Bone Loss Clinical Trial
Official title:
Reinforced PTFE Meshes Versus Customized Titanium Meshes: Randomized Clinical Trial
Verified date | March 2024 |
Source | GBR Academy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to compare two surgical techniques for the treatment of the maxillary and mandibular bone atrophies.. Therefore, the main purpose is to compare the (i) the percentage of post-operative complications (ii) the three-dimensional bone gain with customized titanium meshes (test group - the medical device is digitally designed and made with customized laser sintering modality, customized to the defect of each patient) and with titanium-reinforced PTFE mesh (control group - the medical device is cut, shaped, and manually modelled to the patient's defect by the operator himself.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | November 1, 2024 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Adult patients, over the age of 18, in good general health. - Patients with partial edentulism of the maxilla or mandible, with a 2mm minimum to a 12mm maximum vertical bone defect, which requires a three-dimensional bone regeneration intervention in order to have a fixed implant supported rehabilitation. - Obtaining informed consent for experimental treatment and processing the personal data. Exclusion Criteria: - Poor oral hygiene, - Untreated periodontal disease - Smoking habit> 10 cigarettes / day; - Abuse of alcohol or drugs - Pregnancy - Patients with odontostomatological infections and / or systemic infections in progress; - Patient with uncontrolled diabetes mellitus or other metabolic diseases; - Patients with severe changes in liver and kidney function. - Patients with confirmed uncontrolled autoimmune disorders. - Patients subjected radiation therapy in the head or neck region in the last 5 years. - Patients undergoing immunosuppressive and / or immunocompromised therapy. |
Country | Name | City | State |
---|---|---|---|
Italy | School of Dentistry - University of Bologna | Bologna |
Lead Sponsor | Collaborator |
---|---|
GBR Academy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of healing complications after reconstructive surgery | Healing complications are evaluated based on the chronological order in which they occur:
immediate exposure occurs within the 1st month early exposure occurs between the 1st and the 3rd month late exposure occurs between after the 3rd month Evaluation of low-grade and high-grade infection of medical devices used for bone regeneration. The former complications are classified as: Class A, including flap damage (soft tissue perforation or laceration) Class B, including neurological damage (paresthesia or disesthesia) Class C,including vascular damage (hemorrhage). The latter complications are divided into four classes, according to the presence and extent of exposure, as well as the presence of a purulent exudate: Class I, membrane exposure <3 mm, no purulent exudate Class II membrane exposure >=3mm, no purulent exudate Class III: membrane exposure, with purulent exudate |
6 months | |
Secondary | Level of anxiety of the patient measured with a Visual Analogue Scale (VAS) | Level of anxiety measured with a Visual Analogue Scale (VAS), where 0 represents the absence of anxiety and 10 represents the maximum level of anxiety. | Immediately before/after the surgery | |
Secondary | Pain level of the patient measured on a Visual Analogue Scale (VAS) | Pain level measured on a Visual Analogue Scale (VAS), where 0 represents the absence of pain and 10 represents the maximum level of pain. | Post operative from immediately after surgery to the 14th day after the surgery. | |
Secondary | Total Number of painkillers taken post-operative | Total amount of pain killers taken from post operative to the 14th day (a two week period) which will be recorded in the patient's diary. | Post operative from immediately after surgery to the 14th day after the surgery. | |
Secondary | Dosage of painkillers | Dosage of painkillers measured as the number of painkillers per day, which will be reported in a diary by the patients. | Post operative from immediately after surgery to the 14th day after the surgery. | |
Secondary | Limitation in daily functions measured on a Visual Analogue Scale (VAS) | Limitation in daily functions measured on a Visual Analogue Scale (VAS), where 0 represents the absence of limitations and 10 represents the total limitation | Post operative from immediately after surgery to the 14th day after the surgery. | |
Secondary | Number of patients' post-operative signs and symptoms | Self-assessment of patient's post-operative signs and symptoms (absence or presence swelling, nausea, hematoma, bruising, bleeding), which will be reported | Post operative from immediately after surgery to the 14th day after the surgery. | |
Secondary | Discomfort level of the patient using a Post-operative Symptom Severity (PoSSe) | Discomfort level measured using a Post-operative Symptom Severity (PoSSe) questionnaire.
Questions are a forced choice, requiring the respondent to tick one box. The questions evaluate the discomfort level in different areas: eating: ability to eat, ability to swallow, enjoyment of food, altered taste sensation speech: voice affected, inability to open mouth, speech affected sensation: tingling of lips or tongue, numbness of lips or tongue appearance: bruising of face and/or neck, swelling of face and/or neck, life affected by appearance pain: days of pain, pain controlled by painkillers, life affected by pain sickness: days of nausea and vomiting, number of attacks of nausea and vomiting on worst day interference with daily activities: interference with work/housework/daily activities, interference with leisure activities |
Post operative, measured on 14th day after the surgery | |
Secondary | Level of satisfaction of the patient using a Health-Related Quality of Life (HrQoL) | Level of satisfaction measured using a Health-Related Quality of Life (HrQoL) questionnaire. Each of the questions are answered with the options of "I am quite satisfied, I'm satisfied, I have no idea, I am dissatisfied, and I am quite dissatisfied".
The questions evaluate: satisfaction with the overall treatment chewing ability cleaning of the prothesis esthetics of the prothesis speaking ability |
Post operative, 6 months and 12 months after the dental prosthesis dental prosthesis has been placed. | |
Secondary | Willingness of the patient to undergo the intervention recorded on a Visual Analogue Scale (VAS) | Willingness to undergo the intervention recorded on a Visual Analogue Scale (VAS), where 0 corresponds to "I will never undergo this type of surgery again" and 10 corresponds to "no problem repeating surgery if necessary". | Post operative measured on the 7th day and on the 14th day. | |
Secondary | Time required for the CBCT analysis and design of the medical device | Time required for the CBCT analysis and design of the medical device measured in a total number of minutes. | Pre-operative, 2 weeks before the day of the surgery | |
Secondary | Total operative time required for the surgery measured from immediately before to immediately after the surgery. | Total operative time measured from the time of incision to the end of the suture. | During procedure | |
Secondary | Total chair time measured from immediately before the surgery to immediately after the surgery. | Total chair time measured from the time the patient enters the surgery to the time the patient leaves the room | During procedure | |
Secondary | Level of operator satisfaction Measured on a 5 point scale | Level of operator satisfaction rated on a 5-point scale, ranging from ''0=absolutely not satisfied'' to ''5 = absolutely satisfied'' | Immediately after the surgery | |
Secondary | Level of operator confidence with the technique | Confidence level with the technique used on a 5-point rating scale, ranging from "0=absolutely not confident" to " 5 = absolutely confident" | During procedure | |
Secondary | Costs related to the technique | Costs related to the GBR technique measured as the total costs of the materials used: number of pins, number of screws, number of membranes, number of biomaterials, number of sutures | Immediately after surgery | |
Secondary | Operator anxiety level recorded on a Visual Analogue Scale (VAS) | Operator anxiety level recorded on a Visual Analogue Scale (VAS), where 0 represents the absence of anxiety and 10 represents the maximum level of anxiety | From 3 days before the surgery to immediately before the surgery, during the intervention and at the 14th day after the surgery |
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