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Mucositis clinical trials

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NCT ID: NCT03693196 Completed - Peri-Implantitis Clinical Trials

The Effect of Different Dental Implant Surface Characteristics on Immunological and Microbiological Parameters

Start date: November 2016
Phase: N/A
Study type: Interventional

Objectives: To assess the levels of TNF-α, PGE2, RANKL, RANK, OPG, which are immunological markers of peri-implant disease and F. nucleatum, P. gingivalis, T. denticola, T. forsythia, P. intermedia, S. oralis, which are microbiological agents of peri-implantitis, in areas where SLA, fluorine-modified and anodized implant surfaces are used. Material and methods: In this study, 71 implants of 37 patients were assessed. The patients were grouped according to the surface characteristics of the implants. Group 1: SLA surface, Group 2: Fluorine modifying surface, Group 3:Anodization surface Plaque index (PI), gingival index (GI), bleeding on probing (BOP), pocket depths (PD), clinical attachment levels (CAL) and keratinized tissue width (KTW) were measured. Peri-implant sulcus fluid and subgingival plaque samples were collected. Results: PI was found to be significantly lowest in Group 1, higher in Group 3. Group 3 implants were found to have more bleeding on probing significantly. It was found to be higher peri-implant mucositis and peri-implantitis in Group 3. GI, PD, CAL, KTW were not found to differ between groups. No significant differences were found between TNF-α, PGE2, RANKL, RANK, OPG. While F. nucleatum, T. forsythia, T. denticola and P. intermedia were found to be significant highest in Group 3, P. gingivalis and S. oralis were found to be high in Group 2. Conclusion: Peri-implantitis rate, BOP and PI were found to be higher in Group 3. F. nucleatum, T. forsythia, T. denticola, and P. intermedia were found to be significantly high in Group 3 implants. This situation can be associated with the porous structure of anodized surface.

NCT ID: NCT03689712 Completed - Oral Mucositis Clinical Trials

ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

Start date: October 3, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

NCT ID: NCT03647527 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Predictor Analysis of Acute Radiation Oral Mucositis in NPC Patients Treated With IMRT/TOMO Combined Chemotherapy

Start date: September 1, 2016
Phase:
Study type: Observational

Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, single center, and exploratory study. Two contour methods of oral mucosal will be used in this study. All detail information will be recorded prospectively. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with new precise radiotherapy (intensity modulated radiotherapy or tomography radiotherapy) by using different dosimetric parameters and clinically relevant variables.

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: NCT03605186 Recruiting - Clinical trials for Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.

Start date: February 2019
Phase: N/A
Study type: Interventional

oral mucositis is a painful situation that significantly affects patients' quality of life with the severe cases being associated with ulcerated mucosa and secondary infection which may lead to life-threatening sepsis.Chamomile infusion in cryotherapy was used to aid in reduction of chemotherapy induced mucositis and to enhance the effect of standard cryotherapy alone by its anti-inflammatory, antifungal and antibacterial effect. The occurrence of oral mucositis is a significant complication of chemotherapy with prevalence of up to 80% in pediatric patients.The study is to be conducted at the in and outpatient clinics at the Department of Pediatric Oncology, National Cancer Institute,Egypt. A Structured interview questionnaire sheet will be filled with personal, medical and dental history. Intraoral examination will be carried out using sterile latex gloves, masks, plain mouth mirrors, sterile gauze and wooden tongue depressor. Patients who will agree to participate in the study will watch a video explaining how to perform oral hygiene.Preparation of the interventions is done in the clinic with 400 ml of distilled water with or without the infusion of 10 g of chamomile flowers."Chamomile classic infusion, Royal Herbs" .Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session. Follow ups are done at the 8th,15th and the 21st day of interventions application.

NCT ID: NCT03602066 Terminated - Clinical trials for Head and Neck Carcinoma

Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy

Start date: February 14, 2019
Phase: Phase 2
Study type: Interventional

This pilot randomized phase II trial studies who well chlorine dioxide sterilization works in reducing oral mucositis in patients with stage I-IV head and neck cancer who are undergoing radiotherapy. Chlorine dioxide sterilization may help to treat oral mucositis.

NCT ID: NCT03598881 Completed - Clinical trials for Mucosal Inflammation

A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation

Start date: September 19, 2016
Phase: N/A
Study type: Interventional

This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..

NCT ID: NCT03581773 Recruiting - Mucositis Clinical Trials

Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy

FASTERCC
Start date: December 20, 2017
Phase: Phase 2
Study type: Interventional

FASTERCC: Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. A randomized, double-blind trial from the Danish renal cancer group (DARENCA study-4)

NCT ID: NCT03577535 Completed - Mucositis Oral Clinical Trials

Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.

Start date: November 1, 2017
Phase: Phase 2
Study type: Interventional

Oral mucositis is one of the most spread side effects of anticancer therapy. It is associated with both chemo- and radiotherapy, decreases QoL, relative dose intensity and leads to nutritive deficiency. Oral mucositis causes secondary infections, increased hospital stay, whereas pain syndrome results in an emotional distress, anorexia and disables natural feeding.

NCT ID: NCT03575858 Withdrawn - Clinical trials for Dental Implants, Single-Tooth

The Effect of Different Shapes of Interdental Brushes in the Management of Peri-implant Mucositis and Gingivitis

Start date: December 15, 2018
Phase: N/A
Study type: Interventional

Rehabilitation of edentulous spaces with dental implants has become a routine treatment option as implants enjoy high survival rates over time. Accompanying this increase in implant use, epidemiological studies have also reported escalating incidences of peri-implant diseases. A recent meta-analysis reported that peri-implant mucositis and peri-implantitis had high estimated weighted mean prevalences of 43% and 22% respectively. It is common knowledge that gingivitis is the precursor of periodontitis. Similarly, peri-implant mucositis too precedes peri-implantitis, which is a very challenging condition to treat. Therefore, it is strongly recommended that peri-implant mucositis is managed effectively and in a timely manner. In order to reduce the inflammatory burden within the periodontium, mechanical plaque removal is of utmost importance. Mechanical debridement alone, without any adjunctive aids e.g. chlorhexidine, was found to be effective in preventing per-implant mucositis in short-term clinical trials but did not always result in complete resolution of inflammation (Heitz-Mayfield, et al. 2011, Schwarz, et al. 2015). Therefore, it can be speculated that patient administered home care may play a role in eliminating soft tissue inflammation over time. The study aims to investigate and compare the efficacy of the barrel shaped and tapered interdental brushes in reduction of soft tissue inflammation through removal of interproximal plaque at both tooth and implant sites in patients with moderately rough surface tissue level or bone level dental implants, which were restored with single screw or cement retained crowns and in function for the past 2- 5 years. The hypothesis of the study is that The barrel shaped interdental brush can remove more supra- and sub-gingival plaque and thus have more reduction in soft tissue inflammation, compared to the tapered interdental brush.