Alveolar Ridge Preservation (ARP) Versus Spontaneous Healing in Large Buccal Bone Defects After Tooth Extraction in the Posterior Mandible
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The frequency of additional bone augmentation at implant placement.
研究概览
简要总结
Rationale: To determine the effect of alveolar ridge preservation (ARP) versus spontaneous healing (SH) in large buccal bone defects in the posterior mandible.
Objective: To evaluate whether ARP using a xenograft (XG) (Cerabone plus) or an allograft (AG) (Maxgraft granules) covered by a membrane (Jason membrane) reduces the need for additional bone augmentation either prior to or during implant placement in the posterior mandible compared to spontaneous healing Study design: Prospective randomized clinical study with 10-year follow-up.
Study population:
Inclusion criteria: patients are 18 years or older and in need for extraction of a (pre)molar in the posterior mandible with at least one adjacent tooth and a buccal bone defect of >50%.
Exclusion criteria: the presence of active periodontal disease, uncontrolled diabetes mellitus, a history of or current use of chemotherapy or radiation in the head and neck area, history of or current use of medication related to osteonecrosis of the jaw, smoking (> 5 cigarettes a day, disability (physical and/or mental), making the patient unable to maintain basic oral health or follow the study protocol, pregnancy (in case of pregnancy, the treatment is postponed until after the delivery).
Intervention (if applicable): Atraumatic extraction of a (pre)molar in the posterior mandible will be performed. Patients will then be included based on the dimensions of the buccal bone defect (buccal bone defect of >50%). 66 patients will be randomly divided in either the XG group, the AG group or the SH group (control). In the ARP groups (XG and AG), following tooth extraction, ARP will be performed using either a XG (Cerabone plus) or an AG (Maxgraft granules), both covered by a membrane (Jason membrane). In the control group, the alveolus will be left for spontaneous healing, following tooth extraction. After 4-6 months, a cone bean computed tomography (CBCT) scan will be performed to determine the possibility of implant placement with or without additional augmentation. Implant placement will be performed in all groups with or without guided bone regeneration (GBR).
Main study parameters/endpoints: Frequency of additional augmentation at implant placement.
详细描述
Extraction of the teeth in the posterior region of the mandible may be an indication for the placement of dental implants. However, after extraction of the teeth, the alveolar ridge undergoes changes due to resorption. Resorption is most pronounced on the buccal side and might complicate implant placement as is could lead to proximity issues with the inferior alveolaris nerve of the mandible.
Alveolar ridge preservation (ARP) is commonly performed technique aimed at preserving available bone after tooth extraction. It facilitates delayed implant placement, reducing morbidity and providing optimal esthetic outcomes for implant placement. This procedure is performed using autogenous bone grafts, bone substitutes such as xenografts or allografts or a mixture of both. Also, membranes can be used to direct the growth of new bone.
A thin buccal bone wall is an indicator for bone loss that may compromise the integrity of the buccal bone and lead to biologic and esthetic complications. When the buccal bone wall has a width of < 1.5mm, it is considered an indication for ARP.
ARP is found to be effective in reducing bone loss and facilitating implant placement after extraction in the anterior region and for multi-rooted sides. However, most available evidence including RCTs, involves patients with at least 50% of buccal bone intact. Consequently, it is uncertain whether the efficacy ARP is also applicable in situations involving damaged sockets (buccal bone loss >50%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A minimum age of 18 years old
- •In need for extraction of a single (pre)molar in the mandible that needs to be replaced by an implant
- •At least one adjacent tooth
- •A buccal bone defect after extraction of 50% or more
排除标准
- •Active periodontal disease
- •Uncontrolled diabetes mellitus
- •History of or current chemotherapy or radiation in the head and neck area
- •History of or current use of medication related to osteonecrosis of the jaw
- •Heavy and moderate smokers (>5 cigarettes a day)
- •Unable to maintain basic oral health (physical and/or mental)
- •Pregnancy (in case of pregnancy, the treatment is postponed until after the delivery)
研究组 & 干预措施
ARP with xenograft
ARP with xenograft (Cerabone ® plus, Botiss Biomaterials GmbH, Zossen, Germany) covered by a native collagen membrane (Jason ® membrane, Botiss Biomaterials GmbH, Zossen, Germany) and delayed implant placement (4-6 months after extraction).
干预措施: Alveolar Ridge Reconstruction (Procedure)
ARP with allograft
ARP with a freeze dried bone allograft (Maxgraft®, Botiss Biomaterials GmbH, Zossen, Germany) covered by a native collagen membrane (Jason ® membrane, Botiss Biomaterials GmbH, Zossen, Germany) and delayed implant placement (4-6 months after extraction).
干预措施: Alveolar Ridge Reconstruction (Procedure)
Spontaneous healing
spontaneous healing and delayed implant placement (4-6 months after tooth extraction).
结局指标
主要结局
The frequency of additional bone augmentation at implant placement.
时间窗: During implant placement
The frequency of additional bone augmentation at implant placement will be assessed during implant placement.
次要结局
- Implant survival(From the moment of implant placement until 10 years of loading)
- Profilometric outcome measure(after intake, extraction, implant placement, placement of the final crown (after 2 weeks, 1 year, 3 years, 5 years and 10 years))
- Prosthetic success(from placement of the final crown until 10 years of loading)
- Histological outcome measures(After implant placement)
- Subjective Clinician-reported outcome measures related to the clinician's perception(After the surgical procedures (extraction and implant placement))
- PROMS(at intake, after extraction, after implant placement, and 2 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown)
- Chair Time(At all surgical procedures (extraction, ARP, implant placement))
- Costs(After 10 years of loading)
- Implant success(From one year after implant placement until 10 years of loading)
- Keratinized mucosal width (KMW)(1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown.)
- Pocket probing depth (PPD)(1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown)
- Bleeding on probing (BOP)(1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown)
- Surgical complications (swelling, dehiscence, haemorrhage, infection)(2 weeks post extraction and implant placement)
- Marginal bone levels (MBL)(Post implant placement and 1, 3, 5 and 10 years after placement of the final crown.)
- Volumetric changes of the bone(after extraction, before implant placement, 1 year, 3 years, 5 years and 10 years after placement of the final crown)
- Orofacial Esthetic Scale (OES-NL)(2-4 weeks after placement, and 1, 3, 5 and 10 years after loading of the final crown)
研究者
Dr. Justin Pijpe
Principal Investigator
Erasmus Medical Center