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26 active trials for Gingivitis

A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis

The aim of this study is to develop a daily use toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride with the intention of providing improved/ fast gum healing. This Proof-of-Principle study will investigate the efficacy of an experimental dentifrice compared to a regular fluoride dentifrice, and also whether this provides any additional benefit in reducing gingival inflammation/ bleeding compared with a 67% w/w sodium bicarbonate/ 0.221% w/w sodium fluoride containing toothpaste.

Start: February 2021

Artificial Intelligence Evaluation of Periodontal Health Using Selfie Intraoral Photography

Periodontal (gum) disease affecting more than 90% of the population globally. The soft and hard tissues that supporting the teeth are being affected. If untreated, the disease progresses from the mild and reversible form (i.e. gingivitis) that involves superficial gum only to the more severe and irreversible form (i.e. periodontitis) that involves loss of periodontal ligament and bone. Teeth will be lost eventually and significantly impairs the function and the oral health related quality of health. Moreover, periodontal disease has been strongly linked to the systemic diseases via centrally or local routes with significant health implications. Periodontal disease is initiated by bacteria (plaque) adhere on tooth surfaces and the body defense by eliciting inflammatory response. The disease and associated inflammation is site-specific and the affected gum is manifested with the cardinal signs of inflammation such as redness (color), swelling (increased volume), edema (loss of surface characteristics) and bleeds easily. Dentists are trained to identify the disease sites by visual (redness and swelling) and by mechanical probing (bleeding). Traditionally these give rises to clinical gum indices showing the degree of inflammation and are important to the clinical monitoring and management of gum diseases. The management of periodontal disease involves the removal of bacteria plaque by both dentists' tooth cleaning and maintained by patients' daily home-care. Home-care plaque removal has been shown by many studies to prevent and/or cease the development of periodontitis. However, most patients do not able to remove plaque effectively and it only takes few days for a health site to development inflammation. Professional monitoring and feedback are highly desirable but many patients only have monthly or even yearly appointment which is too late. Such "non-compliance" increase the treatment cost/time, patient discomfort and reduce treatment efficacy. Moreover, many patients do not receive regular dental checkup and they seek dentists when the gum problem becomes irreversible that complicated and expensive treatment such as tooth extraction and rehabilitation is required. This study consists of 1) collecting the standardized clinical photography with clinical gum indices/ marked by an experienced clinician, 2) import into computer for training, and 3) longitudinally monitoring and analyze of gum condition in a group of gingivitis patients receiving gum treatment.

Start: January 2022

Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)

Treated hypertensive patients with any form of periodontal diseases will be randomized to either supragingival dental plaque removal using electric toothbrushes at home or intensive professional oral hygiene treatment and the effects on blood pressure will be identified.

Start: June 2024

Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances

Start: September 2021

(NOD)-Like Receptors CARD Domain-Containing 4 Levels in Individuals With Periodontitis

NLRC4, an inflammasome , is a cytosolic multiprotein complex involved in the initiation and modulation of the immune response. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. The authors think that NLRC4 may play a role in the periodontitis. The aim of this study is to compare the NLRC4, IL-1? and IL-10 levels of healthy and periodontitis individuals.

Start: April 2021

Shifts in the Oral Biofilm of Patients With Known Oral Health Risk Factors

This study is observational only and is intended to evaluate changes in the makeup and function of bacteria naturally present in the mouth during treatment with braces to straighten teeth.

Start: August 2016

Meteorin-like Levels in Individuals With Periodontitis

Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl is highly expressed from the oral mucosa to the esophagus. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. The authors think that Metrnl may play a role in the periodontitis. The aim of this study is to compare the Metrnl, TNF-?, IL-1?, TGF-?, IL-10 and VEGF levels of healthy and periodontitis individuals.

Start: February 2020

Evaluation of Toothbrush Bristles in Plaque Reduction

The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods. This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.

Start: April 2021

Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine Delivery Systems

Although the well-known detrimental effects of conventional cigarette smoking on oral health, there are still lack of evidences about the impact of less harmful alternatives (such as electronic cigarettes or heat not burn products), especially in young smokers with clinical absence of signs of moderate to severe periodontitis. This study aims to investigate whether cigarette smokers who switch to combustion-free nicotine delivery systems (C-F NDS) undergo measurable improvements in oral health parameters and teeth appearance, comparing short- and long-term impact on periodontal health between smokers continuing with conventional cigarette smoking, those switching to combustion-free nicotine delivery systems (C-F NDS), and never-smokers. The investigator propose a prospective, multicenter, interventional, open label, randomized, controlled, three parallel-arms study assessing oral health parameters and teeth appearance of 18 months duration.

