跳至主要内容
临床试验/NCT07450573
NCT07450573已完成不适用

Impact of Periodontal Therapy on Function and Quality of Life in Stage III Periodontitis

Ankara Medipol University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Plaque index

研究概览

简要总结

Stage III, Grade B periodontitis is a severe form of gum disease that damages the tissues and bone supporting the teeth. It can cause loose teeth, difficulty chewing, and reduced quality of life. Although periodontal (gum) treatment is known to improve gum health, less is known about how it affects chewing ability and how patients feel about their oral health after treatment.

This study looked at how comprehensive periodontal treatment affects gum health, chewing function, and oral health-related quality of life. Twenty patients with Stage III, Grade B periodontitis and twenty individuals with healthy gums participated. Patients with periodontitis received non-surgical treatment (deep cleaning and root surface debridement) followed, when needed, by surgical periodontal therapy.

Researchers measured gum health (including probing depth and bleeding), tooth mobility, chewing performance, and patient-reported quality of life. Chewing performance was tested using a standardized chewing test with silicone material. Quality of life was assessed using a validated questionnaire (OHIP-14), which measures how oral health affects daily life, comfort, and well-being.

Assessments were performed before treatment, after non-surgical therapy, and after surgical treatment.

At the start of the study, patients with periodontitis had worse gum health, poorer chewing ability, and lower oral health-related quality of life compared to healthy individuals. After treatment, gum inflammation and tooth mobility significantly improved. Chewing ability also improved after therapy, especially after surgical treatment. Patients reported better quality of life, with fewer symptoms and less discomfort.

The study also found that better chewing performance was strongly associated with better quality of life. This suggests that improving function is closely linked to how patients feel about their oral health.

Overall, comprehensive periodontal therapy not only improves clinical gum health but also enhances chewing efficiency and patient well-being. These findings highlight the functional and quality-of-life benefits of periodontal rehabilitation in patients with advanced gum disease.

详细描述

Stage III, Grade B periodontitis is characterized by advanced periodontal attachment loss, deep periodontal pockets, tooth mobility, and radiographic bone loss. In addition to structural damage, this condition may impair masticatory efficiency and negatively affect oral health-related quality of life (OHRQoL). While conventional periodontal therapy effectively reduces inflammation and stabilizes periodontal tissues, its functional and patient-reported outcomes in advanced disease stages require further clarification.

This prospective controlled clinical study was designed to evaluate the impact of comprehensive periodontal therapy on clinical periodontal parameters, objective masticatory performance, and OHRQoL in patients with Stage III, Grade B periodontitis.

Study Population: The study included 20 systemically healthy patients diagnosed with Stage III, Grade B periodontitis and 20 periodontally healthy individuals serving as controls. Participants were recruited from a university dental clinic. Inclusion criteria for the periodontitis group were consistent with current periodontal classification guidelines. Exclusion criteria included systemic diseases affecting periodontal status, recent periodontal treatment, smoking, pregnancy, and use of medications known to influence periodontal tissues.

Study Design and Interventions: At baseline, all participants underwent comprehensive periodontal examination, including; Probing depth (PD), Bleeding on probing (BOP), Clinical attachment level (CAL), Tooth mobility measured using Periotest. Masticatory performance was assessed using a standardized silicone cube chewing test. Participants chewed the test material for a defined number of cycles. The comminuted material was sieved through multiple apertures to calculate objective performance indices. OHRQoL was evaluated using the validated Oral Health Impact Profile (OHIP-14) questionnaire.

Patients in the periodontitis group received: Non-surgical periodontal therapy (scaling and root planing) and surgical periodontal therapy when indicated, following re-evaluation. Clinical and functional assessments were repeated after completion of non-surgical therapy and again following surgical treatment. The healthy control group was evaluated once for baseline comparison.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
31 Years 至 51 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Eligibility criteria included
  • ≥ 20 natural teeth
  • at least four functional chewing units (one molar pair = two units; one premolar pair = one unit).
  • positive bleeding on probing in ≥ four chewing units
  • probing depth ≥ 5 mm in ≥ four molar or premolar teeth
  • age between 20 and 45 years.

