The Additional Effect of Including Tongue Scraping to the Oral Hygiene Instructions on Halitosis Parameters in Periodontitis Patients Undergoing Standard Initial Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Improving of halitosis parameters (organoleptic scores)
研究概览
简要总结
Periodontitis can lead to tooth loss which may impair chewing ability and aesthetics. In addition, periodontitis can give rise to halitosis.
Standard initial periodontal treatment consists of supra and subgingival biofilm reduction and removal of calculus. Recently, the European Federation of Periodontology introduced clinical practice guidelines for the treatment of periodontitis. The use of a tongue scraper is not mentioned as element in the standard initial treatment of periodontitis.
The investigators have planned a clinical study in order to provide information about the effect of standard initial periodontal therapy and the additional effect of the use of a tongue scraper as part of the oral hygiene instructions on halitosis parameters in periodontitis patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Males or females American Society of Anesthesiologist classification I of II,
- •18 years of age or older,
- •In good general health as documented by self-assessment
- •Suffer from generalised periodontitis (according to 2018 classification)
- •Suffer from halitosis with suspected intra-oral cause: organoleptic score (OLS) of 2 or higher by an experienced oral malodour judge
- •At least one volatile sulphur compounds(VSCs) measurement above the following thresholds:
- •Portable sulphur detector (Halimeter) > 107 ppb
- •Oral Chroma™: hydrogen sulfide (H₂S) > 112ppb
- •Oral Chroma™: methyl mercaptan (CH3SH) >28ppb
排除标准
- •Participant has a history of chemotherapy or radiotherapy in head and neck area
- •Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- •Female who is pregnant, breast-feeding or has the intention of becoming pregnant in the following 6 months
- •Participation in another interventional Trial with an investigational medicinal product (IMP) or device
- •Recent intake of antibiotics (3 months prior to the first consultation)
- •Antibiotics indicated as part of the periodontal treatment
- •Use of antibiotics during the course of the study
- •Suffer from halitosis with suspected extra-oral cause
- •Suffer from a systemic disease that could cause extra-oral halitosis (e.g. diabetes mellitus, liver or kidney failure, trimethylaminuria)
- •Participant has a history of rheumatic fever, neurological deficiencies, or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal anti-inflammatory drugs)
- •Presence of active caries lesions
- •Unwillingness to return for the follow-up examination
- •Wear partial prosthetic dentures removables
- •Participant has less than 20 teeth
研究组 & 干预措施
Test 1 - tongue scraping full length of study
Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper
干预措施: tongue scraper (Other)
Control- No tongue scraping full length of study
Oral hygiene instructions before and after non-surgical treatment without inclusion of tongue scraper
Test 2 - tongue scraping only after non-surgical therapy
Oral hygiene instructions before and after non-surgical treatment with inclusion of tongue scraper only after treatment
干预措施: tongue scraper (Other)
结局指标
主要结局
Improving of halitosis parameters (organoleptic scores)
时间窗: 18 weeks
Reduction in organoleptic scores measured in a six point intensity scale proposed by Rosenberg and colleagues. The different scores of this scale are defined as : * 0: no odour (below the smell threshold) * 1: barely noticeable odour * 2: slight odour * 3: moderate odour * 4: strong odour * 5: extremely strong odour, close to saturation
次要结局
- improving of periodontal parameters(18 weeks)
- improving of oral hygiene parameters.(18 weeks)
- Improving of volatile sulphur compounds (VSCs)(18 weeks)
研究者
Ana CASTRO SARDA
Dr
Universitaire Ziekenhuizen KU Leuven