Start: February 2021

Effects Of Low Level Laser Therapy On Tooth Movement,Treatment Related Complications Of Gingivitis,Periodontitis And Pain In Fixed Orthodontic Patients

INTRODUCTION Orthodontic treatment objectives are achieved through the movement of teeth with the application of an external physical force. It takes around 2 to 3 years to finish the treatment.The most common complications associated with orthodontic treatment are Pain Prolonged duration Gingival and Periodontal complications So orthodontists, clinicians and researchers are always looking for some non-invasive and reliable techniques to minimize the possibility of occurrence of these complications. General objective The prime aim of this research is to study the effect of LLLT on tooth movement,pain, gingival and periodontal complications associated with tooth movement in initial phase of orthodontic treatment. Design of study This will be an experimental; case controlled study utilizing Low Level Laser Therapy in arch form of application.Anterior teeth segment of the maxillary jaw will be treated with LLLT in one group and other group of patients considered as control. Study population and samples This research will be conducted among Pakistani subjects who will be going for fix orthodontic treatment. Research subjects will be gathered from Aga Khan Hospital for Women Karimabad A secondary hospital of Aga Khan University Hospital of Karachi Pakistan. The duration of the study will be six months in which each patient will avail their regular follow up orthodontic treatment visits at every three weeks LLLT will be applied at every visit i.e. 0, 1, 2, 3, 4, 5 and 6th visits on anterior segment of the maxillary jaw in one group of patients, while the other group of patients will be controlled. The clinical parameters gingival index (GI), Bleeding on Probing (BOP), Probing Depth (PD) and clinical attachment loss (CAL) for the research will be recorded at 0, first, third and sixth visit. Study models to determine tooth movement will be taken in all visits from 0 to 6th visit. A Per forma to record the level of pain has been designed which will be given to all the patients at 0 to sixth all visits to record the pain intensity. Data will be recorded simultaneously. Sample frame The sample frame of patient recruitment for this research will be consisting of patients who will sign consent for this research and fulfill the inclusion and exclusion criteria. Sample size will be comprised of 88 pre-orthodontic patients, with an age range of 18 to 30 years. Sample size calculation Sample size will be determined by using PS software (version 3.1.2). To avoid individual variations, the patients will be divided into two groups randomly, using computer generated random numbers. Microsoft Excel 2013 will be used for group randomization. Group A and B will comprise of 36 patients (18 males and 18 females in each group) respectively and only Group A will receive LLLT on anterior segment of the maxillary jaw. However 20% drop out is considered which makes the sample size of 44 in each group at the beginning of study. Research tool The duration of the study will be 6 months in which each patient will visit on their regular follow up orthodontic treatment visits at every 3 weeks. LLLT will be applied at every visit i.e. 0, 1, 2, 3, 4, 5 and 6 months in patients of Group A. The clinical parameters Gingival Index, Bleeding on Probing (BOP), Probing Depth (PD) and Clinical Attachment Loss (CAL) for the research will be as recorded at 0, first, third and sixth visit of all patients of both groups. Conclusion The benefits of adopting LLLT (Low Level Laser Therapy) in an arch form in a routine orthodontic practice may enhance the rate of tooth movement, may be helpful to control orthodontic treatment related complications like pain, gingivitis and periodontitis with comfort and without disturbing patient regular recall visits.

Start: July 2021

Effectiveness of Salvadora Persica Miswak in Improving Plaque Control and Gingival Health

Dental plaque is a main etiologic agent in periodontal disease. Global of Burden Disease Study 2016 ranked periodontal disease as the 11th most prevalent disease affecting 10.5% population worldwide. Tooth brushing is a reliable mechanical means to control dental plaque accumulation in order to maintain oral health. For decades, studies have demonstrated the efficiency of unprocessed Salvadora persica (miswak) chewing stick practice as an alternative to a standard toothbrush. Recently, a local Malaysian company has invented and successfully mass manufactured a world-first Salvadora persica toothbrush where its nylon bristles are primarily mixed with miswak powder and natural silica. With the benefits of Salvadora persica properties intact, it is also claimed to be effective without the application of toothpaste. However, the claim remains to be fully elucidated. There is also no randomized controlled trial available evaluating the efficacy of Salvadora persica toothbrush to date. Therefore, the aim of this study is to evaluate the effectiveness of the newly invented Salvadora persica toothbrush on oral health, particularly on anti-plaque and anti-gingivitis effects. The patient related-outcomes of Salvadora persica on a short-term use will also be assessed. The hypotheses of this study are that Salvadora persica toothbrush does not contribute to the significant effects on oral health and there is no difference in the use of Salvadora persica chewing stick, Salvadora persica toothbrush as well as the standard toothbrush on anti-plaque and anti-gingivitis in a standardized manner. Additionally, a hypothesis that there is no patient-related outcome of Salvadora persica on a short-term use has also been devised. A randomized, single blind, and parallel clinical study will be conducted over a five-week period involving the healthy non-dental students of the National University of Malaysia. This study consists of three groups of different oral hygiene tools: (i) Salvadora persica toothbrush; (ii) Salvadora persica chewing stick; and (iii) Standard toothbrush and toothpaste as control. The primary outcomes of this study are the clinical parameters that will be recorded at four different appointments. Salvadora persica toothbrush is expected to show positive effects to that of standard toothbrush with respect to plaque and gingivitis control. This study is thus designed to provide an insight on Salvadora persica toothbrush as a good preventive home care therapy.