排除标准

  • Individuals with systemic diseases
  • pregnancy
  • smoking habits
  • recent antibiotic or anti-inflammatory use

研究组 & 干预措施

Periodontal teratment

Active Comparator

Periodontitis patients underwent both non-surgical and surgical periodontal treatments.

干预措施: non-surgical periodontal treatment (Procedure)

Periodontal teratment

Active Comparator

Periodontitis patients underwent both non-surgical and surgical periodontal treatments.

干预措施: surgical periodontal treatment (Procedure)

Periodontal evaluation

No Intervention

Both Healthy controls and periodontitis patients went through periodontal examination.

结局指标

主要结局

Plaque index

时间窗: At Day 0, Day 30, Day 90

Plaque accumulation was assessed using a standardized plaque index at four sites per tooth. The presence of visible dental plaque along the gingival margin was recorded following gentle probing and air-drying when necessary. Scores were assigned according to established criteria (0 = no plaque; 1 = plaque detectable with probe; 2 = visible plaque; 3 = abundant plaque accumulation). Mean plaque index scores were calculated per participant to reflect overall oral hygiene status. Higher scores indicate greater plaque accumulation and poorer oral hygiene.

Probing depth

时间窗: At Day 0, Day 30, Day 90

Probing depth was measured in millimeters using a calibrated periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual/palatal, midlingual/palatal, distolingual/palatal). The distance from the gingival margin to the base of the periodontal pocket was recorded. Measurements were rounded to the nearest millimeter. Mean probing depth values were calculated per participant. Greater probing depth values indicate more severe periodontal tissue destruction and disease severity.

Clinical attachment level

时间窗: At Day 0, Day 30, Day 90

Clinical attachment level was measured in millimeters using a calibrated periodontal probe at six sites per tooth. CAL was calculated as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. In cases of gingival recession, the recession value was added to the probing depth; in cases of gingival enlargement, it was subtracted accordingly. Mean CAL values were calculated per participant. Higher CAL values indicate greater loss of periodontal attachment and increased disease severity.

Bleeding on probing

时间窗: At Day 0, Day 30, Day 90

Bleeding on probing was assessed at six sites per tooth using a calibrated periodontal probe. After gentle probing of the sulcus or periodontal pocket, the presence or absence of bleeding within 15 seconds was recorded. BOP was expressed as the percentage of bleeding sites relative to the total number of sites examined per participant. Higher percentages indicate increased gingival inflammation and active periodontal disease.

Tooth mobility measurement

时间窗: At Day 0, Day 30, Day 90

Tooth mobility was quantified using a Periotest M device (Medizintechnik Gulden, Modautal, Germany). Periotest values (PTVs) between +10 and +30 indicated Miller Class II, and between +30 and +50 Miller Class III mobility.

Masticatory performance

时间窗: At Day 0, Day 30, Day 90

Masticatory efficiency was assessed using the silicone cube chewing test. Standardized cubes(8 × 8 × 8 mm) were prepared from Optosil® (Heraeus Kulzer, South Bend, IN, USA) using a plexiglass mold, sterilized in an autoclave, and weighed for standardization. Participants were instructed to chew eight cubes for 20 cycles while seated upright. The procedure was visually monitored by the examiner and recorded on video to verify the number of cycles. The chewed material was collected, rinsed, and dried at room temperature for three days before analysis. Chewed samples were analyzed using a multiple-sieve system with apertures of 4.0, 2.0, 1.0, 0.5, and 0.25 mm (in accordance with the ISO standard). The participant rinsed their mouth with water to remove residual particles, expelling them into the same receptacles. The particles were washed with water, allowed to dry, and removed from the paper filter. The median particle size was calculated from the cumulative weight distribution.

次要结局

  • Assessment of oral health-related quality of life(At Day 0, Day 30, Day 90)

研究者

发起方
Ankara Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeliha Guney

Clinical Professor

Ankara Medipol University

研究点 (1)

Loading locations...

相似试验