Factors and Consequences Associated With Diabetic Foot Problems Among Diabetic Patients in Jordan
Background: Diabetes mellitus (DM) is a common chronic metabolic condition with numerous consequences, including diabetic foot ulcers. diabetic foot ulcer (DFU) is the major cause of non-traumatic lower extremity amputations. DFU is linked to several risk factors, including a lack of information and inadequate foot care practices. In Jordan, statistics on diabetic foot are few, with no evidence of the impact of patient education on disease outcomes. Aims: To assess DFU-related risk factors and complications among DM patients in Northern Jordan. Also, analyze the impact of educational intervention on their behavior. Methods: A prospective cross-sectional sample of 200 DM patients, including 94 with a history of DFU was initially selected. Subsequently, a smaller cohort of 105 patients was randomized into either a control group or an intervention group after providing written informed consent. The control group received standard care, while the intervention group received standard care supplemented with formal educational session followed by ongoing education on foot care using mobile health by a clinical pharmacist. Diabetic foot-associated risk factors and complications were assessed. Foot care practices and medication adherence were evaluated for both the control and intervention groups at baseline and again after 8 weeks of follow-up. Binary logistic regression was employed to assess factors associated with DFU. The Chi-square test and independent sample t-test were used to compare the behavior between the two groups before and after the intervention.
Phase
N/ASpan
105 weeksSponsor
King Abdullah University HospitalIrbid
Recruiting
The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems.
The adhesive cementation of ceramic partial coverage restorations is a technique-sensitive process essential for achieving optimal retention and marginal integrity. While dental resin cements are commonly used for adhesive luting of indirect ceramic restorations, concerns exist regarding their long-term reliability due to susceptibility to degradation over time and polymerization shrinkage-related issues. This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth, aiming to address these drawbacks. It will follow a split-mouth design with 60 participants selected based on strict criteria. The preparation and delivery appointments follow specific guidelines, incorporating the Morphology Driven Preparation Technique (MDPT). Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness. The objectives of this clinical trial are to evaluate the clinical performance of posterior partial coverage coronal restorations utilizing two different luting systems (preheated resin-based composite versus conventional dual-cure resin cement) in a split-mouth study design.
Phase
N/ASpan
96 weeksSponsor
King Abdullah University HospitalIrbid
Recruiting
Healthy Volunteers
Color Stability and Wear Resistance of Direct Flowable and Preheated Composite Using the Injectable Technique
The design of study will be a modified split-mouth randomized clinical trial with two study groups. 20 patients will be recruited with the need of at least 6 anterior aesthetic restorations. A total of 142 restorations will be assigned into two groups. In the first group, 71 anterior teeth will be restored with flowable composite veneer restorations, and the second group 71 anterior teeth will be restored with heated composite veneer restorations. Both treatment groups will be done using the injectable resin technique. The following parameters will be evaluated at baseline, 6 months and 12 months of clinical service. Color stability will be evaluated using the Vita classical shade guide and a spectrophotometer. Wear resistance will be evaluated by measuring the volumetric material loss through superimposition of images taken at each follow up on baseline images taken by scanning of gypsum replicas using a 3D laser scanner. Clinical performance will be evaluated using the USPHS criteria. It is expected that the color stability, wear resistance and clinical performance of the heated composite restorations will be superior to the flowable restorations.
