Patient-Reported Outcomes of Four Intraoral Suture Materials

April 28, 2026 updated by: Omar Amjad Karadsheh, University of Jordan

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Silk Suture (Braided, Non-absorbable)
4-0 Black Braided Silk suture. Used for soft tissue approximation.
Device: Polyglactin 910 Suture (Braided, Absorbable)
4-0 Synthetic braided absorbable suture (e.g., Vicryl).
Device: Polyamide Suture (Monofilament, Non-absorbable)
4-0 Nylon monofilament suture.
Device: Poliglecaprone 25 Suture (Monofilament, Absorbable)
4-0 Synthetic monofilament absorbable suture (e.g., Monocryl).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Pain and Discomfort (VAS)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Healing Index Score
Time Frame: 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
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Collaborators

Jordan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2046
  • 158/2025-2026 (Other Grant/Funding Number: The University of Jordan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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