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临床试验/NCT05722509
NCT05722509招募中不适用

Evaluation of a Periodontal Pocket Reduction Technique Applied to Exodontia of Erupted or Semi-erupted Wisdom Teeth

Universidad Rey Juan Carlos2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
Probing depth

研究概览

简要总结

On many occasions, clinicians find situations in which they have to perform extractions of erupted or semi-erupted third molars or wisdom teeth where there are pre-existing periodontal pockets distal to the second molars, caused by a bone defect due to periodontal disease or due to malposition of the wisdom tooth concerning the second molar.

After the extraction of an erupted or semi-included third molar, and as a consequence of factors related to dental malposition or bone defects caused by periodontal disease, periodontal pockets can arise on the distal surface of the second molar.

When such exodontia is performed conventionally without raising a flap or applying any suturing technique in which there is a primary closure of the wound, there is a greater probability of persistence of periodontal pockets; and, in the worst case, they may increase after healing and closure of the alveolus. The consequence would be the formation of an enlarged and unattached tissue on the distal aspect of the second molar.

The fact that periodontal pockets persist acts as an unfavorable prognostic factor. The predictive power of subsequent periodontal destruction increases since these are areas where bacteria will continue to accumulate (etiological factor of periodontal disease), and where the patient will not be able to access for their elimination and control. This is why a surgical technique called "distal wedge" has been proposed to eliminate these pockets.

To avoid this second surgical procedure, we propose a procedure immediately after the conventional exodontic technique; where after performing a small gingivectomy and lifting a mucoperiosteal flap based on periodontal respective surgery concepts, primary closure of the alveolus and repositioning of the flaps at the level of the bone crest is achieved, eliminating these pre-existing pockets. This requires the existence of sufficient keratinized gingiva to maintain a band of at least 2 mm of keratinized tissue after the gingivectomy, thus ensuring a correct adherent tissue that provides sealing and proper maintenance of the periodontal tissues around the tooth. The proposed technique has been termed a "distal reduction flap" (DRF).

详细描述

The study population will be the patients of the University Clinic of the Rey Juan Carlos University of Madrid.

A non-probabilistic selection method will be used in the Master's Degree in Periodontology and Osseointegration and the Integrated Adult Clinical Dentistry course, for those patients who meet the inclusion criteria for the study.

Patients will be assigned to the experimental and control groups by probabilistic methods using a table of random numbers.

Variables:

Independent Variable: Surgical technique. In the experimental group, the Distal Reduction Flap (DRF) technique and primary wound closure will be used. In the control group, the conventional exodontic technique and secondary wound closure will be used.

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

Pre-measurements will be performed by 2 previously calibrated examiners (R.R.P and J.R.M). The calibration will consist of evaluating the periodontal probing of 10 patients in the mesial, distal, vestibular, and palatal/lingual areas and comparing the results of both examiners until an excellent degree of agreement is achieved. The surgical procedure will be performed by the principal investigator (RRM). Measurements of the results in the different study periods will be performed by a third independent evaluator (JFF) who will be blinded.

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

  • Patients who require third molar extraction and who have periodontal pockets distal to the adjacent second molars.
  • In the second molars there should be enough keratinized gingiva to allow for a buccal and/or lingual-palatal buckle (minimum residual band of 2 mm).
  • Patients of either sex.
  • Patients over 18 years old.
  • Healthy patients or in a controlled periodontal situation (previously treated with basic periodontal therapy with scaling and root planing with probing depths of less than 4 mm and bleeding index at probing <25%).
  • In the case of pharmacologically treated patients, they should be properly controlled and request prior consultation to evaluate pharmacological treatments that may lead to hematological alterations.

排除标准

  • Patients with uncontrolled pathologies or systemic conditions.

结局指标

主要结局

Probing depth

时间窗: 6 and 18 weeks

changes in probing depth

次要结局

  • Post-operative pain(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosario María Ramírez Puerta

Clinical Professor

Universidad Rey Juan Carlos

研究点 (2)

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