Start: December 2020

Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment

Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. However, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. Moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus. Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. However, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment. Therefore, the aim of the study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation and prevent a dysbiosis of the oral microbiome.

Start: November 2020

A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health in Partial Denture Wearers

The purpose of this study is to investigate the effectiveness of usage of a range of oral products (toothpaste, mouth rinse, denture cleanser) on the oral health of partial denture wearers compared to existing oral hygiene habits.The hypothesis is that there is no treatment difference in the oral health when using the range of products for 12 weeks compared to no intervention.

Start: October 2020

Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment in Adult Patients

Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. However, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. Moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus. Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. However, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment. Therefore, the aim of our study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation, systemic inflammation and prevent a dysbiosis of the oral microbiome.

Start: October 2020

Evaluation of Matrix Metalloproteinase 8 Salivary Test for Diagnosis of Periodontitis

Despite the great progress in understanding the causes of infertility, the reason for the failure of pregnancy has not been discovered among 25% of infertile couples. Some studies have shown the negative impact of periodontal disease on the reproductive potential of women. It is known that there is an elevated level of matrix metalloproteinase 8 (MMP8) in the gingival fluid of patients with periodontitis. It is possible to establish a fast diagnosis of periodontitis by using a non-invasive assay based on monoclonal antibodies to two epitopes of MMP-8. The goal of the research is to use the above described assay in order to compare the level of MMP8 in the gingival fluid of infertile patients with the control group of fertile women, depending on the existence of periodontal disease. It is expected to find significantly higher values of MMP8 in infertile patients in relation to the fertile patient with/without periodontitis. The prompt treatment of periodontitis in preconception care of this group of women could have a significant impact on the improvement of fertility and ability to achieve pregnancy.

Start: January 2018

Oral Hygiene and Systemic Inflammation (Perio-Hygiene 1.0)

The purpose of the study is to evaluate the impact of oral hygiene changes (drastic plaque and gingival inflammation reduction) on markers of systemic inflammation and indicators of oral health related quality of life and other aspects related to overall well-being. The primary objective is to assess a possible reduction of systemic inflammation as measured through blood bio-markers one month after drastic changes of plaque accumulation. As primary outcome measure, the level of high-sensitive C-reactive protein (hs-CRP) will be assessed.

Start: April 2019

A Clinical and Imaging Study to Evaluate a Novel Dentifrice

There is a need for toothpastes that more effectively remove oral biofilm, inhibit biofilm re-formation and support periodontal health. This is particularly important for patients with long-term orthodontic fixtures or prosthodontic appliances, and also for debilitated, diabetic and immunocompromised patients. The objective of this study is to evaluate the effects of toothpastes on plaque presence and removal, gingival and periodontal health, dental hard tissue mineralization, erosion, abrasion, and microstructure as well as dry/sore mouth. In addition to clinical scoring and photographs, tooth and gum sensitivity, saliva volume, pH and buffering and enamel health may be evaluated using tooth samples worn on removable dental retainers. These samples will be examined outside of the mouth using advanced optical techniques such as Optical Coherence Tomography (OCT), Fluorescence, various forms of microscopy and spectroscopy.

Start: October 2014

Immunological and Regenerative Implications of Corrosion of Dental Materials

During orthodontic treatment intraoral corrosion results with release of nickel and titanium ions from orthodontic appliances in surrounding tissues. Those transported in the saliva and blood may cause a series of side effects from hypersensitivity reactions and soft tissue proliferation to cyto and genotoxicity. Nickel is one of the strongest contact allergens, present in numerous dental alloys. The aim of this project is to investigate the immune potential of nickel and titan ions (development of allergies, changes in cariogenic potential of dental plaque, resistance of gingivitis to therapy, and bacterial resistance to antibiotics) and changes in performance of orthodontic appliances with repercussion on regeneration of bone and periodontal tissues.

Start: December 2015

Efficacy of Hyaluronic-acid and Hydrogen-Peroxide Mouthwash in Gingivitis Treatment

A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the prevention and management of complications associated gingivitis by film forming action.

Start: June 2020

To Evaluate the Efficacy of Probiotics Toothpastes in Improvement of Gingivitis and Prevention of Periodontal Diseases Via Modulating the Oral Microbiota

Gingivalis is the one of the most common diseases of oral cavity, and affects more than 75% of adult populations worldwide. The present studies demonstrated that the addition of probiotics in toothpastes or mouthwashes could reduce dental plaques and gum inflammation, and improve oral health. This study was designed to assess the effectiveness of probiotic toothpastes during the supportive therapy of moderate to sever gingivalis patients.

Start: February 2020