Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Reduction in the gingival margin
研究概览
简要总结
When performing crown lengthening surgery, especially in the esthetic zone, the positional stability of gingival tissues is considered a prime important goal. The rebound of gingival margins after surgery can result in compromising the esthetic outcome and patient satisfaction. It was proven throughout the literature that there are many factors that may influence the stability of gingival margin position after surgery such as: the surgical technique being performed, experience of the clinician, periodontal phenotype and distance of flap with respect to the alveolar crest.
详细描述
A "gummy smile" or excessive gingival display (EGD) is when at least 3-5 mm of gingiva is visible. It is viewed as unnatural or unsightly, and in order to have the best outcome, cosmetic periodontal recontouring is frequently necessary. It is considered the treatment of choice for excessive gingival display, or "Gummy smile,". Many causes of gummy smiles have been found, including altered passive eruption, short upper lip, dentoalveolar extrusion, abnormal vertical bone growth, and a combination of some of these.
Altered passive eruption is when the gingival margin is located incisal to the cervical convexity of the crown and away from the cemento-enamel junction of the tooth. It is considered the most frequent related factor, accounting for between 12.1 and 35.8% of excessive gingival display cases that have been identified, according to evidence.
Considering esthetic crown lengthening (ECL) surgery, the goal is to restore the gingival harmony and symmetry by reestablishing the proper clinical crown length. However, stability of the periodontal tissues after ECL is a crucial aspect that can be jeopardized the treatment outcome of the treated region. In particular, gingival margin rebound can impair aesthetics and have an impact on the health of periodontal tissue
Predicting the amount of tissue rebound after esthetic crown lengthening surgery is still controversial. According to literature, there is a tendency to have a gingival regrowth from the immediate postoperative level for up to 3 months. It has been also confirmed that rebound of gingival margin most likely occurs during the first three months following surgery. Another study found that the gingival margin had coronal migration may continue for up to 6-12 months after surgery.
Based on current evidence, gingival margin rebound is a major issue that happens after performing crown lengthening surgery. To avoid this, GingivalStat approach has been proposed to guide the tissue after surgery to remodel early at a predetermined position and avoid the re-growth of gingiva in a coronal direction. It appears to be producing earlier stability. The current study aims to investigate the influence of GingivalStat following crown lengthening versus conventional crown lengthening, in terms of stability of gingival margin.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Altered Passive Eruption Subtype B presenting altered alveolar bone crest-CEJ relationship according to Coslet's et al. classification.
- •Patients free of systemic diseases.
- •Patients aged between 18 to 60 years old.
- •Patients maintaining good oral hygiene with full-mouth plaque and bleeding scores <15%.
- •Patients should be committed to the post-operative care regime, including oral hygiene practices, and follow-up visits.
排除标准
- •Areas in which the remaining amount of keratinized gingiva after the submarginal incision will be less than 3 mm.
- •Patients with periodontal disease.
- •Pregnant women.
- •Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radiotherapy)
研究组 & 干预措施
Interventional group (Gingival Stat approach -- Composite stops after ECL surgery)
Steps 1-6 as Active Comparator group + 7. Resin composite wil be placed on the cervical third of the teeth, following the CEJ anatomy, to act as a gingival stabilizer to guide the early remodelling of tissues.
8. Removal of sutures and composite after two weeks.
干预措施: Esthetic Crown Lengthening using GingivalStat approach (Procedure)
Control group (Conventional ECL surgery)
- Following the administration of local anaesthesia, a submarginal internal bevelled incision using 15c blade will be carried out, from canine to canine. The distance from the gingival margin will be based on how much soft tissue needs to be removed to meet the ideal tooth proportion.
- Intrasulcular incision will be done in the buccal aspect and papilla region for removal of tissue collar.
- A full thickness mucoperiosteal flap will be elevated using mucoperiosteal elevator, without bypassing the MGJ.
- To obtain a 3 mm distance between CEJ and bone, osteoctomy wil be carried out from line angle to line angle using high speed hand piece with end-cutting bur.
- Osteoplasty using round bur, maybe done to reduce bone thickness and obtain adequate anatomical profile.
- After the flap is repositioned, interrupted sutures using Polypropylene 5-0 will be used to adapt and suture the flap in its new position.
干预措施: Esthetic Crown Lengthening (Procedure)
结局指标
主要结局
Reduction in the gingival margin
时间窗: Baseline, immediate post operative, 2 weeks, 3 months and 6 months
Gingival margin position wil be measured using UNC periodontal probe + stent. Grooves will be made in the stent to standardize probe direction and localization. Each tooth will be assessed on the mesio-buccal, mid-buccal, and disto-buccal aspect at baseline, immediate post operative, 2 weeks, 3 months, and 6 months.
Stability of relative gingival margin position
时间窗: Baseline, immediate postoperative, 2 weeks, 3 months and 6 months
Gingival margin position will be measured using Intra-oral digital Scan (IOS). It will be measured at baseline, immediately after surgery, 2 weeks, 3 months and 6 months. Scans will be superimposed to detect all changes throughout the follow up period.
次要结局
- Pink Esthetic Score by blinded assessment(At 3 months and 6 months)
- Postsurgical pain assessment(At two weeks.)
- Patient satisfaction(Two weeks, three months and six months)
- Cost effectiveness(At six months.)
- Procedural Time(At the surgery)
研究者
Ahmad Elganayni
Principal investigator
Cairo University