2024-517976-39-00
尚未招募
2/3 期
A multicentre clinical trial: Alveolar bone augmentation using MSCs and biphasic calcium phosphate granules prior to dental implants (Behandling Maxillofacial)
概览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 6 months after the regenerative surgery, immediately prior to implant placement.
概览
简要总结
To assess the safety and efficacy of using autologous mesenchymal stem cells and biomaterials to regenerate bone in order to enable adequate implant placement.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Patient should be able to understand and complete the informed consent.
- •Age 18 years or older.
- •Insufficient bone ridge width (≤ than 4 mm) and or height at the recipient site for implant placement.
- •Healthy oral mucosa, at least 2 mm keratinized mucosa.
- •Female candidates of child bearing potential (WOCBP) -as defined by CTFG 2 (a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile due surgery)- must be referred to their physician for a pregnancy test 1,2 before inclusion in the study. (See the study protocol for full list of acceptable contraceptives and requirements for pregnancy testing during the study)
- •The WOCBP candidates will only be included in the study if the pregnency tests are negative. These patients must continue using the contraceptives until the placement of dental implants (6 months after bone augmentation procedure considering that pregnancy is not considered as a contraindication for normal dental implant).
- •Female candidates that have entered menopause for less than 12 months must also be referred to confirm post-menopausal state by testing the level of follicle stimulating hormone (FSH).
排除标准
- •General contraindications for dental and/or surgical treatments
- •Concurrent or previous radiotherapy of head and neck region
- •History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
- •Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient`s history and concurrent HbA1c levels (HbA1c > 53 mmol/mol).
- •Inflammatory and autoimmune disease of the oral cavity.
- •Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.
- •Patients with a history of drug addiction.
- •Patients with known hypersensitivity against antibiotics (both Amoxicillin and Clindamycin), all painkillers (paracetamol, ibuprofen and level II painkillers) or xylocaine. Mouthwashes as chlorhexidine and anti-inflamatory agents will be used carefully considering possible allergies and contraindications for using these products.
- •Thin keratinized mucosa (< 1mm)
- •Current smokers and those who have quitted smoking in the last 4 weeks (there is evidence that nicotine and cotinine levels disappear after 4 weeks of non-smoking).
结局指标
主要结局
Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 6 months after the regenerative surgery, immediately prior to implant placement.
Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 6 months after the regenerative surgery, immediately prior to implant placement.
次要结局
- Ability to place implants in the reconstructed area 6 months after the grafting procedure
- Linear changes in mm measured with a gauge 2 mm below the alveolar crest, between the first surgery before applying the regenerative intervention and 6 months later at the second surgery, immediately before placing the implants
- Adverse effects (AEs) and soft tissue healing (uneventful healing, wound dehiscence, membrane, exposure, redness, signs of infection, swelling) at 2 and 4 weeks and 6 months.
- Morbidity associated with procedures: o Number and type of postoperative anti-inflammatory medication o The degree of reported pain using a VAS scale.
- Patient’s satisfaction: - Patient reported outcomes (PROMs) using a structured questionnaire with Likert scales. - Patient’s overall quality of life (QoL) will be assessed with the use of validated tools: Health-related Quality of Life (HRQoL) and Oral Health-Related Quality of Life (OHRQoL).
- Fate of the transplanted MSCs by liquid biopsy technology (screening, and 2 weeks after the bone augmentation) surgery by collecting peripheral blood samples and plasma/sera)
- Bone promoting activity of the intervention by evaluating the core biopsies harvested during re-entry procedure at the sites receiving dental implant by micro-computed tomography (μCT) and histology
- The need of secondary bone augmentation around the dental implants placed in correct prosthetic driven position
- Implant stability at time of implant installation, at abutment surgery, at loading, and 12 months after loading (using Osstell® radiofrequency implant stability quotients).
- Evaluate local conditions, hygiene and absence of inflammation
研究者
Kamal Mustafa
Scientific
University of Bergen
研究点 (3)
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