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临床试验/NCT06314256
NCT06314256已完成4 期

Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction

Altinbas University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年4月10日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
13
试验地点
1
主要终点
Black Triangle Area

研究概览

简要总结

The goal of this clinical trial is to evaluate and compare the efficacy of injectable platelet rich fibrin (i-PRF) and hyaluronic acid (HA) in reconstruction of interdental papilla loss. The main questions it aims to answer are:

  • How compareable are above mentioned two interventions (i-PRF&HA) in reconstruction of interdental papilla loss?
  • Which treatment option is better accepted by patients? Which treatment option would patients be more satisfied with? Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design. Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes, for how long do they last.

详细描述

Nowadays, individuals give great importance to their appearance and dental aesthetics plays a key role in their personal appearance. Dental aesthetics is a combination of white and pink aesthetics formed by teeth and gums. The part of the gingival tissue that fills the triangular shaped spaces between the teeth is the interdental papilla. The presence of papillae in the teeth is closely related to the distance between the contact point between the teeth and the alveolar bone crest. Periodontal diseases, traumatic oral hygiene practices, incorrect orthodontic forces, incompatible restoration contour, the presence of diastema as a result of neighbouring teeth not being in contact, and tooth loss can cause loss of interdental papillae, resulting in the formation of gaps called black triangles. In addition to aesthetic problems, loss of interdental papillae can cause speech difficulties and food impaction.

Interdental papilla loss is one of the most important aesthetic periodontal difficulties and at the same time one of the most difficult problems to treat. Various surgical methods and flap designs have been proposed for the treatment and reconstruction of interdental papillae. However, current surgical methods have limited success and lack predictability, especially because the gingival papilla has a sensitive structure and less blood supply compared to other parts of the gingiva. Therefore, non-surgical methods have gained importance. As a result of the development of tissue engineering, dermal filling materials have started to be produced in recent years. Among these materials, hyaluronic acid (HA) is one of the basic components of connective tissue and especially its water binding/retention property makes it a determinant of tissue volume. HA enables the migration of fibroblast cells involved in collagen production and also acts as a liquid matrix where collagen and elastic fibres will proliferate. Due to these properties, Becker et al. first demonstrated in 2010 that it was possible to reconstruct a small area of interdental papilla loss in a minimally invasive and predictable manner using injectable HA gel. Subsequently, HA injections in interdental papil reconstructions have frequently been successfully reported in the literature.

Platelet Rich Fibrin (PRF) is an autologous, membrane-form product prepared by centrifugation of the patient's own blood. This fibrin matrix containing platelets, leukocytes and various growth factors is used especially in regenerative periodontal surgical operations. Injectable PRF (i-PRF), obtained by modifying the preparation protocol, forms a dynamic hydrogel by increasing the number of cells and releasing growth factors more frequently. I-PRF serves as a source of slow-release growth factors that help remodelling of the interdental papilla. Using data obtained through standardised photographs, the project will evaluate the effectiveness of area closure rates of black triangles caused by papilla loss over a 3-month period and measure patient feedback and satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participant will be masked, which side of her/his mouth will be treated with either i-PRF or HA. The outcome assessor is blinded to the treatment modalities.

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

  • Systemically healthy (without cardiovascular diseases, diabetes, thyroid diseases, auto-immune diseases)
  • Patients with PPI 2 and PPI 3 papillae according to the Papillary Presence Index classification
  • Probable pocket depth of 4 mm or less in the relevant area
  • Plaque index and gingival index in the range of 0-1
  • Neighbouring teeth in contact with each other in the relevant area
  • Absence of any restoration in the relevant area
  • Non-smoker
  • No surgical periodontal treatment in the last 6 months
  • For female subjects not pregnant or lactating
  • No known allergy to hyaluronic acid

排除标准

  • Not systemically healthy (with cardiovascular diseases, diabetes, thyroid diseases, auto-immune diseases)
  • Diagnosed with periodontitis
  • History of allergic reactions to hyaluronic acid
  • Less than 2 mm keratinized tissue height in the relevant area
  • Teeth crowding in relevant area
  • Any kind of restoration (fillings, crowns, etc.) in the relevant area
  • Ongoing orthodontic treatment
  • Having parafunctional habits (bruxism, etc.)

研究组 & 干预措施

Injectable PRF

Active Comparator

i-PRF is produced by cenrifugation of patients own blood. Injection of 0.1-0.2 ml per interdental papilla 3 times with 3-week interval.

干预措施: I-PRF Injection (Biological)

Injectable PRF

Active Comparator

i-PRF is produced by cenrifugation of patients own blood. Injection of 0.1-0.2 ml per interdental papilla 3 times with 3-week interval.

干预措施: Teosyal PureSense Global Action HA Injection (Drug)

Hyaluronic Acid

Active Comparator

Teosyal® Global Action PureSense. Composition: Cross-linked hyaluronic acid (HA): 25 mg/ml Lidocaine; 0,3%, (injection).

Injection of 0.1-0.2 ml per interdental papilla 3 times with 3-week interval.

干预措施: I-PRF Injection (Biological)

Hyaluronic Acid

Active Comparator

Teosyal® Global Action PureSense. Composition: Cross-linked hyaluronic acid (HA): 25 mg/ml Lidocaine; 0,3%, (injection).

Injection of 0.1-0.2 ml per interdental papilla 3 times with 3-week interval.

干预措施: Teosyal PureSense Global Action HA Injection (Drug)

结局指标

主要结局

Black Triangle Area

时间窗: After the last injection: 1 month - 3 months

Using standardized intraoral photographs, change in black triangle area in mm² will be measured

Intedental Papilla Reconstruction Rate

时间窗: After the last injection: 1 month - 3 months

Changes in Black Triangle Area given in percentage to the baseline values

次要结局

  • Black Triangle Height(After the last injection: 1 month - 3 months)
  • Patient Satisfaction Score(After the last injection: 3 months)
  • Black Triangle Width(After the last injection: 1 month - 3 months)

研究者

发起方
Altinbas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Baris Impram

Principal Investigator

Altinbas University

研究点 (1)

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