The Role of Enamel Matrix Derivative in Reducing the Periodontal Defect Distal to the Mandibular Second Molar Following Surgical Extraction of the Third Molar
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Clinical Attachment Level (CAL)
研究概览
简要总结
This study investigates whether the intraoperative application of a specialized regenerative gel (Emdogain®) can improve the periodontal health of the mandibular second molar by preventing or reducing the formation of tissue defects after the surgical removal of an adjacent impacted lower wisdom tooth.
Surgical extraction of a lower wisdom tooth frequently leaves a deep pocket or a permanent hard and/or soft tissue defect on the back side of the neighboring second molar. This defect compromise the surrounding tissues and predispose the healthy second molar to future complications like root caries, dentin hypersensitivity, or localized gum disease. While most existing treatments address these defects after they have formed, this trial evaluates a site-specific preventive approach during the extraction process itself.
The study will involve 70 systemically healthy adults (ages 18-45) requiring surgical removal of a horizontally or mesially oriented impacted lower third molar. Participants will be randomized into two equal groups:
The Test Group: Will receive root conditioning with PrefGel and a single application of Emdogain® gel directly to the root surface and socket immediately after tooth removal.
The Control Group: Will undergo identical surgery but will follow a natural, spontaneous healing process without the application of any biomaterials.
The main objective is to measure changes in Clinical Attachment Level (CAL) at the distal aspects of the second molar using stable vertical anatomical reference points over a 6-month period. The trial will also monitor secondary healing parameters, including probing pocket depths, gum recession, radiographic bone level changes using standardized jigs, postoperative pain, swelling, and early tissue healing dynamics.
详细描述
The primary objective of this two-center, parallel-group, randomized clinical trial is to investigate whether the intraoperative application of Enamel Matrix Derivative (EMD) can improve the long-term periodontal health of the mandibular second molar by preventing or minimizing the formation of distal tissue defects following third molar surgery. While the regenerative properties of EMD are well-documented in periodontology, the novelty of this study lies in its prophylactic, site-specific usage at the immediate time of extraction.
Methodology and Standardization
To maximize data reproducibility and minimize measurement errors, the study incorporates the following rigorous standardization protocols:
Anatomical Selection: To control for surgical site variables and baseline defect morphology, inclusion is strictly limited to patients presenting with horizontally or mesially oriented impacted mandibular third molars.
Clinical Measurement Protocol: Clinical parameters are recorded at seven distinct sites around the mandibular second molar: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual, and mid-distal. Because the adjacent third molar, the surrounding soft tissue, and limited clinical visibility obscure the distal cementoenamel junction (CEJ) preoperatively, stable and reproducible vertical anatomical landmarks are utilized as reference points for all measurements adjacent to the extraction defect. The disto-buccal site is measured from the distal-buccal cusp tip; the disto-lingual site is measured from the distal-lingual cusp tip; and the mid-distal site is measured from the permanent occlusal (masticatory) surface of the second molar. The remaining four sites (mesio-buccal, mid-buccal, mesio-lingual, and mid-lingual) will be measured from the standard CEJ landmark as usual.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are masked to their group allocation; they are informed during the consent process that they have a 50% chance of receiving the biomaterial, but they are not told their actual assignment during or after the surgery. The primary investigator/surgeon cannot be masked and will perform the clinical periodontal probing. However, to minimize bias, masking is applied to the Outcomes Assessors evaluating the secondary data: three independent observers, who are completely blinded to the patients' group allocations, will evaluate all standardized radiographs and clinical photographs to determine hard and soft tissue outcomes.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adult patients aged 18 to 35 years old (ASA I or II).
- •Presence of an asymptomatic, partially or fully impacted mandibular third molar requiring surgical extraction.
- •The third molar impaction must be mesioangular or horizontal, with its crown in direct physical contact with the adjacent second molar, as assessed by a preoperative panoramic radiograph.
- •The adjacent mandibular second molar must be vital, fully erupted, and structurally sound (free of extensive dental caries or prosthetic crowns).
- •Patients must demonstrate an adequate level of overall oral hygiene and gingival health (e.g., Full-Mouth Plaque Index < 20% and Full-Mouth Bleeding Score < 20% following initial prophylaxis and oral hygiene instructions).
- •Willingness to comply with postoperative instructions and adhere to the scheduled follow-up visits.
- •Ability to understand the study procedures and voluntarily sign the informed consent form.
排除标准
- •Presence of systemic diseases or conditions that could compromise wound healing or periodontal health (e.g., uncontrolled diabetes mellitus, autoimmune disorders).
- •Current or recent use of medications known to affect bone metabolism or wound healing (e.g., bisphosphonates, long-term systemic corticosteroids, immunosuppressants).
- •History of heavy smoking (e.g., >10 cigarettes per day) or use of smokeless tobacco products.
- •Pregnant or lactating females.
- •Diagnosis of periodontitis (Stage II, III, or IV) affecting the remaining dentition, excluding the localized defect associated with the impacted third molar.
- •Presence of active acute infection (e.g., purulent pericoronitis) or radiolucent pathologic lesions extending beyond the normal follicular space (e.g., dentigerous cysts) that would significantly alter the baseline bony defect morphology.
- •Known allergy or hypersensitivity to any of the medications utilized in the surgical or postoperative protocol (e.g., local anesthetics, prescribed antibiotics, or analgesics).
- •Previous orthodontic treatment utilizing bands on the mandibular second molars that could have affected the periodontal attachment.
结局指标
主要结局
Change in Clinical Attachment Level (CAL)
时间窗: Baseline (immediately prior to surgery) and 6 months post-surgery
Clinical Attachment Level (CAL) is a measurement of periodontal health indicating the position of the soft tissue attachment on the tooth root, measured in millimeters (mm) using a calibrated periodontal probe. It will be recorded at seven distinct sites on the mandibular second molar. For the distal sites directly adjacent to the extraction socket, fixed coronal reference points will be used to calculate relative CAL, as the cementoenamel junction (CEJ) is often compromised by the impaction. For the remaining four sites on the second molar, the standard CEJ will be utilized as the fixed anatomical reference point. A reduction in the distance from these reference points to the base of the periodontal pocket over time indicates a clinical gain of tissue attachment and successful healing.
次要结局
- Change in Radiographic Alveolar Bone Level(Baseline (immediate post-operative) and 6 months post-surgery)
- Change in Probing Pocket Depth (PPD)(Baseline (immediately prior to surgery) and 6 months post-surgery)
- Change in Gingival Recession (REC)(Baseline and 6 months post-surgery)
- Change in Bleeding on Probing (BOP)(Baseline and 6 months post-surgery)
- Change in Plaque Index (PI)(Baseline and 6 months post-surgery)
- Postoperative Facial Oedema(Baseline (pre-operative) and 7 days post-surgery)
- Postoperative Trismus (Maximum Interincisal Opening)(Baseline (pre-operative) and 7 days post-surgery)
- Postoperative Pain(Daily for the first 7 days post-surgery)
- Oral Health-Related Quality of Life (OHIP-14)(Baseline (pre-operative), 7 days post-surgery and 6 months post-surgery)
- Change in Sleep Quality(Baseline (pre-operative) and 7 days post-surgery)
研究者
Ioulianos Apessos
Dentist - Oral Surgeon DDS, MD, MSc (Sleep Medicine), MSc (Oral Surgery), PhD candidate
Aristotle University Of Thessaloniki