Phase
N/ASpan
627 weeksSponsor
King Abdullah University HospitalIrbid
Recruiting
Healthy Volunteers
The Effect of Therapeutic Exercise on Cartilage Morphology and Physical Function for Individuals at High Risk of Knee Osteoarthritis
Background: Degenerative meniscus tears are common in individuals over 35 and are associated with early stages of knee osteoarthritis (OA) (1,2). Metabolic and microstructural changes within the cartilage occur before surface breakdown, which can now be detected using advanced MRI techniques such as T2 mapping. Exercise therapy, specifically progressive resistance and aerobic exercises, has shown benefits for knee OA patients, but its effects on early cartilage degeneration are poorly understood. Objective: The primary objective of this study is to determine the efficacy of PRE and aerobic exercises on the metabolic function and microstructure of cartilage in individuals with degenerative meniscus tears but without radiographic evidence of knee OA. Secondary objectives include evaluating the impact of these exercises on clinical outcomes, such as pain, disability, and physical function, and assessing the feasibility of recruitment and retention for a larger trial. Methods: The study will enroll 54 participants, who will be randomized into three groups: PRE, aerobic exercise, and control. Each group will undergo a 3-month supervised exercise program. MRI scans will be used to measure changes in cartilage composition, while clinical outcomes will be assessed using patient-reported and performance-based measures. Intervention Groups: Group 1 (PRE): Participants will perform progressive resistance exercises focusing on strengthening the quadriceps. The exercises will be adjusted based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique. Group 2 (Aerobic Exercise): Participants will engage in aerobic exercise sessions using a stationary bike, aimed at improving cardiovascular fitness and knee joint mobility. Group 3 (Control): Participants will receive standard of care, including general strength and balance exercises as per current clinical guidelines. Assessments: MRI Imaging: Advanced MRI techniques (T2 mapping) will be used at baseline and after 3 months to assess changes in cartilage composition. Clinical Outcomes: Patient-reported outcomes will include the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee (IKDC) score. Performance-based outcomes will include the single-leg squat, single-leg hop test, sit-to-stand on a one-foot test, step-up test, and Bruce treadmill test. Inclusion Criteria: Adults aged 35-55 years Symptomatic degenerative medial meniscus tears. No radiographic evidence of knee OA (Kellgren-Lawrence grade 0-1). Ability to provide informed consent. Willingness to participate in the exercise intervention. Exclusion Criteria: Existing diagnosis of knee OA (Kellgren-Lawrence grade 2 or higher). Repairable meniscus injuries or prior meniscus repair. Previous knee surgery or significant knee injury within the past 6 months. Presence of inflammatory arthritis or other significant comorbidities. Contraindications to MRI or inability to participate in exercise programs. Study Outcomes: Primary Outcomes: Changes in T2 relaxation times in the cartilage, indicating alterations in cartilage composition and health. Secondary Outcomes: Improvements in clinical outcomes, including pain, disability, and physical function as measured by KOOS, IKDC, and performance-based tests. Feasibility Metrics: Recruitment rates, adherence to the exercise program, and retention rates over the study period. Analysis: A mixed ANOVA will be used to compare changes in outcomes between groups, with adjustments for multiple comparisons. Baseline characteristics will be compared using t-tests and chi-square tests.
Phase
N/ASpan
300 weeksSponsor
Jordan University of Science and TechnologyIrbid
Recruiting
Healthy Volunteers
Effects of Bio-active Desensitizer on Reduction of Tooth Sensitivity Caused by In-office Bleaching.
The participants will be informed about the nature and objectives of the study; however, they will not be informed what desensitizing material they would receive. The study will be a double blinded (Patient and evaluator) randomized clinical trial with a sample size of 51, 17 participants for each group (n=17). Bleaching process: A lip and cheek retractor will be placed. The gingival tissues from the right first molar to the left first molar will be isolated using a light-cured resin dam to prevent the whitening gel from coming into contact with the gingival tissue. Participants' lips will be painted with Vaseline, and protective eyewear will be used. To aid in the isolation process, a plastic suction tip with high suction power will be used. Opalescence Boost in Office Whitening Gel, 40% Hydrogen Peroxide bleaching material (Ultradent Products, South Jordan, UT, USA) will be applied directly on the labial tooth surface from the right first premolar to the left first premolar. A total of three (20-minute) applications will be completed in each bleaching session. Participants will undergo 2 bleaching sessions with one-week interval. Participants will be scheduled for lower arch whitening after 14 days. Application of the desensitizer: The participants will be assigned randomly to three study groups. The first group will receive a bio active desensitizer, the second group will receive a fluoride gel and the third group will receive a placebo gel without a desensitizer (Table 2). A small amount of the gel assigned for each participant will be applied directly on the labial surface of each tooth and left undisturbed for three minutes; care will be taken to cover the entire labial surface, and the gel will be carried interproximally as much as possible. Shade evaluation: Teeth shade will be evaluated subjectively and objectively. Subjectively it will be evaluated using VITA classical shade guide which has 16 tabs ranging from B1 (lightest value) to C4 (darkest value) by matching the color with the middle third of the maxillary anterior teeth. One evaluator will record the shade of the participants' teeth at baseline (before whitening), directly after bleaching, and at days 3, 7, and 14 days follow up periods. Photographs will be taken using a digital camera immediately after the whitening and at each shade evaluation to document results. Also teeth shade will be evaluated objectively using VITA easy shade spectrophotometer (VITA Easyshade V; VITA Zahnfabrik, Bad Säckingen, Germany). The tooth must be well hydrated before analyzing the tooth color. The shade of the teeth in VITA classical A1-D4 and VITA 3D-MASTER shades will be instantly measured and displayed on the screen. One evaluator will record the shade of the teeth and the shade will be recorded at baseline, immediately after bleaching and at 3, 7 and 14 days follow up periods. Sensitivity Evaluation: Post-bleaching sensitivity will be evaluated by relying on patient's feeling of pain. Sensitivity evaluation: All participants will be given a sensitivity sheet to record the post-whitening sensitivity of the whitened teeth on daily basis up to 14 days according to the visual analog scale of pain (VAS). The participants will be asked to record the stimulus that caused sensitivity, including hot, cold, or other. The duration of pain, whether seconds, minutes, or hours, will be recorded for the 14-day follow-up period.
