Efficacy of Irimedadi oil and Virgin Coconut oil pulling on plaque induced gingivitis: a randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. The patients’ PI, GI and gingival bleeding scores will be recorded.
研究概览
简要总结
NEED FOR STUDY: Optimal oral hygiene is achieved by maintenance of a healthy periodontium along with caries free teeth. Presence of periodontal diseases such as gingivitis and periodontitis can be attributed to numerous factors, out of which the most common is plaque accumulation. This optimal oral health can be achieved by two methods, A) mechanical methods such as scaling, root planning, tooth brushing, flossing and tongue cleaning, and B) chemical methods such as use of mouthwashes and therapeutic dentifrices. [2,4] Along with these established dental aids, more research is done to incorporate other products, for example, a study on rats was conducted by Shern et al in which 0.1% stannous fluoride rinses for decreased plaque accumulation was demonstrated. These new improvements along with the currently used mouthwash considered as gold standard i.e., 2% Chlorhexidine have certain unpleasant side effects such as unpleasant taste, and their chemical nature could cause tooth staining. [5] Ayurveda, the ancient medical system developed in India is a reservoir of natural, palnt based remedies for all diseases and ailments of the human body. Herbal products prove to be useful as they work without alcohol incorporation, and thus produce less side effects. [5] Ayurveda provides good alternatives for dental and oral health management, which include procedures such as kavala, gandusha, dantadhavana, and jivha lekhana. [2] Out of these methods, kavala and gandusha styles are used under oil pulling, a method of swishing oil in the mouth, which is in use for 5000 years to maintaining good oral hygiene. [1] Oil pulling claims to be useful in decreasing the levels of toxins and bacterial load from the mucous membrane and the blood stream. However more scientific evidence which supports this claim is lacking. [6] Recent studies have reported decrease in the levels of Streptococcus mutans in plaque after oil pulling done with virgin coconut oil. [1] According to a systematic review conducted by Woolley et al more properly designed randomized controlled trials among different strata of the population are needed to assess the impact of coconut oil pulling on oral health. [6] Irimedadi oil is made of Yashti, Trijatha, Manjishta, Gayatri, Lodhra, Katphala, Kshirivrikshatwak, Irimeda twak, Musta, Agaru, Shvetachandana, Rakta chandana, Karpoora, Jati, Takkola, Mamsi, Dhataki, Gairika, Mrinala, Mishi, Vaidedi, Padmakesara, Kumkuma, Laksha, Samanga, Manjishta, Brihati, Bilvapatra, Suradruma, Shaileya, Sarala, Sprikka, Palasha, Rajani, Daruharidra, Priyangu, Tejani, Pradhakaleya, Pushkara, Jaya, Vyaghri, Madana, Tila taila***. [2] In Ayurveda, dental indications for the use of this oil are* stomatitis, glossitis, apthous ulcers, dental caries, pyorrhea, gingivitis, stains removal and hyperemia of gums. But the effect of Irimedadi taila on plaque reduction and plaque induced gingivitis has not been explored. [2] Thus, a comparison between these two oils used for oil pulling, with the purpose of determining their efficacy on the improvement of the oral health and decreasing the oral plaque inducing bacterial load as an alternative oral hygiene aid is the purpose of this study. AIM: To assess the efficacy of Irimedadi oil & virgin coconut oil pulling as an adjunct therapy on plaque induced gingivitis. OBJECTIVES: 1. To evaluate & compare the baseline and post intervention microbiological effect along with PI, GI and gingival bleeding scores among patients assigned Irimedadi oil. 2. To evaluate & compare the baseline and post intervention microbiological effect along with PI, GI and gingival bleeding scores among patients assigned Virgin Coconut oil. 3. To compare the microbiological effect along with PI, GI and gingival bleeding scores among the two interventions. METHODS: Invitation Patients from regular OPD will be invited to join the study. ENROLLMENT Patients selected as per inclusion criteria**.** BASELINE DATA COLLECTION 1. The patients’ PI, GI and gingival bleeding scores will be recorded. 2. Plaque samples will be collected. 3. Scaling and polishing will be done, to bring the plaque score down to 0. RANDOMISATION Block randomization sampling technique is used to form the test & control group. INTERVENTION Group A (test) will be given 100ml Irimedadi oil and Group B (control) will be given 100ml virgin coconut oil. They will be asked to perform oil pulling once daily after tooth brushing using modified BASS technique for 28 days FOLLOW UP Participants will be called in after every 10 days to assess the use of oil, and to provide them with more. 2nd DATA COLLECTION 1. Follow up will be done after 28 days, PI, GI and gingival bleeding scores will be recorded. 2. Plaque samples will be collected. MICROBIOLOGICAL TESTING 1. Collected plaque samples will be forwarded for microbiological lab testing for CFU as & when collected during pre & post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with minimum 20 teeth present.
- •Patients who have not received any periodontal therapy in past 6 months.
- •Patients with GI score ≥ 1
- •Patients with presence of bleeding on probing & probing depth ≤ 3mm
- •Patients willing to participate.
排除标准
- •Patients practicing oil pulling with other oils.
- •Patients on any antibiotic therapy.
- •Pregnant or lactating mothers.
- •Patients with tobacco habits.
- •Patients with periodontal pockets ≥ 4mm.
- •Patients with known history of allergy towards herbal products.
- •Patients who are mouth breathers.
- •Patients undergoing any orthodontic therapy.
结局指标
主要结局
1. The patients’ PI, GI and gingival bleeding scores will be recorded.
时间窗: Baseline
2.Plaque samples will be collected & CFUs will be calculated.
时间窗: Baseline
3.Scaling and polishing will be done, to bring the plaque score down to 0
时间窗: Baseline
次要结局
- 1.Follow up will be done after 28 days, PI, GI and gingival bleeding scores will be recorded.(2.Plaque samples will be collected & CFUs will be calculated.)
研究者
INAMDAR ISHA ABHAY
Dr. DY Patil Dental College and Hospital, Pimpri
