsing. During the study, participants will complete questionnaires covering personal information, oral hygiene habits, and perceptions of oral malodor. Clinical assessments will include plaque index, gingival index, bleeding on probing, and organoleptic odor tests of the tongue and interdental areas. A portable sulfide monitor will confirm halitosis levels. These measures will be recorded at baseline and after 7 days of mouthwash use. Participants will also provide feedback on mouthwash taste and sensations using a visual scale. Safety monitoring includes advice to stop use if allergic reactions occur.

Researchers are evaluating the STRATICYTE12 predictive model to see how well it can predict the transformation of oral potentially malignant disorders OPMDs into oral squamous cell carcinoma OSCC. This study focuses on a retrospective group of patients who had biopsies taken for oral lesions. The main goals include assessing the models sensitivity and specificity, understanding which patient and clinical factors affect its accuracy, and estimating how STRATICYTE12 results relate to the time until a positive oral cancer diagnosis. The study involves analyzing biopsy tissue samples from patients with various grades of oral epithelial dysplasia, including no dysplasia, mild, moderate, severe dysplasia, and carcinoma in situ CIS. Participants are grouped based on whether their OPMDs progressed to OSCC or not. STRATICYTE12 testing is used to assess the risk of progression to oral cancer by reviewing archived biopsy tissue blocks from clinical centers. Participants archived biopsy data and clinical follow-up records over at least five years are reviewed. Researchers measure the STRATICYTE12 tests sensitivity, specificity, area under the curve AUC, and Harrells C-index, along with survival analysis over five years. The study tracks the correlation of STRATICYTE12 outcomes with oral cancer development timing. No new treatments or procedures are performed during this observational study, and the overall participation involves data analysis from past biopsies and clinical records.

Researchers are evaluating the safety of using the galea and pericranium fascio-periosteal temporal flap for reconstructing mandibular gingival defects. This approach aims to improve function and appearance after surgical removal of oral cavity tumors. The study builds on previous experiences where similar flaps have been used successfully for head and neck reconstruction, including bone regeneration and treatment of pharyngeal fistulas. The study involves patients who need reconstruction following partial removal of the mandibular gingival region. Surgeons will use periosteum, galea, or pericranium flaps harvested from the cranial temporal region, which has good blood supply, to repair soft and hard tissue defects. This method is being assessed as a reliable option for oral cavity reconstruction after tumor excision. Participants will be followed for at least 18 months to monitor outcomes. Researchers will evaluate the function and safety of the flap reconstruction, including bone and tissue healing. Patients will have regular follow-up visits for assessments, and their progress will be closely monitored to measure the success of the surgical procedure and any related complications.

Researchers are evaluating whether taking folic acid supplements can help reduce mucositis, which includes inflammation and soreness in areas like the nose, mouth, throat, anus, or genital area, in patients with metastatic renal cell carcinoma mRCC who are receiving targeted treatments such as tyrosine kinase inhibitors TKI, immunotherapy, or mTOR inhibitors. This is a randomized, double-blind, placebo-controlled phase II study conducted by the Danish Renal Cancer Group to compare folic acid versus placebo for treating mucositis. Participants will be randomly assigned to one of two groups one group will receive a daily 5 mg folic acid tablet for 12 weeks, and the other will receive a placebo tablet daily for the same period. Both groups will continue to receive the best supportive care for their cancer and mucositis symptoms. No crossover between groups will be allowed during the study. The study plans to enroll about 100 patients over 96 months, with block randomization based on the type of cancer treatment patients are receiving. During the trial, participants will be monitored for mucositis severity using the Common Terminology Criteria for Adverse Events CTCAE over 16 weeks. Additional assessments include patient-reported mucositis frequency and severity, time to treatment effect, treatment dose reductions or discontinuations, gastrointestinal and skin-related side effects, and quality of life measures. Safety monitoring and adherence to the study drug will be conducted throughout the study duration.

Researchers are evaluating whether multiple sessions of photobiostimulation using an Nd-YAG laser can improve healing after tooth extraction and alveolar ridge preservation. This study aims to measure the effects of laser treatment on wound healing by examining saliva markers, tracking changes in gingival wound size, and assessing post-operative pain and patient satisfaction. The research focuses on enhancing recovery and comfort following dental surgery. Participants will be divided into two groups one receiving standard tooth extraction and alveolar ridge preservation with sham laser control group, and the other receiving the same procedure combined with Nd-YAG laser photobiostimulation on days 1, 3, and 7 after surgery. The laser will be applied using a LightWalker device with specific settings, and both participants and operators will wear protective glasses during treatments. During the study, participants will have their saliva tested for inflammation markers from the day of surgery through day 7. Wound size changes will be monitored up to day 42, and pain levels will be recorded from day 3 to day 14 after surgery. Researchers will also survey patients about pain relief and satisfaction. The total participation period may last up to 42 days, including follow-up assessments to observe healing progress and safety.