3D VOLUMETRIC CHANGE OF THE PALATAL DONOR REGION IN WOUND HEALING
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Examination of volume change in the palatal donor region in smoking and non-smoking patients
研究概览
简要总结
The purpose of this clinical trial is planned to be conducted with 45 individuals aged between 18-65, with Cairo type I gingival recession and patients requiring free gingival surgery. It was aimed to investigate when the palatal mucosa will return to its previous volume in the donor area and the effect of smoking. The main questions it aims to answer are:
- Evaluation of 3D volume change of the palatal donor area from which free gingival graft was taken
- determining how long it takes for the palatal mucosa to regain its original shape and thickness Participants will be asked to comply with postoperative recommendations and pay attention to oral hygiene.
If there is a comparison group: Researchers use it to see if smoking affects the volume change in the donor area.
They will compare non-smokers with clinically healthy gums, 'light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums, and ex-smokers with clinically healthy gums who have not smoked for 5 years.
详细描述
This study is planned to be conducted with 45 individuals aged between 18-65 who applied to Necmettin Erbakan University Faculty of Dentistry Department of Periodontology for various reasons. In the Department of Periodontology, each patient diagnosed with periodontal disease after clinical and radiological evaluation is initially treated with phase-1 treatment. In addition, the treatment of patients with mucogingival problems (gingival recession, keratinized gingival insufficiency, shallow vestibule depth) whose phase-1 treatment has been completed in our periodontology clinic continues (with free gingival graft and connective tissue graft surgery, etc.). Pre- and post-operative clinical measurements and photographs of patients for whom surgical procedures are planned are taken and kept in our archive.
In this prospectively planned study, the palatal area of patients who have received an indication for free gingival surgery for any reason and who meet the inclusion criteria and have agreed to participate in the study will be scanned with an intraoral scanner before and after the procedure, and the changes in palate volume will be monitored at 1st and 3rd month follow-ups.
Inclusion and exclusion criteria (limitations):
Study inclusion criteria:
- Volunteers aged 18 and over
- Patients with Cairo type I gingival recession and requiring free gingival surgery
- Not having a psychiatric, mental or physical disability
- Not having received periodontal treatment in the last 6 months
- Being systemically healthy
- Having at least 20 teeth in your entire mouth
- Getting diagnosed with healthy gums
- Not using any medication
- Not being pregnant
- Not having used any antibiotics, anti-inflammatory or any other drugs that may affect periodontal tissues in the last 6 months for any reason.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers aged 18 and over
- •Treatments with Cairo type I gingival treatment and requiring free gingival surgery
- •There is no psychiatric, mental or physical disability
- •My son has not received periodontal treatment within 6 months.
- •Being systemically healthy
- •Having at least 20 teeth in your entire mouth
- •Getting diagnosed with healthy gums
- •Not using any medication
- •Not pregnant
- •Not having used any antibiotics, anti-inflammatory or any other medication that will swell the periodontal tissues in the last 6 months for any reason.
排除标准
- •Being outside the inclusion criteria and not agreeing to participate in the study
结局指标
主要结局
Examination of volume change in the palatal donor region in smoking and non-smoking patients
时间窗: 3 months
It was aimed to examine the volume change among the 3 groups in our study by looking at its connection with smoking. A study plan was created by comparing the 3D shape device on which the scans were made with Geomatic Control X and looking at the volume change.
次要结局
未报告次要终点
研究者
FATMA SARAÇ
research assistant
Necmettin Erbakan University