跳至主要内容
临床试验/NCT07401667
NCT07401667已完成不适用

Efficacy of Connective Tissue Graft Versus Titanium Papillary Inserts in the Surgical Reconstruction of Interdental Papilla

Dr R Viswa Chandra1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年5月21日最近更新:
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
18
试验地点
1
主要终点
Interdental papilla height

研究概览

简要总结

Aim and Objectives: The study aimed to evaluate the effectiveness of titanium inserts for interdental papilla reconstruction, comparing it with the Han and Takei technique using subepithelial connective tissue grafts. The objectives included assessing the black triangle height, papilla height and papilla presence index (PPI) at baseline, 1 month and 3 months post operatively along with the evaluation of Early Wound Healing Score (EHS) during the first week of post operative healing period. Patients and Methods: This single-blind randomized clinical trial included systemically healthy individuals aged 18-35 years with Nordland and Tarnow's Class I-III papillary loss. A total of 18 participants were randomly assigned to either test group or control group. Clinical parameters were measured pre- and post-operatively at specified intervals. Both groups received standard presurgical care and postoperative follow-up. The surgical protocol for the test group involved titanium insert placement in the interdental bone, while the control group received a connective tissue graft using the Han and Takei method.

详细描述

INTRODUCTION The human gingiva consists of specific anatomical components: the attached gingiva, which securely connects the gingiva to the underlying bone, and the marginal (free) gingiva, a slender strip of tissue that surrounds the tooth without adhering to hard tissue. Vertically, the marginal gingiva stretches from the (Cemento-enamel junction) CEJ to the free gingival groove. In the interdental space lies the interdental papilla, a vital part of the gingival structure.1,2 Morphologically, the interdental papilla reaches from the interdental alveolar bone to the contact point of neighboring teeth. It is separated from the mesial and distal aspects by sulcular and/or junctional epithelium, whereas the facial and oral surfaces are covered by keratinized gingival oral epithelium. The development of the interdental papilla takes place during tooth eruption, and its shape is affected by the contact points of neighboring teeth, the widths of proximal tooth surfaces, and the configuration of the CEJ.1,2 The interdental papilla can be vulnerable to inflammatory agents through the junctional/sulcular epithelia, leading to localized inflammation even in clinically healthy papillae, which is a frequently observed histologic finding.

A black triangle, which denotes the loss of interdental papillae, continues to be one of the most prevalent conditions leading to not just aesthetic and phonetic issues but also functional challenges as it increases the likelihood of food impaction that negatively impacts periodontal health. The interdental papilla in the incisor area is typically pyramidal in form. Elements that affect the presence or absence of interdental papilla include crestal alveolar bone height, the dimensions of the interproximal space, soft tissue appearance (thick or thin biotype), buccal plate thickness, the type of contact area (triangular versus square), and the biologic width.3 The limited ability of the interdental papilla to regenerate seems to be influenced by various aspects, such as anatomical factors, bone loss, plaque accumulation, and inflammatory phenomena within the interdental area. Moreover, there is an indication that the interdental papilla may have unique functional features resulting from specific cellular or molecular attributes. This idea is supported by ample documentation showing that distinct anatomical tissue units, even within the marginal gingiva, display specific characteristics. 4-9 A range of techniques has been investigated for reconstructing the interdental papilla, encompassing both nonsurgical and surgical strategies. Among the nonsurgical techniques are repeated curettage of the interdental papilla, orthodontic adjustments, restorative fixes, and the application of hyaluronic acid (HA). Although these methods have been tried, they frequently produce less reliable results and provide limited potential for considerable papilla enhancement.

Conversely, surgical approaches have become more prominent due to their effectiveness in papilla reconstruction, despite being more invasive and complex. These surgical options consist of pedicle and free gingival grafts, connective tissue grafts (CTG), subepithelial connective tissue grafts (SCTG), and the application of Choukroun's platelet-rich fibrin (PRF). These techniques involve the manipulation of gum tissues to improve the height and shape of the interdental papilla, targeting more reliable and satisfactory aesthetic results.10 Titanium alloys are highly regarded for their outstanding strength-to-weight ratio, resistance to corrosion, and biocompatibility, which makes them suitable for aerospace, medical implants, and marine uses. Their ability to resist oxygen, water, and chemicals guarantees durability in harsh conditions, while their non-toxic nature makes them ideal for medical applications. The characteristics of titanium alloys can be customized through alloying, heat treatment, and surface modifications to satisfy specific application demands.11 El Askary et al (2000)12 described the papillary titanium insert and emphasized its benefits, manipulation, and handling. To support the soft tissue between two implants and achieve the desired interdental papilla-like form, a papillary titanium insert was created. This method eliminates the necessity for any bone grafting procedures while requiring fewer tools and reducing the number of surgical interventions.

This study seeks to present the use of a titanium insert for reconstructing the interdental papilla, which was previously utilized by El Askary et al12 for forming inter-implant papillae. It also intends to compare this method with the Han and Takei technique13 of papilla reconstruction using a subepithelial connective tissue graft. The research findings hold the potential to provide clinicians with an innovative therapeutic alternative for enhancing periodontal aesthetics and increasing patient satisfaction.

MATERIAL AND METHODS

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)

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

  • Systemically healthy male and female patients with a stable periodontal health of age 18-35 years.
  • Patients with Nordland and Tarnow's1 Class I, II, III interdental papillary loss at a single site and Gingival recession < 2 mm on the facial aspect.
  • Patients presenting with adequate width of attached gingiva (2-3mm)
  • Having a thick gingival biotype (2 mm)

排除标准

  • Midline diastema patients
  • Medically compromised patients
  • Pregnant and lactating women
  • Heavy smokers,
  • Patient who underwent radiotherapy & chemotherapy,
  • Patients with any bleeding or clotting disorders
  • Patients not willing to participate in the study.

研究组 & 干预措施

TITANIUM INSERTS FOR PAPILLA RECONSTRUCTION

Experimental

干预措施: TITANIUM INSERTS (Device)

SUB-EPITHELIAL CONNECTIVE TISSUE GRAFT FOR PAPILLA RECONSTRUCTION USING HAN & TAKEI TECHNIQUE

Active Comparator

干预措施: CONNECTIVE TISSUE GRAFT (Procedure)

结局指标

主要结局

Interdental papilla height

时间窗: 3 MONTHS

To be measured from base of the papilla (a line joining the two adjacent teeth gingival zenith) to the tip of the papilla. Measured with UNC-15 probe.

Black triangle height

时间窗: 3 MONTHS

Measurement from the tip of the interdental papilla to the apical-most point of the contact point. Measured using a digital vernier caliper.

Papilla presence index (PPI)

时间窗: 3 MONTHS

given by Cardaropoli et al

次要结局

  • Early Wound Healing Score (EHS)(1 WEEK)

研究者

发起方
Dr R Viswa Chandra
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr R Viswa Chandra

PROFESSOR AND HEAD OF DEPARTMENT

SVS Institute of Dental Sciences

研究点 (1)

Loading locations...

相似试验