Effect on the Periodontal Phenotype of Flapless Alveolar Decortication and Augmentation During Orthodontic Treatment: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Soft tissue contour changes pre- and post- orthodontic therapy
研究概览
简要总结
Research Question
While the reduction in treatment times and the patient satisfaction after periodontally accelerated osteogenic orthodontics (PAOO) are well sustained in the scientific literature, there is still controversy regarding if grafting leads to i) change of the periodontal phenotype and ii) greater stability of post-orthodontic treatment outcomes, highlighting the need of controlled clinical trials.
Aims of the Project
The aim of this randomized clinical trial (RCT) is to compare piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane, in orthodontic non-growing patients. The primary aim will be to determine the impact of this surgical protocol on the hard and soft tissue changes occurring on the buccal aspect of the dentition. Secondary objectives will include the assessment of the comparative impact on treatment duration, rate of tooth movements, presence of root resorption, periodontal parameters, bone level changes and patient-reported outcome measures (PROMs) between the two groups.
详细描述
Methodology
Study Design and Population Sample The study is designed as a single-blind (examiner), parallel groups, RCT to compare piezocision-assisted orthodontics concomitant to soft tissue grafting (soft tissue thickening group) or to bone grafting (bone augmentation group).
Patient Inclusion: Informed Consent, Patient Registration and Randomization If a patient fulfills the described inclusion/exclusion criteria, he/she will be invited to join the study. After informing the patient about the objectives, interventions, risks, benefits, and monitoring of the study, they will be asked to sign an informed consent form. Both the protocol of the study and consent forms have been approved by the local ethics committee at Hospital Clínico San Carlos (internal code 23/463-E, August 29, 2023).
Study Visits - Baseline Pretreatment orthodontic analysis will consist on intraoral scanner, panoramic x-rays, lateral cephalograms, CBCT scan and extra- and intra-oral photographs. Full-mouth periodontal examinations, including measurements of probing depth (PD) and gingival recession/overgrowth, will be taken at six sites per tooth, in all teeth excluding third molars, and will be rounded to the nearest millimetre using a UNC-15 probe. Plaque index (PlI) and bleeding on probing (BoP) will be also registered. The thickness of the soft tissue will be measured by an ultrasound scanner (PIROP Biometric G-Scan, Echoson Company, Poland), while the microvascularization will be measured by Laser Speckle Contrast Imaging (LSCI, PeriCam PSI System; Perimed AB, Sweden).
Study Visits - Orthodontic Treatment Orthodontic treatment will be carried out with clear or metal brackets (patients will be allowed to choose). The bonding method will be standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.012-in. nickel-titanium arches forms will be placed. Subjects will return every other week and the archwires will be changed only when full bracket engagement will be achieved. The sequence of archwires will be as follows: 0.018-in., 0.014 × 0.025-in., and 0.018 × 0.025-in. copper nickel-titanium archwires were used for alignment, while 0.019 × 0.025-in. stainless-steel archwires were used for fine-tuning. Following the alignment steps, impressions will be taken, and a blinded senior orthodontist will validate appliance removal or provided advice regarding further adjustments. The study will end six months after the piezoincisions, when it is expected that a square or rectangular stainless-steel arch will be placed.
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
Blinded parties will not be aware of the type augmentation used during the intervention.
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain) looking for orthodontic therapy.
- •The inclusion criteria will be as follows:
- •patients requiring maxillary and/or mandible orthodontic treatment;
- •patients with permanent dentition in stage 5 or 6 of the cervical vertebral maturation method as described by Baccetti et al. (2002);
- •minimal to moderate maxillary and/or mandibular anterior crowding at baseline (arch length discrepancy from 3-8 mm); and
- •adequate oral health (i.e. periodontal health, absence of periapical infections and untreated caries).
排除标准
- •subjects with periodontitis stage III or IV (Papapanou et al., 2018);
- •subjects with poor oral hygiene (represented as full-mouth plaque scores (FMPS) >25%);
- •ongoing chronic drug therapy influencing bone metabolism (e.g. steroids, immunosuppressors or antiresorptive drugs);
- •subjects with uncontrolled systemic diseases (e.g. diabetes);
- •pregnancy and
- •subjects not willing to comply with the study visits
研究组 & 干预措施
Collagen matrix
a cross-linked volume stable collagen matrix (VCMX; Geistlich Fibro-Gide, Geistlich Pharma AG)
干预措施: flapless alveolar decortication with augmentation (Procedure)
Xenograft
a graft consisting of bovine hydroxyapatite xenograft (Geistlich Bio-Oss; Geistlich Pharma AG), covered by a native collagen membrane (Geistlich Bio-Gide; Geistlich Pharma AG), tagged with pins at the ends.
干预措施: flapless alveolar decortication with augmentation (Procedure)
结局指标
主要结局
Soft tissue contour changes pre- and post- orthodontic therapy
时间窗: 6 months
Linear and volumetric changes of soft tissue (gingiva) using superimposition of STL files of dental casts at baseline and post-ortho
Bleeding on probbing (BoP)
时间窗: 6 months
Changes in BoP dichotomously assessed and expressed as the percentage of positive sites out of the total sites assessed
Plaque index (PlI)
时间窗: 6 months
Changes in PlI dichotomously assessed and expressed as the percentage of positive sites out of the total sites assessed.
Probing depth (PD)
时间窗: 6 months
Changes in PD and gingival recession/overgrowth, allowing for the calculation of clinical attachment level (CAL)
Orthodontic tooth movement
时间窗: 6 months
Space analyses will be performed on study models with digital calipers. Similarly, the intercanine and intermolar distances will be measured at baseline and after the treatment to determine the level of expansion
External apical root resorption (EARR)
时间窗: 6 months
Presence of EARR measured in 3D Cone bean computed tomography (CBCT)
次要结局
- PROMs(72 h and 15 days)
- Percentage of residual pockets (PD>4 mm).(6 months)
- Soft tissue thickness by PIROP ultrasound scanner(6 months)
- Adverse events (AEs)(During the study duration (6 months))
- Gingival microvasculature(6 months)