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临床试验/NCT06611735
NCT06611735已完成不适用

The Effect of Retentive Rubber-Dam Clamps on Gingival Tissues During Restorative Treatment

Marmara University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Measurement of plaque index before the treatment

研究概览

简要总结

This study aims to evaluate the effect of retention rubber dam clamps used on premolar teeth during rubber dam isolation on gingival health. The teeth to which retention clamps are applied were not undergo any restorative procedures. Retention clamps applied to maxillary premolars during routine rubber dam isolation for performing anterior restorations. Changes in periodontal tissues were evaluated; using plaque index, bleeding on probing, probing depth, keratinized gingiva, attached gingiva, relative gingival margin level and relative attachment levels after the procedure at different times (pre-restoration, after restoration, 1 week, 1 month, 3 month). The evaluation time was planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department.

详细描述

In the present study, it is aimed to evaluate the effect of retention rubber dam clamps used on premolar teeth during rubber dam isolation on gingival health. The teeth to which retention clamps are applied were not undergo any restorative procedures. Retention clamps applied to maxillary premolars during routine rubber dam isolation for performing anterior restorations. The application time of the retention clamps were limited as maximum 2 hours. Before starting the treatment, patients signed information and consent forms. In the present study, direct composite restorations were planned under local anesthesia, and it was planned to evaluate the effects of retention clamps on periodontal tissues and patient comfort. After the isolation, direct composite restorations were performed.

  • Data collection method Changes in periodontal tissues were evaluated; using plaque index, bleeding on probing, probing depth, keratinized gingiva, attached gingiva, relative gingival margin level, relative attachment level after the procedure at different times (pre-restoration, after restoration). It was evaluated immediately after, 1 week later, 1 month later, 3 months later. The evaluation time was planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department.

Restorative materials used in the study; Nic Tone Thick (Dental Dam, Nic Tone, Romania) was used as a rubber-dam rubber cover for patients. In addition, sterile frames (Hu-Friedy Group, USA), forceps (Hu-Friedy Group, USA) and puncher (Hu-Friedy Group, USA) were used as rubber-dam instruments on patients. For gingival retention, Hu-Friedy Black Line 2X clamps (Hu-Friedy Group, USA) were used.

Clinical Index and Measurements Determination of Gingival Phenotype Evaluating the visibility of the silhouette of the periodontal probe inserted into the sulcus is a technique used to determine the phenotype. If the silhouette of the probe placed in the sulcus is visible, the gingiva is considered thin, and if it is not, the gingiva is considered thick.

Keratinized Gums The distance between the mucogingival junction and the gingival margin were measured as the width of the keratinized gingiva after the alveolar mucosa was pushed and curved coronally and with periodontal probe and the mucogingival junction was determined.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Have sufficient cognitive ability to understand the consent procedure
  • Clinically healthy gingiva and periodontium
  • Daily cigarette consumption of 10 or less
  • No attachment loss, bleeding on probing, or plaque buildup
  • Patients with cervical lesions, abrasion lesions and/or indications for diastema closure requiring restoration
  • Patients with cervical lesions at or below the gingival level
  • Patients with direct composite restoration indications concerning the anterior region.

排除标准

  • Any disability (mental health conditions, mentally handicapped and physically handicapped)
  • Systemic diseases or serious medical risks (Cardiovascular disorder, diabetes, hypertensive, epileptic)
  • Compliance problem, inability to provide post-treatment hygiene
  • Gingival hyperplasia or bleeding disorder
  • Signs of attachment loss of periodontal disease
  • Patients for whom rubber dam placement is contraindicated (patient with asthma diagnosis, mouth breathing, partially erupted tooth, overly malpositioned teeth and latex allergy).
  • Signs of periapical pathology or pulpal posterior or anterior pathology
  • Teeth which have mobility
  • Teeth with extraction indication

结局指标

主要结局

Measurement of plaque index before the treatment

时间窗: Before the treatment

For each tooth, plaque index measurements were made from 4 regions as mesiobuccal, midbuccal, distobuccal, midpalatinal.

