Patient-Reported Outcomes of Four Intraoral Suture Materials

NCT07569237 | Not Yet Recruiting

• 2 other identifiers: 2046158/2025-2026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Suture Materials; Wound Healing; Patient Comfort; Oral Health-Related Quality of Life

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

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Pain and Discomfort (VAS)

  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

Secondary Outcomes (3)

• 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

Study Arms (1)

Suture Comparison Group

EXPERIMENTAL

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.

Device: Silk Suture (Braided, Non-absorbable); Device: Polyglactin 910 Suture (Braided, Absorbable); Device: Polyamide Suture (Monofilament, Non-absorbable); Device: Poliglecaprone 25 Suture (Monofilament, Absorbable)

Interventions

Polyglactin 910 Suture (Braided, Absorbable) DEVICE

4-0 Synthetic braided absorbable suture (e.g., Vicryl).

Suture Comparison Group

Poliglecaprone 25 Suture (Monofilament, Absorbable) DEVICE

4-0 Synthetic monofilament absorbable suture (e.g., Monocryl).

Suture Comparison Group

Silk Suture (Braided, Non-absorbable) DEVICE

4-0 Black Braided Silk suture. Used for soft tissue approximation.

Suture Comparison Group

Polyamide Suture (Monofilament, Non-absorbable) DEVICE

4-0 Nylon monofilament suture.

Suture Comparison Group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead
• Jordan University Hospital: collaborator

Related Publications (1)

• 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 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Periodontology

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share