Patient-Reported Outcomes of Four Intraoral Suture Materials

Официальное название

Patient-Reported Outcomes Following Application of Intraoral Sutures: A Split-Mouth Randomized Controlled Trial

Обзор

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.

Подробное описание

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

Site B: Posterior Buccal

Site C: Anterior Palatal

Site D: Posterior Palatal

Randomization and Blinding:

Suture materials will be assigned to sites using a computer-generated randomization table. The study is single-blinded; patients will not be informed which material is placed at which site. A blinded panel of three periodontists will evaluate clinical healing via standardized digital photographs.

Data Collection:

Patient-Reported Outcomes: Participants will complete a Visual Analog Scale (VAS) and Likert-type scales to assess pain, awareness of the suture, tissue irritation, and functional interference (speaking and eating) on post-operative Days 3, 7, and 14.

Suture Removal: Pain during suture removal will be recorded at Day 7.

Clinical Healing: Healing will be assessed by the expert panel using the Landry, Turnbull, and Howley Index (1988) based on photographs taken at Day 7 and Day 14.

Primary Objective:

To identify which suture material provides the highest level of patient comfort and the least functional interference during the first two weeks of healing.

Secondary Objective:

To compare the clinical tissue response and healing scores between braided and monofilament suture materials in the oral cavity.

Вмешательства

• Устройство Silk Suture (Braided, Non-absorbable)
  4-0 Black Braided Silk suture. Used for soft tissue approximation.
• Устройство Polyglactin 910 Suture (Braided, Absorbable)
  4-0 Synthetic braided absorbable suture (e.g., Vicryl).
• Устройство Polyamide Suture (Monofilament, Non-absorbable)
  4-0 Nylon monofilament suture.
• Устройство Poliglecaprone 25 Suture (Monofilament, Absorbable)
  4-0 Synthetic monofilament absorbable suture (e.g., Monocryl).

Первичные конечные точки

• Patient-Reported Pain and Discomfort (VAS) [Срок оценки: Post-operative Day 3]

Вторичные конечные точки (3)

• Clinical Healing Index Score [Срок оценки: Post-operative Day 7 and Day 14]
• Pain Intensity During Suture Removal [Срок оценки: Post-operative Day 7]
• Impact on Daily Activities (Speech and Eating) [Срок оценки: Post-operative Day 3 and Day 7]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Fang QH, Taneja P. Vicryl vs silk suture in lower third molar surgery: A systematic review. Curr Probl Surg. 2026 Feb;75:101958. doi: 10.1016/j.cpsurg.2025.101958. Epub 2025 Dec 13. No abstract available. PMID 41638849

Идентификаторы

NCT: NCT07569237 · 2046 · 158/2025-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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