Oral SurgeryMUCODANCT04390620
Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)
An observational study of Oral Surgery and Tooth Extraction, run by Aesculap AG at 2 sites in 2 countries.
Trial summary
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Surgery, Tooth Extraction, Dental Implants
- What is being tested?
- Mucosal Closure
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 105 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jul 2020to 14 Apr 2021
- 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
Who may be able to join
- Adult patients undergoing mucosal wound closure using Dafilon 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 included).
- Written informed consent regarding the data collection for the PMCF.
Who cannot join
- Emergency surgery.
- Oral surgery procedures requiring bone regeneration.
- Pregnancy.
- Patients taking medication that might affect wound healing.
- Patients with hypersensitivity or allergy to the suture material.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie
Esslingen am Neckar, 73728
About this study
Official title: Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients
Read the detailed description
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients.
The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Dafilon 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 10 ± 5 days post-operatively (and post-operatively depending on routine clinical practice of each hospital).
- Conditions
- Oral Surgery, Tooth Extraction, Dental Implants
- Being tested
- Mucosal Closure
- Keywords
- oral surgery, mucosal closure, complication rate
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 |
|---|---|---|
| MUCODA | DAFILON - sterile, monofilament, non-absorbable surgical suture material produced from Polyamide Receives: Device: Mucosal Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of combined postoperative complications Grade I and Grade II
combined incidence of postoperative complications Grade I \& II on a Five Point scale defined by Askar et al. (Grade I: postoperative dentinal hypersensitivity / Oral candidiasis / Angular cheilitis / Exaggerated swelling defined as postoperative enlargement of tissues that exceeds the normal limits associated with a given surgical procedure / Delayed wound healing defined as an unusual deviation from the normal course of healing / Mild postoperative bleeding defined as the presence of small amount of blood in the oral cavity, usually mixed with saliva; Grade II: Flap dehiscence / Membrane exposure / Localized infection of the surgical site / Graft necrosis)
Measured: 10 ± 5 days postoperatively (suture removal)
Secondary outcomes (9)
Incidence of individual postoperative complications
incidence of postoperative complications of Grade I - V on a Five Point scale defined by Askar et al. (Grade I \& II see Primary Outcome; Grade III: Fever / Skin rash / Neuropraxia/paresthesia / Trimus / Osteomyelitis / Septicemia / Sinusitis / Alveolar osteitis / Chymosis / Excessive and severe bleeding / Prolonged exaggerated swelling; Grade IV: Major complications that required immediate hospitalization such as drug induced anaphylaxis or septicemia; Grade V: Major complications that led to irreversible damage such neurotmesis and axonotmesis)
Measured: until suture removal 10 ± 5 days postoperative
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: at suture removal 10 ± 5 days postoperative
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: at suture removal 10 ± 5 days postoperative
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: at suture removal 10 ± 5 days postoperative
knot security
Evaluation of Knot security with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
Measured: intraoperative
tensile strength
Evaluation of tensile strength with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
Measured: intraoperative
knot run down
Evaluation of knot run down with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
Measured: intraoperative
tissue drag
Evaluation of tissue drag with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
Measured: intraoperative
pliability
Evaluation of pliability with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start6 Jul 2020
- Primary completion7 Apr 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral SurgeryStudies 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
- Nils Weyer, Dr. med., Principal investigator, Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie Ästhetische und Plastische Chirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390620
- Sponsor's protocol ID
- AAG-O-H-1912
- Acronym
- MUCODA
- Status last verified
- Dec 2021
- First submitted
- 7 May 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice
- ClinicalTrials.gov ID
- NCT04390620
- Acronym / sponsor ID
- MUCODA / AAG-O-H-1912
- Conditions
- Oral Surgery, Tooth Extraction, Dental Implants
- Keywords
- oral surgery, mucosal closure, complication rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 15 May 2020 (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.
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients
Detailed description
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients.
The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Dafilon 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 10 ± 5 days post-operatively (and post-operatively depending on routine clinical practice of each hospital).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MUCODA | – | Device: Mucosal ClosureDAFILON - sterile, monofilament, non-absorbable surgical suture material produced from Polyamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (2 listed)
- Adult patients undergoing mucosal wound closure using Dafilon 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 included).
- Written informed consent regarding the data collection for the PMCF.
Key exclusion criteria (5 listed)
- Emergency surgery.
- Oral surgery procedures requiring bone regeneration.
- Pregnancy.
- Patients taking medication that might affect wound healing.
- Patients with hypersensitivity or allergy to the suture material.
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 | MUCODA |
Primary outcome
incidence of combined postoperative complications Grade I and Grade II
Time frame: 10 ± 5 days postoperatively (suture removal)
combined incidence of postoperative complications Grade I \& II on a Five Point scale defined by Askar et al. (Grade I: postoperative dentinal hypersensitivity / Oral candidiasis / Angular cheilitis / Exaggerated swelling defined as postoperative enlargement of tissues that exceeds the normal limits associated with a given surgical procedure / Delayed wound healing defined as an unusual deviation from the normal course of healing / Mild postoperative bleeding defined as the presence of small amount of blood in the oral cavity, usually mixed with saliva; Grade II: Flap dehiscence / Membrane exposure / Localized infection of the surgical site / Graft necrosis)
9 secondary outcomes
Incidence of individual postoperative complications
Time frame: until suture removal 10 ± 5 days postoperative
Pain assessment using the visual analogue scale (VAS 1-100)
Time frame: at suture removal 10 ± 5 days postoperative
Satisfaction of the patient using the visual analogue scale (VAS 1-100)
Time frame: at suture removal 10 ± 5 days postoperative
Wound healing assessment using the visual analogue scale (VAS 1-100)
Time frame: at suture removal 10 ± 5 days postoperative
knot security
Time frame: intraoperative
tensile strength
Time frame: intraoperative
knot run down
Time frame: intraoperative
tissue drag
Time frame: intraoperative
pliability
Time frame: intraoperative
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 22 Dec 2021.
Related trials for Oral Surgery
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 2
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
Oral and Maxillofacial Conditions
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Nils Weyer, Dr. med. principal investigator
Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie Ästhetische und Plastische Chirurgie
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Surgery and Tooth Extraction, run by Aesculap AG at 2 sites in 2 countries.
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 2 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 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, 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?
incidence of combined postoperative complications Grade I and Grade II (time frame: 10 ± 5 days postoperatively (suture removal)). 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 22 Dec 2021.