NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery (NOQMOQS)

Aesculap

Status: Enrolling

Conditions: Periodontal Diseases; Gingival Diseases; Gingivitis

Treatments: Device: Monosyn® in resective periodontal surgery; Device: Novosyn® in resective periodontal surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT05813236

AAG-O-H-2109

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Novosyn®

Experimental group

Description:

Novosyn® Quick is available in a range of gauge sizes and lengths, non-needled or attached to stainless steel needles of varying types and sizes: Novosyn® Quick sutures are available undyed in sizes USP 2 (5 metric) through USP 6-0 (0.7 metric).

Treatment:

Device: Novosyn® in resective periodontal surgery

Monosyn®

Active Comparator group

Description:

Monosyn® Quick is a sterile, synthetic, absorbable, monofilament surgical suture material made from a triblock copolymer comprising glycolide (72 %), ε-caprolactone (14 %) and trimethylene carbonate (14 %), which is only available undyed.

Treatment:

Device: Monosyn® in resective periodontal surgery