Oral Health-Related Quality of Life, Patient Comfort, Suture Materials, Wound Healing
Conditions
Keywords
Split-mouth design, Patient-reported outcome measures (PROMs), Intraoral sutures, Dental surgery, Visual Analog Scale (VAS), Periodontology, Oral surgery healing, Braided vs Monofilament sutures
Brief summary
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.
Detailed description
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.
Interventions
DEVICESilk Suture (Braided, Non-absorbable)
4-0 Black Braided Silk suture. Used for soft tissue approximation.
DEVICEPolyglactin 910 Suture (Braided, Absorbable)
4-0 Synthetic braided absorbable suture (e.g., Vicryl).
DEVICEPolyamide Suture (Monofilament, Non-absorbable)
4-0 Nylon monofilament suture.
DEVICEPoliglecaprone 25 Suture (Monofilament, Absorbable)
4-0 Synthetic monofilament absorbable suture (e.g., Monocryl).
Sponsors
University of Jordan
Jordan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
A within-person, split-mouth randomized controlled trial. Each participant receives four 4-0 suture materials (Silk, Polyglactin 910, Polyamide, and Poliglecaprone) at standardized maxillary sites. Randomization is applied to the site location of each material within the individual participant's mouth, rather than to the participants themselves.
Eligibility
Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Pain and Discomfort (VAS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Healing Index Score | 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. |
| Pain Intensity During Suture Removal | 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. |
| Impact on Daily Activities (Speech and Eating) | 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). |
Outcome results
None listed