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Mucositis clinical trials

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NCT ID: NCT06137846 Enrolling by invitation - Clinical trials for Peri-implant Mucositis

Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy

Start date: October 31, 2023
Phase: N/A
Study type: Interventional

The investigators are evaluating the therapeutic outcomes of two cleaning instruments on treating peri-implant mucositis. Peri-implant mucositis is inflammation around an implant that is limited to only the gum tissue and is characterized by bleeding on probing, pus, and without any evidence of bone loss. The investigators wish to compare the amount of inflammation and bacteria through measurements (like probing depth) and by collecting fluid and plaque samples around participants' implant after using one of the two cleaning instruments.

NCT ID: NCT06122636 Enrolling by invitation - Quality of Life Clinical Trials

Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

The study is a Clinical Trial and the main objective is to Evaluate the effects of probiotics on oral complications induced by antineoplastic therapies in patients with head and neck cancer, attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), Faculty of Medicine and Health Sciences Bellvitge campus during the period 2022- 2024. Research question: Is the use of probiotics compared to placebo effective in reducing oral complications produced by antineoplastic therapies in patients with head and neck cancer attended in the radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet and the Dental Hospital of the University of Barcelona, Faculty of Medicine and Health Sciences campus Bellvitge during the period 2022- 2024? Study population: Patients attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), (Master of Dentistry in Oncology and Immunocompromised Patients) diagnosed by histological confirmation of head and neck cancer and treated in the last year.Intervention: Patients who agree to participate in the study will be randomized to the intervention or control group. Two visits will be made, the first as a baseline measurement and the second after the end of the intervention. In the first visit they will be given the products either probiotic or placebo, with presentation of a box with 10 sachets. The probiotics contain: Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus. 1 x 10e10 Colony Forming Units (CFU). And the placebo composed of excipients. They are gluten free. Each patient will be given 1 sachet dissolved in water, to take 2-3 minutes of mouthfuls then swallow, after brushing, once a day, for 30 days.

NCT ID: NCT06063876 Enrolling by invitation - Peri-Implantitis Clinical Trials

Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty

Start date: September 5, 2023
Phase: N/A
Study type: Interventional

This controlled clinical trial will assess clinically, immunologically, and microbiologically the healing of experimental peri-implant mucositis (PIM) lesions in implants treated previously with implantoplasty (IP) compared to those treated without IP.

NCT ID: NCT05675241 Enrolling by invitation - Peri-Implantitis Clinical Trials

Characterizing the Inflammation Around Dental Implants

Start date: September 1, 2022
Phase:
Study type: Observational

The use of titanium dental implants has become a common modern treatment to restore teeth. Although the success rate of dental implants is high, inflammation around the dental implant still occurs. The current study will investigate if the inflammation around the implant is due to bacterial infection, hypersensitivity or both. The goal of this cross-sectional study is to (1) Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection and hypersensitivity reaction; (2) Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis); (3) Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.

NCT ID: NCT05590117 Enrolling by invitation - Colo-rectal Cancer Clinical Trials

Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal Cancer

Start date: October 11, 2022
Phase: Early Phase 1
Study type: Interventional

This study aims to: - Evaluate the possible protective effect of pentoxifylline against oxaliplatin induced peripheral neuropathy and chemotherapy induced mucositis in patients with stage II and stage III colorectal cancer. This study will be a randomized placebo controlled parallel study.48 patients with colorectal cancer will be randomized to 2 groups: Group I (control group; n=24) which will receive 12 cycles of FOLFOX-6 regimen plus placebo tablets twice daily. Group II (Pentoxiphylline group; n=24) which will receive FOLFOX-6 regimen in addition to pentoxifylline 400 mg twice daily. Blood sample collection and biochemical assessment: - Malondialdehyde (MDA) as oxidative stress marker (colorimetry). - Tumor necrosis factor alfa (TNF-α) as pro inflammatory marker (ELISA). - Neurotensin (NT) as a potential marker for neuropathic pain (ELISA). - Citrulline as a biomarker for mucositis (ELISA). Clinical assessment of oxaliplatin induced neuropathy will be done through: The assessment of the severity of neuropathic pain through "Brief Pain Inventory-Short Form" at baseline and by the end of every two chemotherapy cycles. The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy every 2 cycles. The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group at baseline and by the end of every two chemotherapy cycles). Mucositis will be assessed at baseline and by the end of every two chemotherapy cycles through the use of common terminology criteria for adverse events "CTCAE, version 5.00, 2017

