Dimensional Soft Tissue Changes Around Dental Implants Following the Use of a Collagen Matrix or a Connective Tissue Graft. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- 3D intra-oral volume changes in mucosal soft tissue following augmentation
研究概览
简要总结
This study aims to characterize the healing pattern following soft tissue augmentation procedure concomitant to implant placement.
详细描述
This study will characterize, for the first time, the healing pattern of soft tissues around dental implants in case of soft tissue augmentation and in comparison, to normal healing.
An innovative and comprehensive geometric/thermal imaging analysis will be employed that is non-contact and non-invasive to patients and will allow to characterize the healing process in a 2D-3D dimensional and volumetric way.
This approach, combined with LSCI and clinical and radiographic outcomes, will provide new data on the biology and critical phases of soft tissue healing around implants, as well as on the stability and aesthetics of the peri-implant tissues with different grafts.
Patient-reported outcome measurements (PROMs) will also be used to assess the level of pain and discomfort associated with soft tissue augmentation procedures.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, both participants and clinicians performing the surgical intervention will be un-blinded.
Conversely, outcome examiners will be blinded to treatment allocation throughout the whole study duration.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years.
- •Good medical and psychological health.
- •Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients require periodontal treatment (non-surgical and/or surgical), this has to be arranged outside the study protocol and completed at least 30 days prior to the enrolment.
- •Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region.
- •Presence of adequate bone for implant placement without need for significant bone regeneration. In particular, the patients should have a bucco-palatal residual alveolar width of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone (De Bruyckere et al., 2018).
- •A residual alveolar height >8 mm, enough inter-arch space for a crown and a minimum distance of 6 mm from the adjacent teeth.
- •The width and height will be confirmed after x-ray examination in Visit 1 (or extra visit). Cases of small apical fenestration (≤ 25% of implant length) after implant placement will not be excluded, but will be treated according to the GBR principle (collagen membrane associated with a deproteinized bovine bone graft) to re-establish the bone contour and without over contouring.
- •At least 8 weeks of post-extraction socket healing had occurred in the edentulous site.
- •Willingness to sign the informed consent form.
排除标准
- •Self-reported pregnancy and lactation.
- •Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation.
- •Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
- •HIV or viral hepatitis.
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
- •Self-reported alcoholism or chronic drug abuse.
- •Heavy smokers (>10/cigarettes per day).
- •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 be obtained or simple instructions could be followed.
- •Full-mouth bleeding (BOP) and plaque (PI) scores >30% or sites with periodontal pocket depth >5 mm at the completion of the pre-treatment phase.
- •Very thin or very thick biotypes that according to the clinician's judgement would either risk to have complications or would not benefit from receiving a graft.
- •<2 mm KT buccally (from the mucogingival junction to the coronal aspect of the crestal soft tissue).
研究组 & 干预措施
No Soft tissue augmentation surgery
No soft tissue augmentation concomitant to implant placement. Negative control group.
干预措施: No soft tissue augmentation (Procedure)
Soft tissue augmentation surgery with Fibro-Gide
Soft tissue augmentation concomitant to implant placement with a porcine, volume-stable cross-linked collagen matrix (Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland).
Test group.
干预措施: Soft tissue augmentation surgery with Fibro-Gide (Procedure)
Soft tissue augmentation surgery with patient's CTG
Soft tissue augmentation concomitant to implant placement with a connective tissue graft (CTG) taken from the patient's palate or retromolar area.
Positive control group.
干预措施: Soft tissue augmentation surgery with CTG (Procedure)
结局指标
主要结局
3D intra-oral volume changes in mucosal soft tissue following augmentation
时间窗: 12 month post- implant loading.
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
3D intra-oral volume changes in mucosal soft tissue following augmentation
时间窗: Immediately after implant placement.
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
3D intra-oral volume changes in mucosal soft tissue following augmentation
时间窗: 7, 14 and 30 Days post implant placement
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
3D intra-oral volume changes in mucosal soft tissue following augmentation
时间窗: 12 weeks and 16 weeks post- implant loading.
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
次要结局
- 2D-3D intra-oral thermal changes(baseline to 1, 3, 7, 14 and 30 days after implant placement)
- Changes in gingival thickness(implant placement to 12 weeks after implant placement)
- 3D extra-oral volumetric changes(baseline, immediately after implant placement, 7, 14 and 30 days after implant placement)
- changes in height of keratinised tissue(baseline to 30 days, 12 weeks and 16 weeks after implant placement and 12 months post loading)
- Patients' reported outcomes (PROMS) in oral impact on Daily Performances (OIDP) questionnaire (OIDP)(At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.)
- PROMs based on the evaluation of patient's perception about therapy(At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.)
- changes in vascularisation(before and immediately after implant placement, and at post-operative days 1, 3, 7, 14, and 30)
- soft tissue aesthetics(At implant loading and at 12 months after loading.)
- PROMs based on the evaluation of global changes in quality of life(At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.)
- Post-operative swelling and oedema(At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.)