Influence of Individual Phenotypical Dimension (IPD) on Hard Tissue Stability Following Lateral Bone Augmentation: a Two-centre Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Linear dimensional (LD) changes of the buccal aspect of the augmented alveolar ridge
研究概览
简要总结
Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. This study investigates whether the amount of bone that regrows depends on a person's original bone shape, known as the Individual Phenotypical Dimension (IPD). The aim is to compare the bone stability and overall results between two approaches: adding bone only up to the original bone line (IPD) or adding bone beyond it (over-contour augmentation). Over the course of a year, the study will assess not only bone and soft tissue healing, but also gum blood flow, implant success, and patient satisfaction.
There will be two treatment groups in this study - one group will receive bone grafting just up to their natural bone shape, while the other group will receive a slightly larger graft that extends about 3 mm beyond it. Throughout the study CBCT scans will be taken to assess bone changes around the implant area in order to measure how the bone shape and thickness change over time after surgery.
详细描述
This is a two-centre, prospective, non-inferiority clinical trial with two parallel study groups aimed at radiographically comparing the differences in hard tissue (lateral augmentation) stability following different GBR treatment protocols (contour augmentation or over-contour augmentation). The study consists of 12 visits over a period of approximately 16 to 18 months.
The study will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust, United Kingdom (leading centre) and at Implant Research Centre & Department of Periodontology, School of Dental Medicine, University of Belgrade, Serbia, according to local guidelines and procedures/interventions detailed below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, clinicians performing the surgical intervention and primary outcome examiner will be unblinded. Conversely, participants and researchers analyzing secondary outcomes (e.g., intra-oral & extra-oral scans, aesthetic scores) will be blinded to treatment allocation throughout the whole study duration.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>18 years old) patients
- •Good medical and psychological health
- •Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment
- •Need of a tooth/teeth replacement in the incisor, canine or premolar maxillary region that could be provided with an implant-supported fixed prosthesis
- •A relatively symmetrical maxillary arch
- •A nearly intact contra-lateral alveolar ridge
- •At least one neighbouring natural tooth present with healthy periodontal conditions
- •After implant placement, presence of a buccal bone dehiscence/ fenestration or buccal bone plate thickness of ≤ 1.5 mm requiring GBR (Monje et al., 2022; Jensen et al.,2023, Group 1 ITI Consensus Report).
- •At least 4 weeks of post-extraction socket healing and no ridge preservation prior to implant placement.
- •No acute infection at the site; adequate availability of bone apical and palatal to obtain implant primary stability
- •A functional occlusion with a minimum of 4 occlusal units (i.e., pairs of occluding posterior teeth)
- •Willingness to read and sign a copy of the Informed Consent Form (ICF) after reading the Patient Information Sheet (PIS), and after the nature of the study has been fully explained and potential questions fully answered.
排除标准
- •Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II).
- •Self-reported HIV or other severe immunosuppression.
- •Self-reported alcoholism or chronic drug abuse.
- •Heavy smokers ( > 10 cigarettes/day)
- •Patients reporting use of vape/e-cigarettes
- •Self-reported pregnancy or lactation
- •Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status or bone metabolism (e.g., bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
- •Chronic treatment with anticoagulants (including Aspirin), corticosteroids, immunosuppressants or other medications that may influence blood coagulation/count.
- •Untreated caries lesions in neighbouring teeth and untreated/uncontrolled periodontal disease; If patients require periodontal treatment (non-surgical and/or surgical), this will be arranged outside the study protocol and completed prior to enrolment;
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene in the area of implant placement.
- •Patients requiring maxillary sinus lift surgery before implant placement or presenting bone dimensions (at any time point of the study) that do not allow implant placement or there is no clinical indication to perform study procedures (i.e. bone augmentation, implant placement).
- •Patients not willing to receive animal-derived biomaterials for GBR.
- •Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
研究组 & 干预措施
Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD
Implant placement and simultaneous guided bone regeneration (GBR) beyond Individual Phenotypical Dimension (IPD). In this group, lateral bone augmentation will be performed as an over-contour augmentation of 3 mm beyond IPD.
干预措施: Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD (Procedure)
Group 2 (Control Group): IP and GBR as a contour augmentation up to IPD
Implant placement and simultaneous guided bone regeneration (GBR) up to IPD. In this group, lateral bone augmentation will be performed up to IPD
干预措施: Group 2 (Control Group): IP and GBR as a contour augmentation up to IPD (Procedure)
结局指标
主要结局
Linear dimensional (LD) changes of the buccal aspect of the augmented alveolar ridge
时间窗: baseline, immediately after implant placement (IP) and 12 months after implant loading (IL)
The primary objective is to compare radiographically the differences in the hard tissue stability (linear dimensional changes of the augmented ridge) following guided bone regeneration (GBR) simultaneous to implant placement (IP), when lateral bone augmentation is performed up to Individual Phenotypical Dimension (IPD) (control group) or as an over-contour augmentation beyond IPD (test group).
次要结局
- Cross-sectional area changes of the buccal aspect of the augmented ridge(baseline, immediately after IP and 12 months after IL)
- Blood flow changes(baseline, immediately after, and at 1, 3, 7, 15, 30 days after IP)
- Soft tissue volume changes(baseline, immediately after, and at 1, 3, 7, 15, 30 days after IP, immediately after IL, 6 and 12 months after IL)
- Extra-oral 3D geometric changes(baseline, immediately after, 1, 3, 7, 15 and 30 days after IP)
- Full mouth plaque score (FMPS)(baseline, 6 and 12 months after IL)
- Full mouth bleeding score (FMBS)(baseline, 6 and 12 months after IL)
- Probing pocket depth (PPD)(baseline, 6 and 12 months after IL)
- Gingival recession (REC)(baseline, 6 and 12 months after IL)
- Clinical attachment level (CAL)(baseline, 6 and 12 months after IL)
- Suppuration(baseline, 6 and 12 months after IL)
- Implant success/survival(6 and 12 months after IL)
- Changes in the pink esthetic score (PES)(immediately after IL, 6 and 12 months after IL)
- Changes in the white esthetic score (WES)(immediately after IL, 6 and 12 months after IL)
- Early healing index(1, 3, 7, 15 days after IP)
- Patient satisfaction(immediately after IL, 6 and 12 after IL)
- Life impact questionnaire(1, 3, 7 and 15 days after IP)
- Patients' aesthetic satisfaction(immediately after IL, 6 and 12 months after IL)