NCT ID: NCT05438771 Enrolling by invitation - Colon Cancer Clinical Trials

The Effects of Ankaferd Blood Stopper

ABS
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The purpose of oral care is to reduce the effect of oral pathological microbial flora and to prevent infection, pain, and bleeding associated with cancer treatment. New agents are introduced each day to be used in the prevention and treatment of mucositis in cancer treatment. One of those agents is the Ankaferd Hemostat. Ankaferd Hemostat has pleiotropic effects and anti-infective characteristics in tissue healing. The aim of this study is to evaluate the effectiveness of the Ankaferd Hemostat in the prevention of oral mucositis due to chemotherapy in adult patients diagnosed with colorectal cancer. The study was designed as a randomized controlled experimental study to be conducted with patients who are recently diagnosed with colorectal cancer and will receive the first course of chemotherapyd. The data were collected using the Performance Score and the Oral Mucositis Evaluation Scale.

NCT ID: NCT05338398 Enrolling by invitation - Oral Mucositis Clinical Trials

Study for the Prevention of Oral Mucositis (SPOM)

SPOM
Start date: April 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

1. Study Design - Prospective, Randomized, Questionnaire-Based Study - Study Type: Phase 1/Phase 2 Interventional Clinical Trial - Intervention Model: Parallel Assignment - Masking: None (Open-label) - Actual Enrollment: 100 participants - Allocation: Randomized - Primary Purpose: Supportive Care/Treatment - Study groups - Control Group (Group 1): Saline mouthwash (±Bocaliner™) - Intervention Group (Group 2): Benzydamine mouthwash (±Bocaliner™) 2. Settings - Single-center (a specialized hematology center) - Location: Hematology Center after Prof. R. Yeolyan, 7 Nersisyan St, Yerevan 0014, Armenia - Subjects will initially be enrolled, consented, examined, and complete initial questionnaires in the healthcare provider's office Subjects will undergo initial evaluation and follow-up examinations to determine WHO Oral Mucositis Scores - Subjects will complete questionnaires at the medical center with the Research Coordinator 7 and 14 days after study enrollment. Subjects using Bocaliner™ will additionally complete a follow-up questionnaire. - Application of Bocaliner™ will be carried out first at the hospital followed by self-administration at home.

NCT ID: NCT03613389 Enrolling by invitation - Clinical trials for Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Prevention of Oral Mucositis After Using Oral Topical Vitamin E Versus Voriconazole and Levofloxacin in Pediatric Cancer Patients Receiving Chemotherapy

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Statement of problem Oral mucositis is an inflammatory condition that affects mucosa of the oral cavity. The etiology of this kind of aggravation is related to the introduction of radiotherapy or chemotherapeutic medications. (Alvarino et al., 2014, Rohani et al., 2015) With the prevalence of mucositis up to 80% in pediatric patient (Cheng et al., 2004). Clinically, oral mucositis is a painful situation that significantly affects patients' quality of life. The severe cases are associated with ulcerated mucosa and secondary infection which may led to life-threatening sepsis. (Kolokythas , et al., 2010) Oral mucositis is one of the most debilitating complications following chemotherapy, its remains an unresolved clinical problem, and it has physical and psychosocial implications for patients. The ulcerative lesions are often very painful, requiring treatment with analgesics and supportive nutrition, and the cancer treatment may need to be interrupted or modified. All these conditions may increase treatment costs, preclude further treatment and alter the quality of life of the patient. (Sonis et al., 2001) There are many oral care regimens including prophylactic antibacterial and antifungal drugs, Levofloxacin is antibacterial drug causing inhibition of cell wall synthesis agent, Levofloxacin failed to show any significant difference in mucositis or oral ulceration (Bucaneve et al., 2005). While voriconazole is antifungal that has been noted to cause transient visual disturbances and A major drawback is potential interactions with certain chemotherapy agents (Marks et al., 2011). Vitamin E is an antioxidant agent which may limit tissue damage from free oxygen radicals and, thus, may reduce the severity of mucositis during cancer treatments and protect cell membranes from radiation damage (Alterio et al., 2007). It has a very low toxicity and is generally well-tolerated (Geeraert et al., 2015). Rationale There is no enough studies about vitamin E effect in reduction of oral mucositis. El -Housseiny et al., (2007), recommend that oral mucositis is successfully treated by the topical application of vitamin "E", compared to its systemic administration. Vitamin "E" alone is not enough for the treatment of infected lesions; further studies using vitamin "E" to treat the infected lesions are needed. Also based on the recommendation of Wadleigh et al., (1992) who was the first one to study the topical effect of vitamin "E" on oral mucositis; however, they did not know whether the effect was due to the topical application or the systemic absorption of the vitamin when applied topically. Benefit to patient and population: The vitamin E is nontoxic, odorless, tasteless, and well tolerated by the patients, reduce nutritional compromise, maintain impact on quality of life, and reasonable economic costs. Benefits of practitioners and clinicians: The use of vitamin E is easy to apply, not technique sensitive and it is cheap and readily available reducing clinical time.