Phase
N/ASpan
40 weeksSponsor
King Abdullah University HospitalIrbid
Recruiting
Healthy Volunteers
Posterior Implant-Supported Modified Monolithic Zirconia and Metal-Ceramic Single Crowns: 5 Years Study
Background: Dental implants restored with single crowns (SCs) have been reported to have a comparable survival rate and fewer technical complications compared to multiple-unit implant-supported FDPs. Porcelain-fused to metal restorations were the golden standard option for implant supported reconstructions in the past, but nowadays, the application of all-ceramic restorations in general and specifically zirconia as a restorative material for implant-supported single crowns has increased utilizing the CAD/CAM technology. The continuous technological progress in both the computer-based development and the dental manufacturing process ensures new opportunities in the clinical workflow. A fully digital pathway in a model-free approach or a combination of these workflows is now possible. Purpose: The purpose of this randomized controlled clinical trial is to investigate the prosthetic outcomes of posterior implant-supported single crowns (SCs) with a modified monolithic zirconia or metal-ceramic design utilizing the digital workflow at 1, 3 and 5 years of loading. Materials and methods: This single-blind split mouth study will enroll 60 participants, having to receive 120 dental Implants. They will be scheduled for a bilateral posterior single-unit prosthetic rehabilitation supported by one implant in the posterior region of the maxilla or the mandible (premolars, molars). A fully digital pathway will be followed. A CT scan will be performed without any template. An intraoral optical impression using CEREC Omnicam scanner will be made. A virtual set-up of the prosthetic reconstruction, as well as a surgical template with optimal 3-D implant positioning will be designed then printed using a 3-D printer without the need of any physical model. Straumann bone level implants with either a wide diameter (Ø4.8 mm) or regular diameter (Ø4.1 mm) with a minimum length of 8 mm will be inserted. Implants will be loaded after 3 months of submerged healing. A second intraoral optical impression will be made using CEREC Omnicam scanner and Straumann scanbody. The implant-supported prosthetic suprastructure will be designed. Implants will be randomly allocated to either the test group modified monolithic zirconia crowns (MMZ) or the control group metal ceramic crowns (MC), using a computer-generated randomization list. A digital model with movable dies will be 3-D printed, then used to adjust restoration in terms of occlusal and proximal contacts. Prefabricated screw-retained Titanium abutments (Variobase Abutment; Straumann) will be used as the metal substructures of the crowns and will be secured to lab analogues on the digitally printed casts. Metal/ zirconia substructures with a hole for the screw retention will be designed using the CAD software and will be anatomically reduced by 1 mm to allow for porcelain veneering then will be laser-printed/ dry milled. Hand layering of glass ceramic will be made on the surface. Crowns will be cemented extraorally to titanium abutments using dual cure resin cement to make one-piece screw-retained single crown. The screw-retained single crowns and titanium abutments will be inserted intraorally with 35 Ncm torque and screw-access holes will be restored with Teflon and light-polymerized composite resin. The implant-supported SCs will be examined after 1, 3 and 5 years for survival and technical complications. Clinical significance: to evaluate the survival and prosthetic complication rates of zirconia-ceramic and metal-ceramic implant-supported single crowns at 1, 3 and 5 years of service. In addition to that, the digital workflow for implant supported single crowns will be evaluated for efficiency, accuracy, time and cost compared to conventional workflow.
Phase
N/ASpan
244 weeksSponsor
Jordan University of Science and TechnologyIrbid
Recruiting
Healthy Volunteers
Color Masking Potential of Bioactive and ICON Materials
After sample size calculations were carried out a total sample size of 150 teeth will be included (75 teeth will be treated with ICON; and 75 other teeth will be treated with HI-Bond universal]. Split mouth study design involves treating WSLs in two different quadrants in each participant. Treatments will be done according to manufacturer's instruction. The WSLs in the teeth of one quadrant will receive treatments with the ICON (DMG, America) , and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal (MEDICLUS, south Korea). Before receiving the treatment, the WSLs will be tested at baseline by Quantitative light-induced fluorescence (QLF) device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive.
