Comparative Study Between Demineralized and Mineralized Allogeneic Dentin Grafts for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Alveolar Ridge Width (Buccolingual Dimension)
研究概览
简要总结
This clinical investigation aims to assess how two different allogeneic dentin graft materials - one de-mineralized and the other mineralized - influence bone preservation following extraction of a single upper posterior tooth. A total of 45 patients will be randomly allocated into three equal groups: a socket-only spontaneous healing group (control), a de-mineralized dentin graft group, and a mineralized dentin graft group. Over a six-month period after extraction, measurements will be taken using CBCT to monitor changes in ridge width, height, and bone density. Secondary outcomes include patient-reported pain, postoperative swelling, satisfaction levels, width of keratinized tissue, and histomorphometric data from biopsy samples at implant placement. Findings from this trial may support evidence-based decisions in alveolar ridge preservation and help clinicians choose the most predictable grafting strategy before implant placement.
详细描述
The alveolar ridge experiences rapid remodeling after tooth extraction, often resulting in significant bone loss if no graft is placed. Clinical observations indicate that an extraction site may lose roughly half of its original width within six to twelve months, severely reducing the bone available for future implants or prosthetic support. This resorption occurs because removal of the tooth and its periodontal ligament eliminates the normal mechanical stimulation that maintains the surrounding bone. Alveolar ridge preservation techniques aim to counteract this remodeling by placing a graft in the extraction socket to maintain bone dimensions and support healing. Preserving the ridge anatomy in this way is critical for subsequent restorative procedures such as dental implant placement or denture support.
In practice, a variety of graft materials have been used to support alveolar ridge preservation. Autogenous bone grafts (harvested from the patient's own body, for example from the iliac crest or intraoral sites) have osteogenic and osteoinductive properties, but require a second surgical site and provide limited graft volume. Alternative materials include allogeneic bone (processed human bone from donors) and xenogeneic bone (such as bovine-derived hydroxyapatite), which are readily available but may integrate more slowly and raise concerns about immune reaction or disease transmission. Synthetic or alloplastic graft materials (calcium phosphates, bioactive glasses, polymers, etc.) are also used, although they typically act only as osteoconductive scaffolds and may not match the biologic activity of natural tissues. Given these limitations, there is ongoing interest in novel graft sources that can offer both safety and biological efficacy.
One promising graft material is dentin, the calcified tissue comprising the bulk of a tooth beneath the enamel. Chemically, dentin closely resembles bone: it is roughly 70% mineral (hydroxyapatite) and 20% organic matrix (predominantly type I collagen) by weight, along with non-collagenous proteins and embedded growth factors. Because dentin is acellular and avascular, it is inherently well-tolerated when used as a graft. Importantly, its organic matrix contains signaling molecules such as bone morphogenetic proteins (BMPs) and other growth factors that are naturally osteoinductive. In clinical practice, an extracted tooth can be cleaned and converted into graft material by grinding it into particulate form or shaping it into a block. Clinical studies have shown that autogenous tooth-derived grafts (using a patient's own extracted tooth) can effectively support socket preservation and guided bone regeneration. However, this approach is limited by the availability of teeth in each patient and by variability in processing methods, which can affect the consistency of the graft material.
Dentin grafts can be prepared in different forms. Demineralized dentin matrix (DDM) is produced by treating the dentin with acid to remove most of the mineral phase, leaving a collagen-rich matrix that retains the dentin's organic proteins and growth factors. DDM is highly osteoinductive: by removing the crystalline mineral, the embedded signaling molecules (such as BMPs and transforming growth factors) are exposed, creating a bioactive scaffold that strongly stimulates new bone formation. In contrast, a fully mineralized dentin graft (for example, ground whole tooth particles that are not demineralized) retains the hydroxyapatite content, which contributes rigidity and initial volume stability. These mineralized grafts act primarily as an osteoconductive scaffold and release bioactive molecules more slowly as they resorb. In practical terms, demineralized dentin grafts are believed to accelerate early bone ingrowth, whereas mineralized dentin grafts may better preserve the initial socket architecture and support gradual long-term remodeling.