NCT ID: NCT02662374 Enrolling by invitation - Oral Mucositis Clinical Trials

Oral Hygiene Regimen in Patients on HCT

Start date: September 2015
Phase: Phase 4
Study type: Interventional

Oral mucositis is one of the most common debilitating forms of mucositis that arise from high dose chemotherapy and radiotherapy. It is reported that almost 75% patients undergoing hematopoietic cell transplantation (HCT) develop oral mucositis at different levels of severity. The objective of this prospective study was to assess the efficacy of the addition of supersaturated calcium phosphate oral spray and the addition of an extra soft tooth brush to the basic OH in addition to the currently existing oral hygiene protocol regimen (0.2% Chlorhexidine Gluconate + 3% Sodium Bicarbonate+ Nystatin 100000 U/ml) in reducing the severity of oral mucositis among patients receiving chemotherapy for HCT. 60 patients receiving chemotherapy for HCT were randomly allocated to four groups of 15 patients each The oral mucositis was recorded according to WHO criteria and the progression of the oral mucositis was monitored from the day of admission (day - 1) to the day of discharge (day 28). The absolute neutrophil count, platelet counts and salivary flow rate of all patients was recorded.

NCT ID: NCT02020928 Enrolling by invitation - Oral Mucositis Clinical Trials

Laser Therapy Prevents Mucositis Oral in Chemotherapy for Bone Marrow Transplantation?

lasertherapy
Start date: January 2015
Phase: Phase 3
Study type: Interventional

Setting: Oral mucositis is a very common complication of cancer treatment, accounting, often at increased risk for infections and even the interruption of treatment, interfering with the prognosis of the disease. The low intensity laser therapy has been proposed as an alternative for the treatment and prevention of this side effect, with good results in terms of clinical and functional, speeding up the process of wound healing and reducing pain. Objective: To evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation. Methods: There will be a Clinical Trial Randomized, double-blind study to evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation. Participate in the study, patients who are in the condition mentioned above accepting participate and have aged over 18. Will be excluded from the study patients who have autoimmune disease, which present sensitivity to laser or who have already started treatment for oral mucositis prior to this study.The study variables are:-independent variable: whether or not the red laser of low power-dependent variables: oral mucositis, degree of mucositis, chemotherapy regimen, type of blood cancer. For determining the association between the independent variable and the dependent will be used chi-square tests of association (Pearson) and Fisher's exact test, if necessary. Will calculate the risk ratio (RR) as a measure of relative risk, with the confidence interval at 95% (IC95%).Also be calculated NNT (number needed to treat to obtain benefit) and NNH (number needed to harm getting). Will be adopted a significance level of 5%. The project was approved by the Ethics and Research iMIP. All patients will be appropriately informed about the objectives of the project and will only be included if they voluntarily agree to participate by signing the consent form. Keywords: laser, prevention and control; oral mucositis, bone marrow transplant.