Lattakia, Syrian Arab Republic
Re-infusion of Unwashed Shed Blood During Off-pump Surgery
Introduction Blood transfusion is often required during cardiac surgical operations, and may be associated with known risks and complications. Off-pump coronary artery surgery has been shown to be associated with reduced need for blood transfusion, and cell-savers are widely used as an additional method for reducing blood transfusion demands. Auto-transfusion of unwashed suctioned blood intra-operatively is thought to increase the inflammatory response and infective complications, but data related to this approach are scares. Aims To assess the effects and benefits of using an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump surgery and compare it to the conventional no re-infusion technique. Assessments will focus on: - clinical outcome - transfusion requirements - inflammatory response - alveolar/arterial oxygen pressure gradients - cognitive status - cost-benefit Study design A prospective study involving patients undergoing off-pump coronary artery bypass surgery. Patients will be randomized to two groups; an isolated cardiotomy circuit for re-infusion of unwashed shed blood will be used in group (a) and the conventional no re-infusion technique will be used in group (b). Participants Patients undergoing off-pump coronary artery bypass surgery. Setting Damascus University Cardiac Surgery Hospital
Phase
N/ASpan
105 weeksSponsor
Damascus UniversityDamascus
Recruiting
The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA
The best pain control regime following TKA is controversial. While opioids have an excellent analgesic effect, they also have many side effects. The investigators are conducting a randomized controlled trial to compare the severity of pain following primary unilateral TKA when multimodal drug periarticular injunction is used with the standard pain control regime. The investigators will enroll patients undergoing primary unilateral TKA and randomly allocate them into one treatment group. The first will undergo the procedure with periarticular injection before the closure is composed of a mixture of 20ml of low body weight bupivacaine 5mg/ml plus 1ml of ketorolac 30mg/ml plus 0.5ml adrenaline 1mg/ml injected in medial and lateral retinaculum, medial and lateral collateral ligaments, quadriceps and patellar tendon, joint capsule, subcutaneous fat, and the second will go standard TKA with pain control using opioids, NSAIDS, and paracetamol. The severity of postoperative pain is the primary outcome studied, as well as preoperative complications and any drug side effects, the data will be collected by a fellow researcher who is blinded to the interventions, and the patients will be blinded too. Randomization will be done by a research fellow who is not involved in patient treatment or care.
Phase
N/ASpan
92 weeksSponsor
Damascus UniversityDamascus
Recruiting
Healthy Volunteers
Three Techniques in Bioceramic Apexification for Necrotic Immature Incisors
Phase
N/ASpan
109 weeksSponsor
Damascus UniversityDamascus
Recruiting
Evaluation of Dental Implants After Using Several Bone Splitting Techniques
The study's objective is to compare ridge width gain after osseodensification, piezosurgery, or magnetic mallet after ridge splitting with simultaneous implant implantation in individuals with narrow alveolar ridges. 36 patients will be randomly allocated into three groups. Ridge splitting followed by piezo and bone expander will be performed with simultaneous implant placement in group 1. osseodensification bure will be performed after ridge splitting with simultaneous implant placement in group 2. magnetic mallet will be performed after ridge splitting with simultaneous implant placement in group 3.
Phase
N/ASpan
103 weeksSponsor
Damascus UniversityDamascus
Recruiting
Healthy Volunteers
Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures
Complex regional pain syndrome is the most challenging complication to overcome following distal radius fractures. The precise etiology still needs to be fully understood. It is thought that ways of prevention could be the most effective way of managing this dilemma, as no effective treatment is yet to be found. One of the ways of prevention is vitamin C supplementation, as it is thought that the toxic oxygen radicals play a significant role in the inflammatory process that ultimately manifests as CRPS. Vitamin C, as an antioxidant, could play a role in stopping this process. The theoretical background of this research is that CRPS commonly occurs following distal radius fractures, and vitamin C supplementation could play a role in prophylaxis. To assess that, the investigator is conducting a randomized controlled trial. The trial is designed as a multicenter, randomized, controlled study. Two hospitals in Syria, Damascus, participated in this study using the same experimental design. Adults (18 years or above) with distal radius fractures who will be seen in the emergency department of each hospital will be asked to participate in this study. Patients will be asked to start the trial medication on the day of the fracture following the suitable treatment method chosen by the orthopedics consultant in each hospital. Capsules had to be taken once daily for 90 days. Patients will be allocated randomly to receive either a placebo or 1g of vitamin C daily. The study's endpoint will be defined as the presence of CRPS at any moment up to one year after the fracture. All participants and physicians will be unaware of the treatment allocation. The diagnosis will be built upon the Budapest criteria, which will be checked in every follow-up for one year. Patients will be seen after two weeks, four weeks (or when the cast was removed), six weeks, 12 weeks, six months, and 12 months. The protocol will not compromise the adequate fracture treatment, either conservative or operative, by closed reduction and percutaneous pinning. If necessary, patients will be seen more often and at other times than planned.
