Periodontal Phenotype and Supracrestal Soft Tissue Dimentions - Clinical Correlations and Their Impact on Post-extraction Volumetric Changes

Gustavo Avila-Ortiz DDS, MS, PhD1 个研究点分布在 1 个国家目标入组 42 人开始时间: 2016年1月31日最近更新: 2022年11月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 42
试验地点: 1
主要终点: Percentage change in tissue volume - Rank Correlations

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this trial is to determine the correlations between various tissue dimensions and the changes that occur following a single-tooth dental extraction in human adults.

65 adult subjects who are in need of dental extractions will be recruited. Clinical measurements will be gathered prior to and immediately following the single tooth extraction. There will be a 2-week post-operative visit to assess healing and a 14-week follow-up for photographic documentation and clinical measurements of the extraction area.

详细描述

Periodontal phenotype, also known as periodontal biotype, has been recognized as one of the key factors that may potentially impact the outcome of a variety of esthetic restorative procedures. With the increasing esthetic demand of patients in the context of tooth replacement therapy in the anterior esthetic zone, the ability to determine the prognostic value and the influence on treatment outcomes of this parameter has become a critical component of contemporary treatment planning. Periodontal phenotype encompases "bone morphotypes, shapes of the teeth, morphologic characteristics of the gingiva and the periodontium".

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Age: 18 to 75 years
•Gender: No restriction
•Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless) in the maxillary anterior region (first premolar to first premolar)
•Subjects must be able and willing to follow instructions related to the study procedures
•Subjects must have read, understood and signed an informed consent form

排除标准

•More than 1 mm of recession present on the tooth planned for extraction and inclusion in the study
•Reported allergy or hypersensitivity to any of the products to be used in the study
•Severe hematologic disorders, such as hemophilia or leukemia
•Active severe infectious diseases that may compromise normal healing
•Liver or kidney dysfunction/failure
•Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
•Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or more)
•Subjects with a history of IV bisphosphonates
•Subjects with uncontrolled diabetes, defined as Hba1c > 7.0
•Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded
•Pregnant women or nursing mothers
•Heavy smokers: Subjects who have smoked >10 cigarettes per day within 6 months of study onset
•Concomitant medications: Subjects on concomitant drug therapy for systemic conditions that may affect the outcomes of the study will not be included in the study.
•NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.
•Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).