Allogeneic dentin grafts are obtained from healthy human donor teeth that have been processed and sterilized under controlled conditions. The use of donated extracted teeth provides a scalable graft source and repurposes material that would otherwise be discarded. Processing typically involves cleaning away any attached soft tissues, removing enamel and cementum, and grinding the remaining tooth structure into particles. Sterilization (for example by freeze-drying, gamma irradiation, or other validated methods) ensures the graft is safe for implantation. For demineralized allografts, an additional acid step is applied to decalcify the particles. These preparation steps remove or inactivate cells and pathogens, minimizing immunogenic components. Preclinical studies suggest that properly processed allogeneic dentin matrix can induce bone formation with minimal immune reaction or rejection. However, standardized clinical evidence on allogeneic dentin grafts remains limited.
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)
盲法说明
Participants, outcome assessors, and the statistician are blinded to group allocation. Care providers are blinded to graft type in the demineralized and mineralized groups but not in the control group.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 60 years.
- •Medically healthy patients classified as ASA I.
- •Presence of a single non-restorable tooth indicated for extraction in the posterior maxilla.
- •Adequate oral hygiene, with plaque and bleeding indices both below 20%.
- •Sufficient bone volume to allow socket preservation without requiring simultaneous augmentation.
- •Patients willing to participate in the study and able to provide written informed consent.
- •Ability to commit to follow-up visits for up to 6 months.
排除标准
- •Smokers or tobacco users of any form.
- •Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes).
- •Conditions affecting bone metabolism (e.g., osteoporosis, long-term corticosteroid therapy).
- •Pregnant or lactating women.
- •History of radiotherapy in the head and neck region.
- •Active infection or suppuration at the extraction site.
- •Immunocompromised patients or those on immunosuppressive therapy.
- •Patients taking medications known to impair healing (e.g., bisphosphonates).
- •Allergy or hypersensitivity to any study-related materials.
研究组 & 干预措施
Demineralized Allogeneic Dentin Graft
After atraumatic tooth extraction, the socket is filled with demineralized allogeneic dentin particulate graft. The material is processed and sterilized according to standardized laboratory protocols. A resorbable collagen dressing is placed over the graft, followed by site closure. This arm evaluates the regenerative effectiveness of demineralized dentin on ridge preservation.
干预措施: Demineralized Allogeneic Dentin Graft (Biological)
Mineralized Allogeneic Dentin Graft
Following atraumatic extraction, the socket is grafted with mineralized allogeneic dentin particulate material processed and sterilized under controlled conditions. A resorbable collagen dressing is applied prior to closure. This arm assesses the ridge preservation outcomes produced by the mineralized form of dentin graft.
干预措施: Mineralized Allogeneic Dentin Graft (Biological)
结局指标
主要结局
Change in Alveolar Ridge Width (Buccolingual Dimension)
时间窗: Baseline (immediately after extraction) and 6 months post-operative
Measurement of the buccolingual width of the alveolar ridge using standardized Cone-Beam Computed Tomography (CBCT). Width is measured at predetermined reference points to assess dimensional bone changes following grafting.
Change in Alveolar Ridge Height (Vertical Dimension)
时间窗: Baseline and 6 months post-operative
Vertical height of the alveolar ridge measured radiographically on CBCT at standardized anatomical landmarks to quantify bone height changes over the healing period.
Bone Density at the Grafted Site
时间窗: 6 months post-operative
Bone density at the extraction site measured using CBCT expressed in Hounsfield Units (HU) to evaluate bone quality gained after grafting
次要结局
- Postoperative Pain Levels (VAS Score)(24, 48, and 72 hours post-operative)
- Postoperative swelling(Baseline (preoperative), 24, 48, and 72 hours post-operative)
- Patient Satisfaction Score(6 months post-operative)
- Width of Keratinized Tissue(Baseline and 6 months post-operative)
- Histomorphometric Analysis of Bone Core Biopsies(6 months post-operative (at implant placement))
研究者
Ahmed Abdelhamid Musa Abdelaziz
Master's Student, Department of Periodontology, Faculty of Dentistry, Kafrelsheikh University
Kafrelsheikh University