Phase
4Span
94 weeksSponsor
Damascus UniversityDamascus
Recruiting
Healthy Volunteers
The Effect of a Removable Complete Denture Over One Implant in the Lower Jaw on Hearing Ability
Tanaka et al mentioned in their study that in accordance to the WHO, about one third of the people older than 65 years old is somehow affected by hearing loss. Although hearing loss is not a life-threatening condition but it is related to medical and psychological problems such as depression and social isolation. Reduction in the occlusal vertical dimension is considered one of the factors that cause a decline in hearing ability. A study of Shreedhar et al found that there is improvement in hearing ability between loading two implants in the canine regions in the mandible with a removable complete overdenture and after one month of the loading. In their study, the hearing threshold improved from 40 to 25 decibel and the improvement is associated with transmission of vibrations from the oral cavity through the bone. Implants in the mandible has been associated with improvement in hearing although the mandible is not in direct contact with the skull, and Ozer et al study found that the hearing acuity through the bone was not different between the upper and lower jaw. In Tanaka et al study teeth loss was associated with the increased prevalence of hearing loss. King et al found important improvement in previously existed hearing loss after the replacement of missing teeth with a removable complete overdenture. Furthermore, Schell et al study found that hearing acuity was worse in the edentulous patients group than the other groups, which suggests a relation between hearing loss and the dentate status. A similar study of Peeters et al mentioned that the discrepancy between patients who had complete dentures and patients who had loss in the occlusal vertical dimension strengthen the hypothesis that there is an association between hearing loss and the occlusal vertical dimension. As for the single implant retained complete overdenture, there has been several studies, which are mentioned in carl's Misch book that found this treatment to be valid, especially for patients who suffer from removable dentures and have problems in mastication. The available evidence on the relationship between dentate status and hearing loss is limited, so understanding this relationship could help prevent or delay the occurrence of hearing loss. The possibility of suggesting implant placement and loading the implant with a removable complete overdenture as a way to improve bone-conducted hearing in edentulous patients will be studied. In this study, we are going to measure the hearing ability of edentulous patients 4 times: First, before using the complete denture. Second, after using it for one month and before placing the implant. Third, 10 days after placing the implant in the midline of the mandibular jaw. Fourth, after 1 month of loading the implant with the removable complete overdenture. The null hypothesis is that there is no statistically important difference in hearing thresholds by bone conduction between the studied periods of time. This study will be done on 30 patients and a written consent will be taken. The hearing ability test will be done in Al-Mowasat hospital after the examination of the patient by an otolaryngologist before the first hearing test. The hearing ability test is called Pure Tone Audiometry or PTA.
Phase
N/ASpan
151 weeksSponsor
Damascus UniversityDamascus, Dimashq
Recruiting
Healthy Volunteers
Enhancing Soft Tissues Around Inserted Implants by Two Different Methods
This clinical trial is designed to evaluate and compare the performance of two soft tissue augmentation techniques-autogenous subepithelial connective tissue graft (CTG) and xenogeneic collagen matrix (XCM, Mucoderm®)-when used concurrently with dental implant placement in the aesthetic zone of the anterior maxilla. The rationale for this study stems from the clinical challenge of achieving optimal soft tissue esthetics and function following tooth loss. While CTG has long been considered the gold standard for increasing peri-implant soft tissue thickness, it requires a secondary surgical site, which may lead to donor site morbidity, limited tissue availability, and increased surgical time. In contrast, XCM offers a promising alternative that is biocompatible, readily available, and less invasive. Patients aged 18 years or older with a single missing tooth in the aesthetic zone, adequate bucco-palatal bone (≥6 mm), and at least 5 mm of keratinized tissue width will be considered eligible for the study. The enrollment process begins with a thorough screening process involving clinical and radiographic examinations, including a low-dose, small-field CBCT scan and an intraoral scan. These imaging modalities allow for accurate digital implant planning using specialized software, ensuring optimal implant positioning. The digital data will be used to fabricate a stereolithographic surgical guide and design a custom CAD/CAM screw-retained provisional restoration. Following successful screening and informed consent, the surgical phase commences. Under local anesthesia, a full-thickness flap is elevated at the implant site. Guided by the digital plan, a dental implant is precisely positioned using the surgical guide. At this point, participants are allocated to one of two intervention groups based on a strict randomization protocol. In the CTG group, a connective tissue graft is harvested from the palatal mucosa using the de- epithelialized free gingival graft technique. The