Phase
N/ASpan
57 weeksSponsor
King Abdullah University HospitalIrbid
Recruiting
Healthy Volunteers
Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin
The regeneration procedures have been focused on immature teeth since there is a need for a treatment modality to give a chance for root maturation, apical closure, and root canal walls thickening which cannot be achieved by other procedures like apexification. Immature teeth have a greater chance of pulp tissue regeneration. The presence of an open apex will allow the stem cells from the apical papilla to migrate into root canals. In the case of mature teeth, the presence of complex anatomy causes difficulties in disinfection. In addition, the presence of narrow apical pathway for stem cells migration makes them weak candidates for regeneration. However, the use of conventional root canal therapy has many drawbacks. A retrospective study reported that even though conventional root canal therapy had prolonged tooth survival, pulp removal still led to tooth loss in comparison with teeth with normal pulp. Losing the pulp means reduced levels of proprioception in addition to the innate immunity that is disallowed after root canal therapy leaving remaining bacterial colonies in the root canal system. By applying regeneration techniques in mature teeth, we have the chance to avoid the previously mentioned drawbacks of root canal therapy and restore the neurovascular system with immune cells that will act as a line of defense mechanism against microbial attacks. A few studies and case reports have investigated the effectiveness of regeneration procedures using blood clot as a scaffold in treating mature necrotic teeth. The idea that led toward the use of platelet concentrates as a scaffold was that concentrated platelets and growth factors collected in plasma solutions could promote local healing. Comparing it to blood clot, it increased cell proliferation over time due to its increased concentration of growth factors. Given the drawbacks of conventional root canal treatment and limited studies in the literature on using other treatment modalities in treating mature necrotic teeth, hence the need for a randomized clinical trial with large sample size and long follow-ups emerge. This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth.
Phase
N/ASpan
244 weeksSponsor
King Abdullah University HospitalIrbid
Recruiting
Healthy Volunteers
Radiographic Assessment of the Healing Pattern Associated With Periradicular Endodontic Microsurgery
After meeting the inclusion criteria, a total of 44 Patients in need of endodontic microsurgery with persistent symptoms after acceptable primary root canal treatment or failed retreatment with persistent symptoms/periapical lesions will be included in this study. Participants will be randomly allocated to group one; conventional periradicular surgery or group two; piezoelectric periradicular microsurgery. A preoperative digital periapical and limited view cone beam computed tomography (CBCT) radiographs will be taken for each patient. At 12-18 months recall visit a second digital periapical radiograph and limited view CBCT will be taken. All images will be evaluated on high-definition LCD display with installed ImageJ software and CBCT software, and window settings will be fixed for all cases. Radiographs will be evaluated by two calibrated dentists. The excised root tip with their surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °C by immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic laboratory. Fixed specimens will be demineralized in 10% formic acid and processed. Serial sectioning with hematoxylin and eosin staining will be done to locate the areas with the most severe reactions. In addition, the Taylor modification of the Brown-Brenn staining will be used to detect the presence of bacteria.
Phase
N/ASpan
261 weeksSponsor
King Abdullah University HospitalIrbid
Recruiting
Healthy Volunteers
Postoperative Symptoms Following Endodontic Microsurgery
This randomized prospective clinical study will be conducted at the postgraduate clinics, Department of Conservative Dentistry, at Jordan University of Science and Technology. Ethical approval will be sought from the JUST Institutional ethics and human Research Board (IRB) committee. Sample size and randomization A total of 44 adult patients will be recruited for this clinical trial. Participants will be randomly allocated to one of the two treatment modalities. Randomization will be carried out by sealed envelope online software. For the observational part of the study, no randomization or blinding will be applied. Patients will be treated free of charge and their travel expenses will be compensated for all follow up visits. Preoperative management : Clinical and radiographic assessment : - The patient demographic information, chief complaint and history of the chief complaint, medical and dental history will be registered. A thorough extra-oral and intra-oral examination will be undertaken (an existing swelling , sinus tracts, quality of coronal restoration margins and its history, occlusal relations, gingival biotype , any gingival recession and periodontal assessment ) will be registered . Percussion and palpating tests will be applied. Pre-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it. Limited view cone beam computed tomography scan of the diseased tooth will be obtained for each patient preoperatively (SFV). Root length and axis, Lesion size and features, bone crest level and any radiographic abnormality will be interpreted and registered. All patients will receive periodontal scaling a week or two before the surgery. Surgical procedure Prior to surgery , patients will be asked to rinse their mouth with chlorhexidine 0.12% . After which, local anesthesia containing epinephrine will be given. The surgical flap design and procedure will be selected as per case deem , and the flap will be elevated gently and retracted. The Root apex will be located and osteotomy will be applied. The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets (Gingi-Pak , California state , USA),Biodentine retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it. Post-operative management : Immediately after the microsurgery the patients will be asked to apply cold ice packs on the surgical site for 20 mins at the clinic, during this time the post-operative instructions will be given .
Phase
N/ASpan
174 weeksSponsor
King Abdullah University HospitalIrbid
Recruiting
Healthy Volunteers