NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
The aim of this study is to prove that Novosyn Quick and Monosyn Quick are equivalent in early wound healing in adult patients undergoing resective periodontal surgery.
In order to show equivalence between Novosyn Quick and Monosyn Quick EHS, which is composed of 3 parameters: clinical signs of reepithelization, clinical signs of haemostasis and clinical signs of inflammation, will be calculated for each suture 10 ± 5 days postoperatively and cannot differ more than 2 points.
Furthermore, complications, the handling of the suture material, pain, satisfaction of the patient and bacterial contamination of the thread (optional) will also be assessed as secondary objectives.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Crestal incision
Vertical incision
Intrasulcular incision
Submarginal incision
Disqualifiers
Emergency surgery.
Pregnancy.
Breastfeeding
Patients taking medication that might affect wound healing.
Trial design
Design model
Parallel
Treatments tested in this trial
Novosyn® in resective periodontal surgery
DeviceThe aim of resective procedures is the re-establishment of a healthy periodontium at a reduced level, accepting as irreversible the destruction that has already occurred. In essence, these procedures are all designed to achieve pocket elimination or reduction by the apical shift of the gingival margin.
Monosyn® in resective periodontal surgery
DeviceThe aim of resective procedures is the re-establishment of a healthy periodontium at a reduced level, accepting as irreversible the destruction that has already occurred. In essence, these procedures are all designed to achieve pocket elimination or reduction by the apical shift of the gingival margin.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Novosyn®Experimental treatment 1 intervention
Group B: Monosyn®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
early wound healing score (EHS)
The primary end point in order to evaluate the primary objective of the study will be the determination of early wound healing score (EHS) in patients undergoing resective periodontal surgery. The EHS will be evaluated in 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH), and clinical signs of inflammation (CSI). Zero, 3 or 6 points have been used to evaluate the CSR, whereas 0, 1, or 2 points have been used for both CSH and CSI (Table 3). The summation of these 3 parameters generated the EHS. The EHS for ideal wound healing was 10 points, while the worst possible score was 0 points. An EHS of 0 points was assigned in the presence of suppuration, independently of the ratings for the 3 single parameters.
Time frame
10 ± 5 days postoperativelySecondary outcomes
1
Number of patients showing postoperative wound dehiscence
Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the
Time frame
10 ± 5 days postoperatively2
Number of patients showing postoperative Dentinal hypersensitivity
Incidence of Dentinal hypersensitivity after resective periodontal surgery
Time frame
10 ± 5 days postoperatively3
Number of patients showing postoperative Oral candidiasis
Incidence of oral candidiasis after resective periodontal surgery
Time frame
10 ± 5 days postoperatively4
Number of patients showing postoperative Angular cheilitis
Incidence of Angular cheilitis after resective periodontal surgery
Time frame
10 ± 5 days postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Aesculap AG
Lead sponsor
B.Braun Surgical SA
Collaborator
Source ClinicalTrials.gov