Suture MaterialsNCT07569237
Patient-Reported Outcomes of Four Intraoral Suture Materials
A study testing Silk Suture (Braided, Non-absorbable), Polyglactin 910 Suture (Braided, Absorbable) and Polyamide Suture (Monofilament, Non-absorbable) in people with Suture Materials and Wound Healing, run by University of Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Suture Materials, Wound Healing, Patient Comfort
- What is being tested?
- Silk Suture (Braided, Non-absorbable), Polyglactin 910 Suture (Braided, Absorbable) and Polyamide Suture (Monofilament, Non-absorbable)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- Silk Suture (Braided, Non-absorbable), Polyglactin 910 Suture (Braided, Absorbable), Polyamide Suture (Monofilament, Non-absorbable), Poliglecaprone 25 Suture (Monofilament, Absorbable)
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk Suture (Braided, Non-absorbable)Device
4-0 Black Braided Silk suture. Used for soft tissue approximation.
Polyglactin 910 Suture (Braided, Absorbable)Device
4-0 Synthetic braided absorbable suture (e.g., Vicryl).
Polyamide Suture (Monofilament, Non-absorbable)Device
4-0 Nylon monofilament suture.
Poliglecaprone 25 Suture (Monofilament, Absorbable)Device
4-0 Synthetic monofilament absorbable suture (e.g., Monocryl).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Silk Suture (Braided, Non-absorbable); Device: Polyglactin 910 Suture (Braided, Absorbable); Device: Polyamide Suture (Monofilament, Non-absorbable); Device: Poliglecaprone 25 Suture (Monofilament, Absorbable) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-operative Day 3
Secondary outcomes (3)
Clinical Healing Index Score
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.
Measured: Post-operative Day 7 and Day 14
Pain Intensity During Suture Removal
Subjective pain level reported by the participant specifically during the process of removing the sutures at Day 7, measured on a 0-100 VAS.
Measured: Post-operative Day 7
Impact on Daily Activities (Speech and Eating)
Patient-reported difficulty in speaking and eating caused by the sutures, measured on a Likert-type scale (0-10).
Measured: Post-operative Day 3 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startJul 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suture MaterialsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University Hospital
- Responsible party
- Principal investigator, Omar Amjad Karadsheh, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569237
- Sponsor's protocol ID
- 2046
- Other IDs
- 158/2025-2026
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41638849
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes Following Application of Intraoral Sutures: A Split-Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07569237
- Acronym / sponsor ID
- 2046
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Jordan University Hospital
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Suture Comparison Group | Experimental | Device: Silk Suture (Braided, Non-absorbable), Device: Polyglactin 910 Suture (Braided, Absorbable), Device: Polyamide Suture (Monofilament, Non-absorbable), Device: Poliglecaprone 25 Suture (Monofilament, Absorbable)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. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silk Suture (Braided, Non-absorbable)4-0 Black Braided Silk suture. Used for soft tissue approximation. | Device | Suture Comparison Group |
| Polyglactin 910 Suture (Braided, Absorbable)4-0 Synthetic braided absorbable suture (e.g., Vicryl). | Device | Suture Comparison Group |
| Polyamide Suture (Monofilament, Non-absorbable)4-0 Nylon monofilament suture. | Device | Suture Comparison Group |
| Poliglecaprone 25 Suture (Monofilament, Absorbable)4-0 Synthetic monofilament absorbable suture (e.g., Monocryl). | Device | Suture Comparison Group |
Primary outcome
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).
3 secondary outcomes
Clinical Healing Index Score
Time frame: Post-operative Day 7 and Day 14
Pain Intensity During Suture Removal
Time frame: Post-operative Day 7
Impact on Daily Activities (Speech and Eating)
Time frame: Post-operative Day 3 and Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 41638849Fang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Silk Suture (Braided, Non-absorbable), Polyglactin 910 Suture (Braided, Absorbable) and Polyamide Suture (Monofilament, Non-absorbable) in people with Suture Materials and Wound Healing, run by University of Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Pain and Discomfort (VAS) (time frame: Post-operative Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07569237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.