Dental Implants, Oral Surgery, Tooth Extraction
Conditions
Keywords
oral surgery, mucosal closure, complication rate
Brief 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
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).
Interventions
DEVICEMucosal Closure
mucosal closure in oral surgery (mucosal sutures)
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of combined postoperative complications Grade I and Grade II | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of the patient using the visual analogue scale (VAS 1-100) | at suture removal 10 ± 5 days postoperative | 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. |
| knot security | intraoperative | 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, |
| tensile strength | intraoperative | 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, |
| knot run down | intraoperative | 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, |
| tissue drag | intraoperative | 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, |
| pliability | intraoperative | 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, |
| Incidence of individual postoperative complications | until suture removal 10 ± 5 days postoperative | 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) |
| Pain assessment using the visual analogue scale (VAS 1-100) | at suture removal 10 ± 5 days postoperative | 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. |
| Wound healing assessment using the visual analogue scale (VAS 1-100) | at suture removal 10 ± 5 days postoperative | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of the patient using the visual analogue scale (VAS 1-100) | at follow-up up to five months postoperative | Optional: 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. |
| Wound healing assessment using the visual analogue scale (VAS 1-100) | at follow-up up to five months postoperative | Optional: 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. |
| Cosmetic outcome assessed by the physician using the visual analogue scale (VAS 1-100) | at follow-up up to five months postoperative | Optional: This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state 0 at one end representing very good cosmetic outcome and 100 at the opposite end representing very bad cosmetic outcome. |
| Bacterial contamination of the thread | at suture removal 10 ± 5 days postoperative | optional |
| Pain assessment using the visual analogue scale (VAS 1-100) | at follow-up up to five months postoperative | Optional: 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. |
Countries
Germany, Spain
Outcome results
None listed