Minimally Invasive Treatment for Papillae Deficiencies in Esthetic Zone Using Hyaluronic Acid
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- the papillary recession reduction (pRecRed).
研究概览
简要总结
Hyaluronic acid (HA) has been used as a dermal filler in medicine for many years. It also has umpteen benefits in terms of aiding in rapid healing and resolution of inflammation. Thus in the present study, HA has been used at the test site to fill papillary recession defects. At the control site saline was injected as the placebo.
详细描述
INTRODUCTION Periodontal diseases, trauma, treatment of periodontal diseases and iatrogenic causes lead to papillary tissue loss in the interproximal area.1 Management of soft tissue deformities in the interproximal space can be advocated through several surgical and non-surgical techniques. The non-surgical approaches - orthodontic, prosthetic and restorative procedures modify the interproximal space, thereby altering the soft tissue morphology. The surgical techniques aim to recontour, preserve or reconstruct the soft tissue between teeth and implants. Surgical techniques, due to their invasive and unpredictable nature and limited blood supply/ minimal access makes regeneration of deficient papilla a highly sensitive procedure.2 Hyaluronic acid (HA) is a high molecular weight polysaccharide that plays a vital role in the functioning of extracellular matrices, including those of mineralized and non-mineralized periodontal tissues. HA helps in tissue hydrodynamics, cell migration/ proliferation, anti-inflammatory role and facilitates healing.3 HA has shown anti-inflammatory, anti-edematous and anti-bacterial effects in the treatment of gingivitis and periodontitis.4 Deviating from these utilities, HA also plays an important role in the non surgical facial rejuvenation through bioengineered hyaluronic acid derivatives. The exquisite role of bioengineered hyaluronic acid derivatives for soft tissue augmentation in gingival deficiencies has not been researched enough. Based on this beneficial effect of HA in dermatology, the present triple blind split mouth randomised clinical trial was planned to evaluate the injection of HA dermal filler as a minimally invasive treatment modality for the reconstruction of lost interdental papilla.
The aim of the present study was to evaluate the efficacy of hyaluronic acid dermal filler for interproximal papillary augmentation in Nordland's Class I and Class II5 interdental papillary recession defects.
MATERIALS AND METHODS:
PARTICIPANTS:
15 adult patients from the out-patient department of Department of Periodontology, Krishnadevaraya College of Dental Sciences, Bangalore, India, aged between 25-75 years were recruited among those seeking treatment for esthetics in the maxillary anterior region due to interdental papilla recession, from July 2013 to September 2014. The details of the study and the procedure were explained to the patients and an institutional review board approved informed consent was obtained from each patient, affiliated to Rajiv Gandhi University of Health Sciences (ACA/DCD/SYN/KCODS - B/PG/2012-2013) (02_D012_36683).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age group of 25-75 years, with at least one pair of similar bilateral, Nordland's class I and class II loss of interdental papillae in the maxillary anterior region, radiographic evidence of sufficient interdental alveolar bone (i.e. distance between alveolar crest and contact point ≤ 5mm), pocket probing depth ≤ 4mm, systemically healthy patients, patients willing to participate in the study and patients with esthetic concerns
排除标准
- •Patients with known allergy to hyaluronic acid, patients with poor plaque control.(≥20% O'Leary plaque index), medically compromised patients, pregnant and lactating women, history of smoking, who had received a crown or pontic on one or both teeth involved in the interproximal space, interproximal spaces next to teeth that included root grooves, furcations, Miller's tooth mobility index >18, open contacts, probing depths >3 mm, and radiographic evidence of pathology, with translocated or tilted teeth, and who had undergone papillary regeneration procedures in the area selected previously
结局指标
主要结局
the papillary recession reduction (pRecRed).
时间窗: 6 month
. papillary recession depth (distance from the contact point to gingival margin was measured to the nearest millimeter- CP -GM)
percentage papillary coverage(PPC
时间窗: 6 month
The formula used to calculate the percentage papillary coverage was as follows- Baseline (CP-GM) - 6 month (CP-GM) ---------------------------------------------- x 100 Baseline (CP-GM)
次要结局
未报告次要终点