NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery

Periodontal Diseases Clinical Trial

— NOQMOQS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813236
• Other study ID #: AAG-O-H-2109
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Aesculap AG
• Contact: Aina Fernández Rodríguez
• Phone: +34935866200
• Email: info[@]bbraun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Diseases
• Gingivitis
• Periodontal Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Facultat d'Odontologia. Universitat Internacional de Catalunya	Sant Cugat Del Vallès	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients showing postoperative wound dehiscence	Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the	10 ± 5 days postoperatively
Secondary	Number of patients showing postoperative Dentinal hypersensitivity	Incidence of Dentinal hypersensitivity after resective periodontal surgery	10 ± 5 days postoperatively
Secondary	Number of patients showing postoperative Oral candidiasis	Incidence of oral candidiasis after resective periodontal surgery	10 ± 5 days postoperatively
Secondary	Number of patients showing postoperative Angular cheilitis	Incidence of Angular cheilitis after resective periodontal surgery	10 ± 5 days postoperatively
Secondary	Number of patients showing postoperative Swelling	Incidence of Swelling after resective periodontal surgery	10 ± 5 days postoperatively
Secondary	Number of patients showing postoperative Bleeding	Incidence of Bleeding after resective periodontal surgery	10 ± 5 days postoperatively
Secondary	Number of patients showing postoperative Infection	Incidence of infection after resective periodontal surgery	10 ± 5 days postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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