Comparison of Conventional and Modified Free Gingival Graft Techniques in Treating Mandibular Incisor Gingival Recession: a Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- measurement of preoperative periodontal parameters
研究概览
简要总结
The aim of this clinical study is to understand whether the modified free gingival graft technique is superior to the conventional free gingival graft:
Will gingival recession completely close in modified free gingival grafting areas? Will there be a significant increase in the amount of keratinized gingiva in modified free gingival grafting participants compared to traditional free gingival grafting participants? Participants will visit our clinic in the 1st, 3rd and 6th months. Necessary clinical parameter measurements will be made by the clinician.
详细描述
This study will include individuals who come to Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology for various reasons and agree to participate in the study (those who sign the 'informed consent form'). Radiographic and clinical evaluations are routinely performed during the periodontal examination of each patient applying to the periodontology clinic, and routine periodontal status records are taken and archived before and after each planned treatment.
The study was designed as a randomised controlled clinical trial in which 30 patients underwent free gingival grafting (FGG) operation and 30 patients underwent modified free gingival grafting operation (mod-FG). Clinical parameters of the patients were planned to be measured 1 week before, 1 month, 3 months and 6 months after the operation.
The following clinical measurements will be taken by a single investigator at baseline (1 week before surgery) and at 1, 3, 6 and 12 months after surgery:
- Gingival Recession Depth: The distance from the enamel-cementum border to the gingival margin will be measured with an accuracy of 0.1 mm.
- Recession width: The horizontal distance from the widest part of the recession at the enamel-cementum junction to the mesial and distal starting borders, measured with an accuracy of 0.1 mm.
- Keratised Tissue Height: The distance from the gingival margin to the mucogingival junction will be measured with an accuracy of 0.1 mm.
- Papil width: The length of the horizontal line connecting the zenith points of two neighbouring teeth, measured with an accuracy of 0.1 mm.
- Papil height: The length of the vertical distance from the papillary apex to the line passing through the zenith points of the teeth, measured with an accuracy of 0.1 mm.
- Tissue thickness: It will be measured 2 mm apical to the gingival margin in the mid-buccal region under topical anaesthesia with a root canal instrument fitted with a rubber stopper and the distance between the tip of the root canal instrument and the rubber stopper will be measured with a digital caliper.
- Pocket Depth: The distance between the base of the pocket and the free gingival margin will be measured with the help of a periodontal Williams probe at six points for each tooth and the pocket depth will be recorded.
After the initial examination, each person will be given individual oral hygiene instructions and will receive professional dental cleaning, root planing and polishing with a low abrasive polishing paste and a rubber band. Surgical treatment will be planned after adequate personal plaque control has been achieved.
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
- Single (Outcomes Assessor)
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 between 18-65 years.
- •To be systemically healthy.
- •Not smoking.
- •Individuals aged 18 years and over.
- •Shallow vestibule (≤5 mm).
- •The periodontal pocket depth of the tooth/teeth to be treated should be ≤3 mm and the degree of tooth mobility should be ≤
- •There should be no cervical composite restoration and no caries-free lesions on the teeth to be treated.
- •Presence of Cairo Type 1 class gingival recession on the buccal surface of at most 2 of the mandibular incisors.
排除标准
- •pregnancy
- •untreated periodontal disease
- •parafunctional habits
- •poor oral hygiene (persistent whole mouth plaque index > 20%)
- •iodine allergy
- •excessive dental crowding or misalignment of teeth.
研究组 & 干预措施
modified free gingival graft
A connective tissue pedicle flap will be applied before a free gingival graft is placed in the recipient area.
干预措施: Mod-fgg (Procedure)
traditional free gingival graft
干预措施: Fgg (Procedure)
结局指标
主要结局
measurement of preoperative periodontal parameters
时间窗: Preoperatively, before the start of treatment.
To determine the baseline condition, preoperative measurement of periodontal parameters (amount of keratinized tissue, papilla height, papilla width, probing pocket depth, amount of recession, tissue thickness) will be recorded in millimeters using a periodontal probe.
Preoperative Intraoral Photographs Capture and Evaluation
时间窗: Preoperatively, before the start of treatment.
Intraoral photographs of patients will be taken before surgery. These photographs will be used to meet the situation before and after treatment. The photographs will be taken with a high-performance digital camera under standardized angles and lighting. Unit of Measurement: General condition of oral structures (% change rate).
gingival index measurement
时间窗: Preoperatively, before the start of treatment.
The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding). Unit of Measurement: 0-3 scale.
Plaque Index (PI) measurement
时间窗: Preoperatively, before the start of treatment.
The degree of plaque accumulation on the tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The assessment will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This measurement will be used to objectively determine the degree of plaque formation.Unit of Measurement: 0-3 scale.
次要结局
- Measurement of Periodontal Parameters(1,3 and 6 months post-operation.)
- Post-Operative Photographing and Evaluation(1,3 and 6 months post-operation.)
- gingival index measurement(1,3 and 6 months post-operation.)
- Plaque Index (PI) measurement(1,3 and 6 months post-operation.)
研究者
AYSE HUMEYRA ORUC
research assistant
Necmettin Erbakan University