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临床试验/NCT06081296
NCT06081296招募中不适用

Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: Randomized Controlled Trial

Renato Casarin2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
assessment of dimensional change using linear measurements through CT, evaluating bone remodeling.

研究概览

简要总结

Objective: The objective is to evaluate the dimensional changes of soft tissue and alveolar ridge after extraction of posterior elements with different clinical protocols of alveolar preservation.

详细描述

Detailed methodology: 80 individuals will be selected with need for extraction of premolar and molar elements, from both arches, for non-periodontal reasons, to participate in this randomized controlled clinical study. The dental elements will be extracted atraumatically, and allocated to one of the study groups (n=20/grp): Control Group (Ctl): alveolus closure with total flap elevation and simple suture; Group Free Gingival Mixed Graft (EGLM): closure of the alveolus without flap elevation, and placement of a mixed free gingival tissue graft (epithelialized in the central region and de-epithelialized (2 mm) in the vestibulolingual edges;

Bone + Mixed Free Gum Graft Group (B+EGLM): socket closure without flap elevation, placement of lyophilized bone graft and socket sealing with mixed free gingival tissue graft (as previously described);

Bone + Titanium Seal Group (B+TS): socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane. Immediately after the extractions, Cone Beam Computed Tomography (90 kVp/8 mA/2.3 sec) will be performed, with lip/cheek separation, with 1.5 mm thick slices and a 1 mm distance, with a field of vision (FOV) of 5±5 cm, which will be repeated after 6 months. During the CT scans, the patients will use intra-oral appliances with hyperdense indicators to determine the reference points to measure the variables: bone tissue height in the center of the socket (primary variable) and every 2 mm equidistantly; thickness of bone tissue in the center of the socket and every 2 mm equidistantly. Soft tissue variables will also be evaluated, such as: mucosal thickness at the height and 2 mm below the edge margin (by CT); height of the keratinized tissue (measured by a dry tip caliper). After 6 months, all patients will receive dental implants, with the ideal measurements for bone dimension, and the possibility of installing implants >10mm or <10mm in length will be statistically analyzed. After 4 months of dental implant placement, single prostheses will be installed and CT, soft tissue measurements and clinical parameters will be repeated (peri-implant depth; presence of biofilm and bleeding on probing; tissue thickness at the margin and 2 mm below; keratinized tissue). Implants will be re-evaluated after 12 months. All measurements will be performed by a previously calibrated examiner (intra-class correlation above 90%). The data will initially be analyzed in a descriptive way, with means and standard deviations. For comparison between groups and times, two-way/Tukey ANOVA test will be used. In all analyses, a significance level of 5% will be considered.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Randomization by electronically generated list; Different examiners than operator; Bliding patient;

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systemic health (Hypertension and Diabetes controlled)
  • Indication of tooth extraction with at least 2/3 of the bone support, in the premolar or molar region
  • Signing the consent form
  • Individuals over 18 years of age.

排除标准

  • Presence of periodontal disease at the time of surgery
  • Pregnant and lactating women
  • Being in orthodontic treatment
  • Use medication that alters the bone healing process, such as those used to treat osteoporosis and the bisphosphonate group
  • Individuals under 18 years of age

结局指标

主要结局

assessment of dimensional change using linear measurements through CT, evaluating bone remodeling.

时间窗: 6 months

Through CT taken immediately after tooth extraction and six months later, these images will be analyzed to evaluate changes in hard tissues

次要结局

  • evaluation of the dimensional change of soft tissues that accompany bone remodeling through linear and volume measurements in the STL(6 months)
  • Visual analogy scale for pain and disconfort evaluattion which consists of a score to measure the patient's pain intensity.(1 week)

研究者

发起方
Renato Casarin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Renato Casarin

Associated Professor

University of Campinas, Brazil

研究点 (2)

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