Measurement of probing depth before the treatment

时间窗: Before the treatment

For each of the initially selected teeth, probing depth measurements were made in a total of 6 regions: mesiobuccal, midbuccal, distobuccal, mesiopalatinal, midpalatinal, and distopalatinal surfaces.

Measurement of bleeding on probing before the treatment

时间窗: Before the treatment

Bleeding on probing was examined in 6 regions of each tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatinal, midpalatinal, and distopalatinal. (+) or (-) values will be given according to the presence or absence of bleeding that occurs after the Unc (University of North Carolina) probe examination.

Measurement of keratinized gingiva before the treatment

时间窗: Before the treatment

The distance between the mucogingival junction and the gingival margin was measured as the width of the keratinized gingiva after the alveolar mucosa was pushed and curved coronally and with periodontal probe and the mucogingival junction was determined.

Measurement of attached gingiva before the treatment

时间窗: Before the treatment

The distance between the mucogingival junction and the floor of gingival sulcus was measured as the width of the attached gingiva.

Measurement of relative gingival margin level before the treatment

时间窗: Before the treatment

Using the Chu\'s Gauge handpiece, it was placed on the incisal edge of the incisors, the incisal guide edge of the handpiece was taken as the fixed guide point, and the distance between the incisal guide and the gingival margin was measured and recorded. Relative gingival margin level measurement was made in a total of 3 regions of each tooth: mesiobuccal, midbuccal, and distobuccal surfaces.

Measurement of relative attachment level before the treatment

时间窗: Before the treatment

Using the Chu\'s Gauge handpiece, it was placed on the incisal edge of the incisors, the incisal guide edge of the handpiece was taken as the fixed guide point, and the distance between the floor of gingival sulcus and the incisal guide edge was measured and recorded with a periodontal probe. Relative attachment level measurement will be made in 3 regions, mesiobuccal, midbuccal, distobuccal surfaces of each tooth.

次要结局

  • Measurement of probing depth immediately after the treatment(Immediately after the treatment)
  • Measurement of bleeding on probing immediately after the treatment(Immediately after the treatment)
  • Measurement of keratinized gingiva immediately after the treatment(Immediately after the treatment)
  • Measurement of attached gingiva immediately after the treatment(Immediately after the treatment)
  • Measurement of relative gingival attachment level immediately after the treatment(Immediately after the treatment)
  • Measurement of relative gingival margin level immediately after the treatment(Immediately after the treatment)
  • Measurement of plaque index of 1 week control session(1 week after the treatment)
  • Measurement of probing depth of 1 week control session(1 week after the treatment)
  • Measurement of bleeding on probing of 1 week control session(1 week after the treatment)
  • Measurement of keratinized gingiva of 1 week control session(1 week after the treatment)
  • Measurement of relative gingival margin level of 1 week control session(1 week after the treatment)
  • Measurement of attached gingiva of 1 week control session(1 week after the treatment)
  • Measurement of relative attachment level of 1 week control session(1 week after the treatment)
  • Measurement of plaque index of 1 month control session(1 month after the treatment)
  • Measurement of probing depth of 1 month control session(1 month after the treatment)
  • Measurement of bleeding on probing of 1 month control session(1 month after the treatment)
  • Measurement of keratinized gingiva of 1 month control session(1 month after the treatment)
  • Measurement of attached gingiva of 1 month control session(1 month after the treatment)
  • Measurement of relative gingival margin level of 1 month control session(1 month after the treatment)
  • Measurement of relative attachment level of 1 month control session(1 month after the treatment)
  • Measurement of plaque index of 3 months control session(3 months after the treatment)
  • Measurement of probing depth of 3 months control session(3 months after the treatment)
  • Measurement of bleeding on probing of 3 months control session(3 months after the treatment)
  • Measurement of keratinized gingiva of 3 months control session(3 months after the treatment)
  • Measurement of attached gingiva of 3 months control session(3 months after the treatment)
  • Measurement of relative gingival margin level of 3 months control session(3 months after the treatment)
  • Measurement of relative attachment level of 3 months control session(3 months after the treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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