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临床试验/NCT07380126
NCT07380126尚未招募不适用

The Effect of Functional Crown Lengthening Versus Deep Margin Elevation on Periodontal Tissues (A Randomized Clinical Trial With Biochemical Analysis)

Ain Shams University0 个研究点目标入组 20 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Probing depth

研究概览

简要总结

The present study will evaluate and compare the effect of functional CL and DME in the treatment of posterior teeth with class II caries clinically and on the level of TNF-α in the GCF of treated teeth.

Clinical evaluation of periodontal tissue in the form of probing depth as a primary outcome, clinical attachment level, plaque index, bleeding index, gingival index, pink aesthetic score, Radiographic evaluation of biological width and the level of TNF-α in the GCF as a secondary outcome.

详细描述

In dental practice, restoring cavitated proximal caries lesions is a common routine procedure in dental clinics. However, subgingival margins reaching below the cementoenamel junction are known to have a common clinical concern, especially when restoring severely destructed Class II caries. Ideally, the correct choice of treatment plan is critical to ensure successful outcomes (Padbury et al., 2003).

The use of direct adhesive restoration to restore large interproximal defects is not an ideal treatment option. Due to their size, such defects usually require indirect adhesive restorations. However, this appears to be challenging since cavity preparation, impression taking, the adhesive-bonding procedure, and proper moisture control may be impeded. These challenges are usually overcomed by functional crown lengthening (Mangani et al.,2015; Juloski et al.,2018).

Functional Crown lengthening is a surgical procedure to expose the gingival margins by apical displacement of the supporting periodontal structures, thus can facilitate an access and adequate isolation to achieve the optimum position of deep restorations and avoid violating the biological width (Magne & Spreafico, 2012; Sarfati & Tirlet, 2018).

The biological width is defined as the gingival attachment along the root surface, from the most coronal portion of the epithelium attachment to the most apical portion of the connective tissue attachment (Gargiulo et al.,1961). Therefore, a recommended distance of 3 mm or more between the restorative margins and the alveolar crest is considered necessary to avoid detrimental effects on neighbouring soft and hard periodontal tissues (Ingber et al.,1977; Lanning et al., 2003). The violation of the biological width results in severe gingival inflammation and consequently deep pocket formation or gingival recession, in addition to bone level reduction (Nugala et al., 2012).

Recurrence usually occurs particularly in patients with thick biotypes or when surgery comprises only gingivectomy. Moreover, recurrence leads to restoration limits being replaced sub-gingivally, whereas surgery aims to place them sub-gingivally (Ganji et al.,2012)..

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 (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20-50 years
  • Both genders
  • Patients free from any systemic disease that may affect the treatment (Greenberg & Glick, 2012)
  • Patients with intact periodontium
  • Patients are ready to comply with oral hygiene measures.
  • Patients having Posterior teeth with carious cavities and/ or restorations in need of replacement on proximal surfaces, where the cervical margin of the cavity is at a distance less than 3 mm to the bone crest (Cyana et al.,2013).
  • Patients with thick phenotype having gingival thickness > 1mm (Aimetti et al,2008).
  • Patients with keratinized tissue width ≥ 2mm

排除标准

  • Pregnant and lactating females
  • Drug abusers.
  • Patients with persistent poor oral hygiene
  • Patients with proximal margins beyond the bone level
  • Patients with developmental dental anomalies
  • Patients undergoing or will start orthodontic treatment

研究组 & 干预措施

Functional crown lengthening

Experimental

patients will undergo functional crown lengthening by raising a full thickness flap with osseous resection to establish a distance of 3 mm between the cervical margin of the cavity and the bone crest. Osteoplasty was performed in the adjacent and neighboring tooth surfaces to accomplish a smooth bone contour. The flaps will then be sutured in their new position

干预措施: Functional Crown lengthening (Procedure)

Deep Margin Elevation

Active Comparator

patients will undergo deep margin elevation through a two-step direct restoration performed using the concepts of Progressive Matrixing and Wedging where the Deep subgingival cavity margin will be acquired. Then isolation by rubber dam. A curved matrix will seal the margin without any gingival or rubber dam entrapped in between. One step adhesive system will be performed under rubber dam isolation. Composite resin base is applied to raise the margin by about 2 mm. A bulk fill packable or flowable composite can be used. Finishing will be done using polishing strips and disks. Finally a bitewing radiograph will be taken to check the presence of overhangs or gaps before the final restoration.

干预措施: Deep Margin Elevation (Procedure)

结局指标

主要结局

Probing depth

时间窗: Clinical measurements preoperative and will be repeated at 1, 3, and 6 months

Will be measured from the gingival margin to the depth of the pocket at four points (mesio-facial, mid-facial, disto-facial and mid-lingual) to the nearest millimeter using UNC-15 periodontal probe. The average of the three facial points will be recorded as the facial probing depth (FPD), while the mid-lingual point will be recorded as the lingual probing depth.

次要结局

  • Biochemical evaluation(Biochemical measurements preoperative and will be repeated at 1, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

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