Effects of Periodontal Disease Prediction System on Oral Hygiene Motivation in Patients With Periodontitis: A Prospective Randomised Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- rustogi modified navy plaque index (RMNPI)
研究概览
简要总结
The aim of this trial is to evaluate the effect of patient specific periodontal disease prediction (PDP) system, a part of motivational interview, (MI) on probing depth (PD), Rustogi modified Navy Plaque Index (RMNPI), and papillary bleeding index (PBI) scores in patients with periodontitis following non-surgical periodontal therapy.
详细描述
A total of 120 participants included in our study and were then randomly assigned to three groups: a) conventional method (CM) (n=40), b) three-dimensional animation (3DA) (n=40), and c) Periodontal Disease Prediction (PDP) interaction (n=40). PD, PBI, and RMNPI values were recorded before periodontal therapy (T0). Following periodontal treatment, individuals in the CM group were instructed on oral hygiene via a model and brochure. Individuals in the 3DA group were informed using 3D video visuals. Participants in the PDP group were informed in a computer-based three-dimensional manner, providing projections of their current status and potential future gingival recessions after viewing the first and second parts of the 3D animation. Clinical periodontal measurements were repeated at 3, 6, and 12 months post-treatment. Data obtained after the study were analyzed using appropriate statistical methods. It was concluded that the proposed approach in this project could enhance periodontitis individuals' awareness about periodontal disease and personal oral hygiene especially for interdental cleaning over a long period. By this way, this PDP system can lead clinical benefits in reducing the recurrence of periodontal disease. It was hypothesized that patients in the PDP group could achieve significantly better plaque control and have lower bleeding scores compared to patients in the control groups, which include traditional oral hygiene motivation and three-dimensional video education.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 30 to 60 years.
- •No prior periodontal treatment or oral hygiene education.
- •Simplified Oral Hygiene Index (OHI-S) greater than 3 (indicating poor oral hygiene).
- •Diagnosed with 'Stage III' 'Grade B' periodontitis.
- •At least 20 natural teeth present (excluding third molars).
- •Minimum of 12 years of education.
- •Not a dentist or dental student.
- •No systemic diseases affecting memory or cognitive function.
- •No physical disabilities that could hinder the performance of oral hygiene procedures.
排除标准
- •Presence of diffuse dentinal hypersensitivity.
- •Acute infections.
- •Faulty restorations.
- •Root caries complicating oral hygiene.
- •Full-mouth fixed or removable dentures.
- •Ongoing orthodontic treatment.
研究组 & 干预措施
Conventional Method (CM)
Individuals in this group receive instructions on oral care after initial periodontal treatment from the physician (SG) who is familiar with the patient groups. The physician verbally explains the development of periodontal disease, its causes, symptoms, and the potential consequences of irregular oral care, using a brochure to reinforce these points.
干预措施: scaling root planing (Procedure)
Three-Dimensional Animation (3DA)
The video used in the study was created by DentalMaster (MD Stimulation Ltd) by combining their own footage (http://www.mdsimulation.com/). This video is divided into three parts, summarized below:
- i. Overview of the causes and symptoms of periodontal disease (section 1)
- ii. Treatment of periodontal disease and daily oral care practices for individuals (section 2)
- iii.Consequences of periodontal disease (such as gingival recession and tooth loss) that individuals may face if periodontal diseases are not treated and if they do not perform regular oral care (section 3). In this group, patients watch the video together with the physician (SG), who is familiar with the randomized patient groups.
干预措施: scaling root planing (Procedure)
Three-Dimensional Animation (3DA)
The video used in the study was created by DentalMaster (MD Stimulation Ltd) by combining their own footage (http://www.mdsimulation.com/). This video is divided into three parts, summarized below:
- i. Overview of the causes and symptoms of periodontal disease (section 1)
- ii. Treatment of periodontal disease and daily oral care practices for individuals (section 2)
- iii.Consequences of periodontal disease (such as gingival recession and tooth loss) that individuals may face if periodontal diseases are not treated and if they do not perform regular oral care (section 3). In this group, patients watch the video together with the physician (SG), who is familiar with the randomized patient groups.
干预措施: Three-Dimensional Animation (video1-2) (Behavioral)
Three-Dimensional Animation (3DA)
The video used in the study was created by DentalMaster (MD Stimulation Ltd) by combining their own footage (http://www.mdsimulation.com/). This video is divided into three parts, summarized below:
- i. Overview of the causes and symptoms of periodontal disease (section 1)
- ii. Treatment of periodontal disease and daily oral care practices for individuals (section 2)
- iii.Consequences of periodontal disease (such as gingival recession and tooth loss) that individuals may face if periodontal diseases are not treated and if they do not perform regular oral care (section 3). In this group, patients watch the video together with the physician (SG), who is familiar with the randomized patient groups.
干预措施: Three-Dimensional Animation (video 3) (Behavioral)
Periodontal Disease Prediction (PDP)
The patients in the test group viewed sections 1 and 2 videos in the same manner as the 3DA group. However, unlike the 3DA group, they did not view section 3. Instead, they were shown estimates of their current condition and potential future periodontal tissue loss (gingival recession) for 1-5 years, 5-10 years, and 10-20 years (1). These projections were presented to the patients in three dimensions with PDP visualisation.
干预措施: scaling root planing (Procedure)
Periodontal Disease Prediction (PDP)
The patients in the test group viewed sections 1 and 2 videos in the same manner as the 3DA group. However, unlike the 3DA group, they did not view section 3. Instead, they were shown estimates of their current condition and potential future periodontal tissue loss (gingival recession) for 1-5 years, 5-10 years, and 10-20 years (1). These projections were presented to the patients in three dimensions with PDP visualisation.
干预措施: Three-Dimensional Animation (video1-2) (Behavioral)
Periodontal Disease Prediction (PDP)
The patients in the test group viewed sections 1 and 2 videos in the same manner as the 3DA group. However, unlike the 3DA group, they did not view section 3. Instead, they were shown estimates of their current condition and potential future periodontal tissue loss (gingival recession) for 1-5 years, 5-10 years, and 10-20 years (1). These projections were presented to the patients in three dimensions with PDP visualisation.
干预措施: Periodontal Disease Prediction (PDP) (Behavioral)
结局指标
主要结局
rustogi modified navy plaque index (RMNPI)
时间窗: baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months
RMNPI was assessed using a specialized plaque staining agent on each of the nine sites on both buccal and lingual tooth surfaces. The individual mean PI was calculated by scoring the presence of plaque at each site as '1' and its absence as '0', then dividing by the total number of surfaces evaluated. Using this index, PI can be separately calculated for the entire mouth (A-I), the gingival margin (A-C), interproximal areas (D and F), and surfaces that come into contact with dental floss (A, C, D, and F)
次要结局
- papillary bleeding index (PBI)(baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months)
- Probing depth (PD)(baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months)
- bleeding on probing (BoP)(baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months)
- Gingival ındex (GI)(baseline (T0) and repeated at 3rd (T1), 6th (T2) and 12th (T3) months)
研究者
Şadiye GÜNPINAR
principal ınvestigator
Bezmialem Vakif University