Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Bacterial contamination of the thread |
optional |
at suture removal 10 ± 5 days postoperative |
|
| Other |
Pain assessment using the visual analogue scale (VAS 1-100) |
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". |
at follow-up up to five months postoperative |
|
| Other |
Satisfaction of the patient using the visual analogue scale (VAS 1-100) |
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". |
at follow-up up to five months postoperative |
|
| Other |
Wound healing assessment using the visual analogue scale (VAS 1-100) |
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". |
at follow-up up to five months postoperative |
|
| Other |
Cosmetic outcome assessed by the physician using the visual analogue scale (VAS 1-100) |
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". |
at follow-up up to five months postoperative |
|
| Primary |
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) |
10 ± 5 days postoperatively (suture removal) |
|
| Secondary |
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) |
until suture removal 10 ± 5 days postoperative |
|
| Secondary |
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". |
at suture removal 10 ± 5 days postoperative |
|
| Secondary |
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". |
at suture removal 10 ± 5 days postoperative |
|
| Secondary |
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". |
at suture removal 10 ± 5 days postoperative |
|
| Secondary |
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, |
intraoperative |
|
| Secondary |
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, |
intraoperative |
|
| Secondary |
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, |
intraoperative |
|
| Secondary |
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, |
intraoperative |
|
| Secondary |
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, |
intraoperative |
|
