Clinical trial NCT05813236: NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery
Official title: Randomized, Monocentric, Double Blinded, Prospective Study to Evaluate the Early Wound Healing After the Utilization of NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingivitis
Gingival Diseases
Periodontal Diseases
Keywords: Resective periodontal surgery
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2023-04-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing resective periodontal surgery will randomly (1:1) receive Novosyn Quick (control group) or Monosyn Quick (treatment group).

Randomization will take place intraoperatively through dynamic allocation with minimisation algorithm to a suture group. Randomization will be stratified by study site.
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* Adult patient undergoing resective periodontal surgery abd one of the incisions below has been performed:
* Crestal incision
* Vertical incision
* Intrasulcular incision
* Submarginal incision
* Written informed consent regarding the data collection for the RCT

Exclusion Criteria:

* Emergency surgery.
* Pregnancy.
* Breastfeeding
* Patients taking medication that might affect wound healing.
* Patients having a condition that might affect wound healing.
* Patients with hypersensitivity or allergy to the suture material

Primary outcomes:
measure: early wound healing score (EHS)
timeFrame: 10 ± 5 days postoperatively
Secondary outcomes:
measure: Number of patients showing postoperative wound dehiscence
timeFrame: 10 ± 5 days postoperatively
measure: Number of patients showing postoperative Dentinal hypersensitivity
timeFrame: 10 ± 5 days postoperatively
measure: Number of patients showing postoperative Oral candidiasis
timeFrame: 10 ± 5 days postoperatively
measure: Number of patients showing postoperative Angular cheilitis
timeFrame: 10 ± 5 days postoperatively
measure: Number of patients showing postoperative Swelling
timeFrame: 10 ± 5 days postoperatively
measure: Number of patients showing postoperative Bleeding
timeFrame: 10 ± 5 days postoperatively
measure: Number of patients showing postoperative Infection
timeFrame: 10 ± 5 days postoperatively
measure: Number of Systemic complications
timeFrame: 10 ± 5 days postoperatively
measure: Pain assessment
timeFrame: 10 ± 5 days postoperatively
measure: Satisfaction of the patient
timeFrame: 10 ± 5 days postoperatively
measure: Number of patients with Bacterial contamination of the thread (optional)
timeFrame: 10 ± 5 days postoperatively
measure: Assessment of the handling of the suture material
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Facultat d'Odontologia. Universitat Internacional de Catalunya
state: Catalunya
Study officials:
affiliation: Facultat d'Odontologia. Universitat Internacional de Catalunya
name: Carolina Mor Reinoso, Dra.
role: PRINCIPAL_INVESTIGATOR
References: