Adjunctive Treatment of Residual Periodontal Pockets Using a Hyaluronic Acid-based Gel: A 12-month Multicenter Randomized Triple Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 主要终点
- PD (change is being assessed)
研究概览
简要总结
Objective: To evaluate the adjunctive effect of hyaluronic acid (HA) gel in the treatment of residual periodontal pockets over a 12-month period.
Materials and Methods: Periodontal patients enrolled in maintenance and presenting at least one periodontal pocket 5-9 mm of depth in the anterior area were recruited from six university-based centers. Each patient was randomly assigned to control treatment with professional mechanical plaque removal (PMPR) and local placebo application or test treatment with the adjunctive use of HA to PMPR. Clinical parameters [i.e. probing depth (PD), bleeding on probing (BoP), plaque score, recession (REC), and clinical attachment loss (CAL)] and microbiological samples for the investigation of the total bacterial count (TBC) and presence of specific bacterial strains (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum) were taken at baseline and every 3 months, until study termination. PD was determined as the primary outcome variable.
详细描述
Population A total of 144 patients were enrolled from 6 university clinical centers (Sapienza University of Rome, Department of Periodontology, Rome, Italy ; University of Rijeka, School of Dental Medicine, Rijeka, Croatia; University of Zagreb, Department of Periodontology, Zagreb, Croatia; Jagiellonian University, Dental Institute, Krakow, Poland; Medical University of Sofia, Faculty of Dentistry, Sofia, Bulgaria; Medical University of Plovdiv, Faculty of Dentistry, Plovdiv, Bulgaria). The extension in time from patient recruitment to end of the protocol was January 2016 to November 2018.
The sample size was determined considering the patient level as statistical unit and probing depth (PD) as the primary outcome measure. In order to detect a mean difference of 1 mm of PD between groups with a standard deviation of 1 mm, maintaining a power of 85%, a significance level (alpha) of 0.05 and a drop-out of 25%, 12 participants per group in each center were required.
The ethical committees of each center approved the protocol of this study. The protocol followed the ethical principles of Helsinki Declaration on the good conduct of clinical trials. All patients were thoroughly informed on the treatment details and on the possibility of being excluded from the study if missing any of the 3 months follow-up appointments or showing poor compliance in general. After verbally accepting the conditions of the protocol, patients signed the informed consent prior to study initiation. Figure 1 shows step by step the study protocol that each patient followed.
Study design, randomization, allocation concealment and blinding This study was projected as a controlled randomized multicenter triple blinded 12-month clinical trial to compare the treatment of residual periodontal pockets using standard non-surgical mechanical debridement with and without hyaluronic acid gel. The detailed description of the treatment and evaluation is described in the following paragraphs.
The operators were trained and calibrated on treatment application and on PD measurement prior to study initiation. A preliminary session of PD measurements on 3 periodontal patients revealed an intra-class correlation coefficient ≥ 0.75 for each operator and among different operators.
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
- Double (Participant, Care Provider)
盲法说明
Clinical operators were kept blind until the moment of adjunctive treatment application allocated by the randomizer. Patients remained blinded during the entire follow-up. Microbiological evaluation and statistical interpretation of the results were made blinded on the treatment performed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 years of age
- •systemically healthy,
- •smoking less than 10 cigarettes/day
- •having been treated for periodontitis but with at least one single residual pocket of 5-9mm of depth located in the anterior area (incisors and canines)
- •full-mouth bleeding score (FMBS)
- •full-mouth plaque score (FMPS) less than 20%
- •showing a good compliance to oral hygiene instructions
排除标准
- •were pregnancy/lactation
- •use of antibiotics in the last 3 months for a period of two weeks or more
- •use of drugs causing gingival hyperplasia
- •use of corticosteroids or anti-inflammatory drugs for a period of two weeks or more
- •presence of diseases knowing to influence the wound healing/tissue response
- •thyroid or pituitary gland malfunction or abnormal hormonal levels
- •hyaluronic acid contraindications
- •subjects under anticoagulant treatment
- •use of systematic antibiotics for endocarditis prophylaxis
- •radiation therapy in head and neck area
- •use of bisphosphonate drugs prescribed for patients with osteoarthritis
- •tooth mobility.
研究组 & 干预措施
Hyaluronic acid
After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of hyaluronic acid gel . This adjunctive treatment was performed at baseline and at the 3 months control.
干预措施: Hyaluronic Acid (Drug)
Lidocaine
After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of anesthetic. This adjunctive treatment was performed at baseline and at the 3 months control.
干预措施: Lidocain (Drug)
结局指标
主要结局
PD (change is being assessed)
时间窗: at baseline and at 3, 6, 9, and 12 months after being treated
probing depth (PD) measured with periodontal probe in mm
次要结局
- Dental plaque(change is being assessed)(at baseline and at 3, 6, 9, and 12 months after being treated)
- BoP(change is being assessed)(at baseline and at 3, 6, 9, and 12 months after being treated)
- REC(change is being assessed)(at baseline and at 3, 6, 9, and 12 months after being treated)
研究者
Andrea Pilloni MD DDS MS
Associate professor of Periodontology
University of Roma La Sapienza