Tooth, ImpactedSILKOSNCT05296902
Performance of Safety of SILKAM® Suture Material in Oral Surgery
An observational study of Tooth, Impacted and Teeth Impact, run by Aesculap AG at 1 site in Spain.
Trial summary
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth, Impacted, Teeth Impact, Tooth Impaction
- What is being tested?
- Mucosal Closure
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 21 Sep 2022to 16 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients undergoing mucosal closure in oral surgery (mucosal sutures).
Who may be able to join
- Patients undergoing mucosal wound closure using SILKAM® as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be considered).
Who cannot join
- Patients taking medication that might affect wound healing
- Patients having a condition that might affect wound healing.
- Patients with hypersensitivity or allergy to the suture material.
- Participation in another (Randomized) Clinical Trial / Clinical Study.
- Non-compliance of patient (i.e. dementia).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultat D'odontologia. Universitat Internacional de Catalunya
Sant Cugat del Vallès, Catalonia, 08195
About this study
Official title: Single Center Open-Label Post Market Clinical Follow-Up (PMCF) -Study on the Performance of Safety of SILKAM® Suture Material in Oral Surgery
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
Read the detailed description
The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness, and performance of SILKAM® suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place approximately one week post-operatively.
- Conditions
- Tooth, Impacted, Teeth Impact, Tooth Impaction, Mucosal Wound
- Being tested
- Mucosal Closure
- Keywords
- Tooth distraction, Removal of impacted Teeth, Oral Surgery, Dental Implant, Observational Study
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucosal ClosureDevice
mucosal closure in oral surgery (mucosal sutures)
| Study group | Role | What they receive |
|---|---|---|
| SILKAM® | SILKAM® is a non-absorbable sterile suture material made from braided silk fibrils. It is available either undyed (white) or dyed black with hematein and is coated with refined paraffin wax or beeswax. Receives: Device: Mucosal Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Wound Dehiscence rate
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Measured: until day of suture removal (approximately 1 week after surgery)
Complication rate
Complications rate according to the "Classification of Askar" as Grade 1 (Localized complication(s) accompanied by no adverse effects on the success of the surgery) and Grade 2 (Localized complication(s) accompanied by adverse effects on the success of the surgery).
Measured: until day of suture removal (approximately 1 week after surgery)
Secondary outcomes (5)
Complication rate
Complications rate according to the "Classification of Askar" as Grade 3 (Localized or systemic complication(s) that impairs the patient's daily routine but does not require hospitalization), Grade 4 (Localized or systemic complication(s) that impairs the patient's daily routine and requires hospitalization), Grade 5 (Localized or systemic complication(s) that inflicts irreversible damage to >1 anatomical structures), or Grade 6 (Localized or systemic complication(s) that lead to death.
Measured: until day of suture removal (approximately 1 week after surgery)
Pain assessment using the visual analogue scale (VAS 1-100)
This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain".
Measured: until day of suture removal (approximately 1 week after surgery)
Satisfaction of the patient using the visual analogue scale (VAS 1-100)
This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "completely satisfied" and "100" at the opposite end representing "not at all satisfied".
Measured: until day of suture removal (approximately 1 week after surgery)
Wound healing assessment using the visual analogue scale (VAS 1-100)
This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good wound healing" and "100" at the opposite end representing "very bad wound healing".
Measured: until day of suture removal (approximately 1 week after surgery)
Assessment of the handling of the suture material
Evaluation of the handling of the suture material in five categories (Knot security, Knot run down, Knot pull tensile strength, Tissue drag, Pliability) with the 5 evaluation levels each: 'excellent', 'very good', 'good', 'satisfied' and 'poor' transferred into the evaluation scores 5, 4, 3, 2 and 1.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start21 Sep 2022
- Primary completion21 Oct 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Marc Quevedo Pou, Dr., Principal investigator, Facultat D'odontologia. Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296902
- Sponsor's protocol ID
- AAG-O-H-2038
- Acronym
- SILKOS
- Status last verified
- Feb 2024
- First submitted
- 16 Mar 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Open-Label Post Market Clinical Follow-Up (PMCF) -Study on the Performance of Safety of SILKAM® Suture Material in Oral Surgery
- ClinicalTrials.gov ID
- NCT05296902
- Acronym / sponsor ID
- SILKOS / AAG-O-H-2038
- Conditions
- Tooth, Impacted, Teeth Impact, Tooth Impaction, Mucosal Wound
- Keywords
- Tooth distraction, Removal of impacted Teeth, Oral Surgery, Dental Implant, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 25 Mar 2022 (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.
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
Detailed description
The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness, and performance of SILKAM® suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place approximately one week post-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SILKAM® | – | Device: Mucosal ClosureSILKAM® is a non-absorbable sterile suture material made from braided silk fibrils. It is available either undyed (white) or dyed black with hematein and is coated with refined paraffin wax or beeswax. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing mucosal closure in oral surgery (mucosal sutures).
Key inclusion criteria (1 listed)
- Patients undergoing mucosal wound closure using SILKAM® as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be considered).
Key exclusion criteria (5 listed)
- Patients taking medication that might affect wound healing
- Patients having a condition that might affect wound healing.
- Patients with hypersensitivity or allergy to the suture material.
- Participation in another (Randomized) Clinical Trial / Clinical Study.
- Non-compliance of patient (i.e. dementia).
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 |
|---|---|---|
| Mucosal Closuremucosal closure in oral surgery (mucosal sutures) | Device | SILKAM® |
Primary outcome
Surgical Wound Dehiscence rate
Time frame: until day of suture removal (approximately 1 week after surgery)
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Complication rate
Time frame: until day of suture removal (approximately 1 week after surgery)
Complications rate according to the "Classification of Askar" as Grade 1 (Localized complication(s) accompanied by no adverse effects on the success of the surgery) and Grade 2 (Localized complication(s) accompanied by adverse effects on the success of the surgery).
5 secondary outcomes
Complication rate
Time frame: until day of suture removal (approximately 1 week after surgery)
Pain assessment using the visual analogue scale (VAS 1-100)
Time frame: until day of suture removal (approximately 1 week after surgery)
Satisfaction of the patient using the visual analogue scale (VAS 1-100)
Time frame: until day of suture removal (approximately 1 week after surgery)
Wound healing assessment using the visual analogue scale (VAS 1-100)
Time frame: until day of suture removal (approximately 1 week after surgery)
Assessment of the handling of the suture material
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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. This study is not recruiting at the moment.
Marc Quevedo Pou, Dr. principal investigator
Facultat D'odontologia. Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth, Impacted and Teeth Impact, run by Aesculap AG at 1 site in Spain.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical Wound Dehiscence rate (time frame: until day of suture removal (approximately 1 week after surgery)). 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 20 Feb 2024.