Wound Healing ComplicationNCT06864559
Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study
A study testing To Compare 3 different suture materials used in oral surgery in people with Wound Healing Complication and Oral Surgery, run by Universidad de Granada.
Trial summary
Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing Complication, Oral Surgery, Third Molar Extraction
- What is being tested?
- To Compare 3 different suture materials used in oral surgery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indication for extraction of a third lower molar retained in an unfavorable position that requires a bayonet incision in the surgical procedure.
- Age: patients aged 18 years or older.
- ASA I patients (Classification of the American Society of Anesthesiology, 1979): healthy patients who tolerate stress well, without systemic pathology, no anxiety and in whom a therapeutic modification is not necessary.
Who cannot join
- Pregnant or breastfeeding women.
- Smoking patients.
About this study
Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded polytetrafluoroethylene).
Read the detailed description
The general or primary objective is:
- To compare 3 non-absorbable suture materials used in oral surgery: silk, polyamide monofilament and expanded polytetrafluoroethylene.
The specific or secondary objectives are:
- To evaluate how each type of suture influences wound healing and the patient's postoperative period.
- To study bacterial colonization in each type of suture.
- To determine the tissue reaction and clinical characteristics of each suture.
- Being tested
- To Compare 3 different suture materials used in oral surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To Compare 3 different suture materials used in oral surgeryOther
Also called 2028/CEIH/2021
To compare bacterial colonization, tissue reaction and clinical characteristics such as wound healing and patient postoperative outcomes in 3 different suture materials used in oral surgery.
| Study group | Role | What they receive |
|---|---|---|
| Suture 1: Silk. | Other | Silk suture. Receives: Other: To Compare 3 different suture materials used in oral surgery |
| Suture 2: Non-absorbable polyamide monofilament. | Other | Non-absorbable polyamide monofilament. Receives: Other: To Compare 3 different suture materials used in oral surgery |
| Suture 3: Non-resorbable expanded polytetrafluoroethylene. | Other | Non-resorbable expanded polytetrafluoroethylene. Receives: Other: To Compare 3 different suture materials used in oral surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colonization
Microbiological analysis: CFU and qPCR bacterial count.
Measured: 7 days.
Level of inflammation
The degree of soft tissue inflammation was assessed using Visual Analogue Scale (VAS).
Measured: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Manuel Alarcón Cordovilla, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864559
- Sponsor's protocol ID
- 2028/CEIH/2021
- Status last verified
- Mar 2025
- First submitted
- 22 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06864559
- Acronym / sponsor ID
- 2028/CEIH/2021
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Mar 2025 (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.
Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded polytetrafluoroethylene).
Detailed description
The general or primary objective is:
- To compare 3 non-absorbable suture materials used in oral surgery: silk, polyamide monofilament and expanded polytetrafluoroethylene.
The specific or secondary objectives are:
- To evaluate how each type of suture influences wound healing and the patient's postoperative period.
- To study bacterial colonization in each type of suture.
- To determine the tissue reaction and clinical characteristics of each suture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suture 1: Silk. | Other | Other: To Compare 3 different suture materials used in oral surgerySilk suture. |
| Suture 2: Non-absorbable polyamide monofilament. | Other | Other: To Compare 3 different suture materials used in oral surgeryNon-absorbable polyamide monofilament. |
| Suture 3: Non-resorbable expanded polytetrafluoroethylene. | Other | Other: To Compare 3 different suture materials used in oral surgeryNon-resorbable expanded polytetrafluoroethylene. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with indication for extraction of a third lower molar retained in an unfavorable position that requires a bayonet incision in the surgical procedure.
- Age: patients aged 18 years or older.
- ASA I patients (Classification of the American Society of Anesthesiology, 1979): healthy patients who tolerate stress well, without systemic pathology, no anxiety and in whom a therapeutic modification is not necessary.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women.
- Smoking patients.
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 |
|---|---|---|
| To Compare 3 different suture materials used in oral surgeryAlso: 2028/CEIH/2021To compare bacterial colonization, tissue reaction and clinical characteristics such as wound healing and patient postoperative outcomes in 3 different suture materials used in oral surgery. | Other | Suture 1: Silk., Suture 2: Non-absorbable polyamide monofilament., Suture 3: Non-resorbable expanded polytetrafluoroethylene. |
Primary outcome
Bacterial colonization
Time frame: 7 days.
Microbiological analysis: CFU and qPCR bacterial count.
Level of inflammation
Time frame: 7 days.
The degree of soft tissue inflammation was assessed using Visual Analogue Scale (VAS).
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 7 Mar 2025.
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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 To Compare 3 different suture materials used in oral surgery in people with Wound Healing Complication and Oral Surgery, run by Universidad de Granada.
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 3 inclusion and 2 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 7 Mar 2025. 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?
Bacterial colonization (time frame: 7 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2025.