harvested graft is then trimmed to match the dimensions of the recipient site and carefully positioned under the elevated flap to augment the soft tissue. The donor site is sutured using gelatin matrix to ensure proper healing. This technique, while effective, is associated with postoperative discomfort and additional surgical time due to the need for a second operative site. Conversely, in the XCM group, soft tissue augmentation is achieved using a xenogeneic collagen matrix (Mucoderm®). The graft, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures. Following soft tissue augmentation, a screw-retained provisional restoration is attached immediately, contributing to both function and esthetics during the healing phase. The primary outcome of the study is the increase in the buccal soft tissue profile, quantitatively assessed using intraoral scans to generate digital surface models at three critical time points: preoperatively (T0), immediately after surgery (T1), and 3 months postoperatively (T2). Secondary outcomes include clinical assessments-such as probing depth, plaque index, bleeding on probing, keratinized tissue width, graft dimensions, wound closure, surgery time, and complications-as well as radiographic evaluation of marginal bone loss. In addition, patient-reported outcome measures (PROMs), including postoperative pain, swelling, aesthetic satisfaction, and willingness to undergo the same treatment again, will be recorded using validated visual analogue and Likert scales. Aesthetic outcomes, including mid-facial recession, Pink aesthetic score, and mucosal scarring index, will also be documented. The data will be analyzed on an intention-to-treat basis by an independent statistician. Statistical comparisons between the two groups will help determine whether the xenogeneic collagen matrix offers comparable or superior results to the autogenous connective tissue graft regarding soft tissue volume augmentation, esthetic outcomes, and patient satisfaction. Ethical approval has been obtained from the University of Damascus, and the trial follows the CONSORT guidelines. The results will be disseminated through peer-reviewed publications and presentations at professional conferences, contributing valuable evidence to the field of implant dentistry. Overall, this study is expected to provide insight into whether XCM can serve as a reliable, less invasive alternative to CTG, thereby potentially enhancing patient outcomes and reducing the complications associated with donor site morbidity.
Phase
N/ASpan
96 weeksSponsor
Damascus UniversityDamascus
Recruiting
Healthy Volunteers
Clinical Outcomes of Biologically Oriented Preparation Technique
The study aims to evaluate the clinical performance of all-ceramic crowns on teeth prepared with two different types of preparations. This randomized controlled trial will include 60 teeth divided into two groups: 30 teeth will be prepared with BOPT, and 30 teeth will be prepared with shoulder margins. All teeth will receive monolithic or bi-layered ceramic crowns. Patients are planned to attend follow-up visits after 3, 6, 12, and 18 months, respectively, after cementation. Probing depth, gingival recession, bleeding on probing, gingival index, gingival thickness, patient opinion, and mechanical and biological complications are all recorded at check-up appointments.
Phase
N/ASpan
192 weeksSponsor
Damascus UniversityDamascus
Recruiting
Impact of AR Glasses on Children's Behavior During Dental Nerve Blocks
This study will evaluate the effectiveness of an augmented reality glasses. Pain, anxiety and general behavior will be evaluated during inferior alveolar nerve block using these behavioral scales, Venham's picture test (VPT), Pulse Oximeter, Wong-Baker face, observational behavioral scale (using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") and general behavior scale (Houpt) VPT scale consists of 8 associated drawings of a child, with each drawing showing a pair of children in two positions: non-anxious (value 0) and anxious (value 1). The child is asked to point to the child that expresses their feelings. The scale ranges from 0 to 8. If a child scores 6 or higher, they will be excluded from the research sample due to negative behavior. Anxiety is measured by monitoring pulse and oxygenation at five different times: before starting, 10 minutes later, when applying topical anesthetic, during the administration of the anesthetic injection, and immediately upon completion of the anesthetic injection. Using the Wong-Baker Faces scale to assess the level of pain after the anesthesia injection by asking the child to indicate the face that best represents their condition. The FLACC scale is a behavioral tool used to assess pain during the administration of an anesthesia injection. The child is recorded on video from before the injection starts until it is finished. The mobile phone is set up to film the child during the injection, and an external observer evaluates the child's behavior. The observer monitors five variables: (Face), (Legs), (Activity), (Cry), and (Consolability). Each variable is scored from 0 to 2, resulting in a total score ranging from 0 to 10. The Houpt scale was used to measure general behavior in children, as it consists of 6 points, starting from grade 1, which is the most violent behavior shown by the child during treatment, to grade 6, which is complete satisfaction with treatment.
Phase
N/ASpan
18 weeksSponsor
Damascus UniversityDamascus
Recruiting
LOAD VS Levofloxacine Concomitant
Phase
4Span
187 weeksSponsor
Damascus HospitalDamascus
Recruiting