A Comparison of Three Different Modalities in Improving Oral Hygiene in Adult Orthodontic Patients - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Gingival Index (GI)
研究概览
简要总结
The objective of the study is to compare effectiveness of OHI modalities a. verbal vs videographic material, b. Verbal vs plaque disclosing tablet and c. Videographic material vs plaque disclosing tablet over 3 months in adult orthodontic patients undergoing Fixed Appliance Treatment (FAT). Secondary objective of this study is to evaluate influence of three different modalities on patient cooperation and compliance towards orthodontic treatment.
详细描述
It has been demonstrated that a rapid decline in oral hygiene compliance occurs after the initial bonding of fixed appliances, as orthodontic brackets favor plaque accumulation by hindering routine oral hygiene procedures such as tooth brushing and flossing. Tooth brush access to the buccal surfaces of teeth becomes problematic and predisposes plaque buildup around brackets. Inefficient removal of supra-gingival plaque leads to the development of gingival inflammation and hyperplasia.
SAMPLE SIZE:
Sample size is calculated in OpenEpi (version 3.01) sample size calculator using findings of westmead who reported mean change in verbal group for BI as 0.93 ± 0.07 (Pre-instructions = 2.31 ± 0.50 and Post-instructions = 3.24 ± 0.43) and mean change in plaque disclosing tablet group for BI as 2.9±0.21 (Pre-instruction = 4.30 ± 0.46 and Post-instruction = 1.39 ± 0.25) keeping the power of test as 90% and confidence interval of 95%, the calculated sample size came out as 1 in each group. Richter et al who reported mean compliance in low adherent group of 62.2 ± 32.3 in initial leveling and alignment of orthodontic treatment and 81.4 ± 15.5 in molar correction or space closure stage. Keeping α = 0.05 and a power of 80% sample size was calculate to be 33. Therefore we will take 33 subjects in each group.
RANDOMIZATION : Permuted block Randomization with blocks of 6 will be utilized to ensure equal representation of all 3 arms in each block. The eligible subjects in each group will be randomized to one of three groups at a 1:1:1 allocation ratio. Randomization will aid in minimizing selection bias.
ALLOCATION CONCEALMENT MECHANISM Sealed opaque envelopes containing random group information will be used in this trial, thus preventing tampering and reading of the assigned group before the subject number is given. The sealed opaque envelops will be produced by the CTU department using a system that automates the random assignment of treatment arms to subject numbers with a 1:1:1 allocation ratio within each age group. Designated CTU personnel will be responsible to the production of the randomization list and the sealed envelopes. Study staff will collect the envelopes from CTU pharmacist prior to randomization. They must be stored in a secure place and opened one by one, only after the subject has been found eligible to be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing orthodontic treatment with fixed appliance (FAT) since 6 months
- •Patients of both gender, aged 18-36 years. As, chances of declining periodontal status increases after 36 years of age.
- •Patients having an Andriod phone with Whatsapp application installed..
- •Patients with all bonded teeth mesial to the first molars.
- •Healthy patients with no co-morbids such as rheumatic fever, blood dyscrasias, congenital heart disease or diabetes mellitus.
- •Subjects with gingivitis as assessed by bleeding index (score ≤1), orthodontic plaque index (score ≤2) and gingival index (score ≤1) as assessed by Williams -Probe.
- •All patients who will give consent for participation.
排除标准
- •Subjects with clinical attachment loss of greater than 2 mm on two sites.
- •Pregnant or lactating females.
- •Subjects with removable/fixed dental prosthesis or banded teeth.
- •History of surgical or nonsurgical periodontal therapy in the last 6 months.
- •Current smokers or smokeless tobacco users. (According to glossary of Centers for Disease Control and Prevention, an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes is considered to be current smoker).
- •Patients having systemic reasons for periodontal diseases for example uncontrolled diabetes, hypertension.
研究组 & 干预措施
video group
Group A: A 3 minute video will be shown providing information regarding the care of the dentition during Fixed Appliance Treatment along with the importance of patient compliance and cooperation. The video will also be showing the consequences of poorly followed instructions such as gingivitis and white spot lesions. Participants in this group will also receive the same video graphic educational material through their Whats app once weekly for a total duration of 3 months.
干预措施: Video on oral hygeine instructions (Other)
Plaque disclosing tablet
Group B: Plaque-disclosing tablets will be taken by patients on chair-side showing the location of the biofilm. The patients will be given plaque disclosing tablets to be used once weekly for 3 months to evaluate their oral hygiene at home. They will be given written information in the form of leaflets on importance of cooperation and compliance. Participants in this group will receive a reminder log fill, and tablets that are not used will be asked to return to the investigator by the participants to check the compliance.
干预措施: Plaque disclosing tablets (Drug)
结局指标
主要结局
Gingival Index (GI)
时间窗: 10 months
0.No inflammation 1. Mild inflammation: slight change in color, slight edema, no bleeding on probing 2. Moderate inflammation: moderate glazing, redness, bleeding on probing 3. Severe inflammation: marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding
Bleeding Index (BI):
时间窗: 10 months
0.Absence of bleeding after 30 seconds 1. Bleeding observed after 30 seconds 2. Immediate bleeding
Orthodontic Plaque Index (OPI)
时间窗: 10 months
0.No plaque deposits on the tooth surface surrounding the bracket base 1. Plaque deposits on one tooth surface at the bracket base 2. Plaque deposits on two tooth surfaces at the bracket base 3. Plaque deposits on three tooth surfaces at the bracket base 4. Plaque deposits on four tooth surfaces at the bracket base and/or gingival inflammation indicators (plaque deposits near the gingiva do not necessarily have to be present)
次要结局
- Orthodontic Patient Cooperation Scale (OPCS)(11 months)
- Clinical compliance evaluation form (CCE)(11)
研究者
Dr. Umair Shoukat
Co-investigator
Aga Khan University