Suture Materials
Conditions
Brief summary
Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Therefore, oral surgery has specific demands for suture materials. Aim: The primary objective of this study was to compare the bacterial load on different suture materials. The secondary objective was to determine the impact of suture material on decubitus. Material & methods: This prospective experimental study with a 'split-mouth' design enrolled 36 patients requiring oral surgery. Five different suture materials were compared regarding their microbiological load and decubitus at the suture removal. Bacterial accumulation on the same 5 suture materials was also tested in an in vitro biofilm model.
Interventions
DEVICESilk 4.0
Silk suture 4.0
DEVICEPG 910 4.0
PG 910 4.0
DEVICEPP 4.0
PP 4.0
DEVICESilk 5.0
Silk 5.0
DEVICEPG910 5.0
PG910 5.0
DEVICEPP 5.0
PP 5.0
DEVICEAPG 5.0
APG 5.0
DEVICEePTFE 5.0
ePTFE 5.0
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 36 patients * in need for periodontal surgery * patients in good general health * able to sign IC form
Exclusion criteria
* patients that were deemed unlikely to comply with the study protocol, as judged by the examiner * patients who had a present alcohol and/or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accumulation of soft deposits | 7 to 14 days | Accumulation of soft deposits on each suture material was assessed visually as being present or absent before removing the knots. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area of inflammation | 7 to 14 days | Clinical photographs were taken, calibrated with a ruler of 0.5 mm accuracy as is illustrated in Figure 2, before and after suture removal in both parts of the clinical study. Subsequently, the area of inflammation surrounding the sutures was measured by two separate examiners using the image-analysis program, Image J® (NIH, Bethesda, Maryland, USA). |
| Microbial deposits on the sutures | 7 to 14 days | The composition of the microbial deposits on the suture materials was examined with qPCR. |
Outcome results
None listed