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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases; Gingivitis; Gingival Diseases
• Intervention / Treatment: Device: Novosyn® in resective periodontal surgery; Device: Monosyn® in resective periodontal surgery

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaume García López, Dr.; Phone Number: +3493586620; Email: info@bbraun.com
• Study Contact Backup: Name: Jose Manuel Molina, Dr.; Email: info@bbraun.com

Study Locations

• Spain
  • Catalonia
    • Sant Cugat del Vallès, Catalonia, Spain, 08195
      • Recruiting
      • Facultat d'Odontologia. Universitat Internacional de Catalunya
      • Contact: Carolina Mor Reinoso, Dra.
      • Principal Investigator: Carolina Mor Reinoso, Dra.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novosyn®; 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).	Device: Novosyn® in resective periodontal surgery; The 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.
Active Comparator: Monosyn®; 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.	Device: Monosyn® in resective periodontal surgery; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 ± 5 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain"	10 ± 5 days postoperatively
Satisfaction of the patient	This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "not satisfied at all" and "100" at the opposite end representing "completely satisfied"	10 ± 5 days postoperatively
Assessment of the handling of the suture material	Assessment of the suture material will be performed intra-operatively using a questionnaire including different dimensions (ease of passage through the tissue, first throw knot holding, knot security, knot tie down smoothness, surgical hand, memory effect and degree of fraying) with 5 point scale (excellent, very good, good, satisfied, poor) and the overall handling of the suture material.	intraoperatively
Number of patients showing postoperative wound dehiscence	Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the	10 ± 5 days postoperatively
Number of patients showing postoperative Dentinal hypersensitivity	Incidence of Dentinal hypersensitivity after resective periodontal surgery	10 ± 5 days postoperatively
Number of patients showing postoperative Oral candidiasis	Incidence of oral candidiasis after resective periodontal surgery	10 ± 5 days postoperatively
Number of patients showing postoperative Angular cheilitis	Incidence of Angular cheilitis after resective periodontal surgery	10 ± 5 days postoperatively
Number of patients showing postoperative Swelling	Incidence of Swelling after resective periodontal surgery	10 ± 5 days postoperatively
Number of patients showing postoperative Bleeding	Incidence of Bleeding after resective periodontal surgery	10 ± 5 days postoperatively
Number of patients showing postoperative Infection	Incidence of infection after resective periodontal surgery	10 ± 5 days postoperatively
Number of Systemic complications	The number of systemic complications is summarized, this includes fever, skin rash, neuropraxia, trismus, osteomyelitis, sinusitis and other complications.	10 ± 5 days postoperatively
Number of patients with Bacterial contamination of the thread (optional)	Assessment of bacterial colonization on the thread of the suture will be evaluated by sending the swab of the suture to laboratory to be investigated and analysed. Polymerase Chain Reaktion Test (PCR) analysis is the test used for bacterial colonization. The micro-IDent® and micro-IDent® plus tests are able to identify 11 bacterial pathogens, including two complex pathogens.	10 ± 5 days postoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Carolina Mor Reinoso, Dra., Facultat d'Odontologia. Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Resective periodontal surgery
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Infections; Periodontal Diseases; Gingivitis; Gingival Diseases
• Other Study ID Numbers: AAG-O-H-2109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No