Patient-Reported Outcomes of Four Intraoral Suture Materials
Patient-Reported Outcomes Following Application of Intraoral Sutures: A Split-Mouth Randomized Controlled Trial
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
4-0 Black Braided Silk suture.
Used for soft tissue approximation.
4-0 Synthetic braided absorbable suture (e.g., Vicryl).
4-0 Nylon monofilament suture.
4-0 Synthetic monofilament absorbable suture (e.g., Monocryl).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient-Reported Pain and Discomfort (VAS)
Délai: 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).
|
Post-operative Day 3
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Healing Index Score
Délai: Post-operative Day 7 and Day 14
|
Evaluation of soft tissue healing at each suture site using the Landry, Turnbull, and Howley Index (scores 1-5).
Assessment will be performed by a blinded panel using standardized clinical photographs.
|
Post-operative Day 7 and Day 14
|
|
Pain Intensity During Suture Removal
Délai: Post-operative Day 7
|
Subjective pain level reported by the participant specifically during the process of removing the sutures at Day 7, measured on a 0-100 VAS.
|
Post-operative Day 7
|
|
Impact on Daily Activities (Speech and Eating)
Délai: Post-operative Day 3 and Day 7
|
Patient-reported difficulty in speaking and eating caused by the sutures, measured on a Likert-type scale (0-10).
|
Post-operative Day 3 and Day 7
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2046
- 158/2025-2026 (Autre subvention/numéro de financement: The University of Jordan)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .