Efficacy of a Zinc-L-Carnosine -Based Mouth Rinse on Periodontal Tissues and Pain After Scaling and Root Planing - a Randomized Clinical Trial; a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in Healing Index (H.I.)
研究概览
简要总结
A clinical trial to assess the effect of a Zinc-L-Carnosine-based mouth rinse on periodontal tissues and pain after scaling and root planing
详细描述
A randomized, double blind, 3 group parallel study with random allocation of 75 patients to any of three groups; Zinc-L-Carnosine-based mouth rinse, Chlorhexidine mouth rinse and placebo (water) control. Three days after professional oral hygiene, which aimed at the normalization of the periodontal index, the primary (HI, VAS) and secondary (mSBI; FMPS; VMI; SI) outcomes of the study are measured to obtain baseline information, and then scaling and root planing are carried out.
The participants will be advised to follow their regular oral hygiene procedures (tooth brushing) in addition to the allocated mouth rinse. They will be examined again for primary and secondary outcomes at 7 and 21 days.
Clinical evaluation:
Clinical examination of each participant will be done by a single examiner using the previously described VAS scale and a UNC periodontal probe (No. 5 explorer Hu-Friedy, Chicago, Ill). In addition to these indices, each subject will be asked to report any adverse events they have encountered during the experiment.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a PSR score greater than 2 that undergo a session of scaling and root planing
排除标准
- •Use of mouth rinses or local or general medication in the preceding three weeks
- •Any condition related with allergy or sensitivity with the mouth rinses ingredients
- •Systemic and chronic diseases in progress
研究组 & 干预措施
Zinc L-Carnosine mouth rinse
Using undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 60 seconds, 3 times daily
干预措施: Zinc L-Carnosine (Drug)
Chlorhexidine
Using undiluted 10 ml of Chlorhexidine mouth rinse, retain for 60 seconds, 3 times daily
干预措施: Chlorhexidine (Drug)
Water
Mouth rinsing with 10 ml of water, retain for 60 seconds, 3 times daily
干预措施: Water (Other)
结局指标
主要结局
Change in Healing Index (H.I.)
时间窗: 0, 7, 21 days
The Laundry-Turnbull and Howley index will be used to evaluate healing, considering the changes made by Pippi et al. In 2015. In particular, seven parameters will be assessed, to each of which a value of 1 or 0 will be assigned. The sum of the values will indicate the degree of healing to be compared between the different groups. These seven parameters are: redness of mucosa, granulation tissue, suppuration, swelling, re-epithelialization, bleeding, pain on palpation. Higher score means worse outcome.
Change in the Visual Analogue Scale (VAS) of pain
时间窗: 0, 7, 21 days
Participants will be asked to mark the perceived degree of pain on a scale of 100 dashes, with the lowest score being "no pain" and the highest "the worst pain". Higher score means worse outcome.
次要结局
- Change in Modified Sulcus Bleeding index (Mombelli) (mSBI)(0, 7, 21 days)
- Change in Full Mouth Plaque Score (O'Leary) (FMPS)(0, 7, 21 days)
- Change in Calculus index (Volpe-Manhold index) (VMI)(0, 7, 21 days)
- Change in Stain index (Macpherson stain index) (S.I.)(0, 7, 21 days)
研究者
Chiara Occhipinti
Professor
University of Milan