Patient-Reported Outcomes Following Application of Intraoral Sutures: A Split-Mouth Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Patient-Reported Pain and Discomfort (VAS)
研究概览
简要总结
When patients undergo minor oral surgery, dentists use various types of stitches (sutures) to help the gums heal. These stitches can be made of different materials, and some might feel more comfortable, cause less pain, or interfere less with eating and speaking than others.
The purpose of this study is to compare four commonly used dental suture materials to see which ones patients prefer. Participants in this study will receive four different types of stitches in different areas of their upper jaw after a routine dental procedure.
Patients will be asked to report their levels of pain, discomfort, and any difficulties with daily activities like eating and talking on Days 3, 7, and 14 after the procedure. A panel of dental specialists will also examine photos of the healing process to see if one material helps the mouth heal better than others. This research will help dentists choose the best materials to improve patient comfort after oral surgery.
详细描述
Study Design:
This is a split-mouth, randomized controlled clinical trial designed to evaluate patient-reported outcome measures (PROMs) and clinical healing associated with four different intraoral suture materials.
Methodology:
A total of 60 participants requiring multiple sutures in the maxillary arch will be recruited. Following the surgical procedure under local anesthesia, four types of sutures (e.g., Silk, Polyglactin 910, Polyamide, and Poliglecaprone 25) will be placed in a randomized sequence across four standardized sites in a single hemi-arch:
Site A: Anterior Buccal
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Although labeled as 'Open Label' for system configuration, this is a split-mouth design where both the participant and the outcomes assessor are blinded. Participants are unaware of which specific suture material is assigned to each of the four intraoral sites. The outcomes assessor evaluates de-identified clinical photographs to ensure a fully blinded assessment of healing outcomes.
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 20-30 years.
- •Systemically healthy (ASA I-II).
- •No history of allergy to study suture materials.
- •Periodontally healthy, with no active oral lesions, including carious lesions.
- •Dental Requirements: All maxillary canine, second premolar, and first molar teeth present.
- •Minimal (≤0.5 mm) open contacts between the pairs of teeth that define the study sites.
- •Ideally, full maxillary dentition present from first molar to first molar.
- •At least 2 mm of keratinized tissue width on buccal intervention sites.
- •Willing and able to provide informed consent.
- •Willing and able to attend all study follow-up visits and complete study questionnaires.
排除标准
- •Allergy to any study materials (e.g., suture materials or anesthetics) or medications (Paracetamol).
- •Any systemic disease affecting wound healing (e.g., diabetes, immunosuppression).
- •Use of any medications.
- •Pregnancy or lactation.
- •Unwillingness or inability to provide informed consent.
- •Unwillingness or inability to comply with study protocol and follow-up visits.
- •Exit Criteria:
- •Participants may exit the study at any time if they wish to discontinue participation.
- •Noncompliance with study protocol and visits.
- •Development of conditions (e.g., infection) that require immediate care or that introduce exclusion criteria.
研究组 & 干预措施
Suture Comparison Group
A single group of 60 participants. Each participant serves as their own control (split-mouth design). Every participant will receive four different suture materials placed in four distinct sites (Anterior Buccal, Posterior Buccal, Anterior Palatal, Posterior Palatal) in the maxillary arch.
干预措施: Silk Suture (Braided, Non-absorbable) (Device)
Suture Comparison Group
A single group of 60 participants. Each participant serves as their own control (split-mouth design). Every participant will receive four different suture materials placed in four distinct sites (Anterior Buccal, Posterior Buccal, Anterior Palatal, Posterior Palatal) in the maxillary arch.
干预措施: Polyglactin 910 Suture (Braided, Absorbable) (Device)
Suture Comparison Group
A single group of 60 participants. Each participant serves as their own control (split-mouth design). Every participant will receive four different suture materials placed in four distinct sites (Anterior Buccal, Posterior Buccal, Anterior Palatal, Posterior Palatal) in the maxillary arch.
干预措施: Polyamide Suture (Monofilament, Non-absorbable) (Device)
Suture Comparison Group
A single group of 60 participants. Each participant serves as their own control (split-mouth design). Every participant will receive four different suture materials placed in four distinct sites (Anterior Buccal, Posterior Buccal, Anterior Palatal, Posterior Palatal) in the maxillary arch.
干预措施: Poliglecaprone 25 Suture (Monofilament, Absorbable) (Device)
结局指标
主要结局
Patient-Reported Pain and Discomfort (VAS)
时间窗: Post-operative Day 3
Subjective assessment of pain and discomfort for each of the four suture sites using a Visual Analog Scale (VAS) ranging from 0 (no pain/discomfort) to 100 (worst possible pain/discomfort).
次要结局
- Clinical Healing Index Score(Post-operative Day 7 and Day 14)
- Pain Intensity During Suture Removal(Post-operative Day 7)
- Impact on Daily Activities (Speech and Eating)(Post-operative Day 3 and Day 7)
研究者
Omar Amjad Karadsheh
Associate Professor, Department of Periodontology
University of Jordan