search
Back to results

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

Primary Purpose

Gingivitis, Gingival Diseases, Periodontal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Novosyn® in resective periodontal surgery
Monosyn® in resective periodontal surgery
Sponsored by
Aesculap AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Resective periodontal surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Facultat d'Odontologia. Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novosyn®

Monosyn®

Arm 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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients showing postoperative wound dehiscence
Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the
Number of patients showing postoperative Dentinal hypersensitivity
Incidence of Dentinal hypersensitivity after resective periodontal surgery
Number of patients showing postoperative Oral candidiasis
Incidence of oral candidiasis after resective periodontal surgery
Number of patients showing postoperative Angular cheilitis
Incidence of Angular cheilitis after resective periodontal surgery
Number of patients showing postoperative Swelling
Incidence of Swelling after resective periodontal surgery
Number of patients showing postoperative Bleeding
Incidence of Bleeding after resective periodontal surgery
Number of patients showing postoperative Infection
Incidence of infection after resective periodontal surgery
Number of Systemic complications
The number of systemic complications is summarized, this includes fever, skin rash, neuropraxia, trismus, osteomyelitis, sinusitis and other complications.
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"
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"
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.
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.

Full Information

First Posted
April 3, 2023
Last Updated
July 28, 2023
Sponsor
Aesculap AG
Collaborators
B.Braun Surgical SA
search

1. Study Identification

Unique Protocol Identification Number
NCT05813236
Brief Title
NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG
Collaborators
B.Braun Surgical SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Gingival Diseases, Periodontal Diseases
Keywords
Resective periodontal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients and the observers (assessors) will be blinded to the applied suture material. Patients will not be informed which suture material will be applied. The observers (assessors) who will perform the assessment of the wounds will also be unaware of the applied suture type.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novosyn®
Arm Type
Experimental
Arm 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).
Arm Title
Monosyn®
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Novosyn® in resective periodontal surgery
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Monosyn® in resective periodontal surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
early wound healing score (EHS)
Description
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 postoperatively
Secondary Outcome Measure Information:
Title
Number of patients showing postoperative wound dehiscence
Description
Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the
Time Frame
10 ± 5 days postoperatively
Title
Number of patients showing postoperative Dentinal hypersensitivity
Description
Incidence of Dentinal hypersensitivity after resective periodontal surgery
Time Frame
10 ± 5 days postoperatively
Title
Number of patients showing postoperative Oral candidiasis
Description
Incidence of oral candidiasis after resective periodontal surgery
Time Frame
10 ± 5 days postoperatively
Title
Number of patients showing postoperative Angular cheilitis
Description
Incidence of Angular cheilitis after resective periodontal surgery
Time Frame
10 ± 5 days postoperatively
Title
Number of patients showing postoperative Swelling
Description
Incidence of Swelling after resective periodontal surgery
Time Frame
10 ± 5 days postoperatively
Title
Number of patients showing postoperative Bleeding
Description
Incidence of Bleeding after resective periodontal surgery
Time Frame
10 ± 5 days postoperatively
Title
Number of patients showing postoperative Infection
Description
Incidence of infection after resective periodontal surgery
Time Frame
10 ± 5 days postoperatively
Title
Number of Systemic complications
Description
The number of systemic complications is summarized, this includes fever, skin rash, neuropraxia, trismus, osteomyelitis, sinusitis and other complications.
Time Frame
10 ± 5 days postoperatively
Title
Pain assessment
Description
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"
Time Frame
10 ± 5 days postoperatively
Title
Satisfaction of the patient
Description
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"
Time Frame
10 ± 5 days postoperatively
Title
Number of patients with Bacterial contamination of the thread (optional)
Description
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.
Time Frame
10 ± 5 days postoperatively
Title
Assessment of the handling of the suture material
Description
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.
Time Frame
intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aina Fernández Rodríguez
Phone
+34935866200
Email
info@bbraun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ricard Rosique
Email
info@bbraun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Mor Reinoso, Dra.
Organizational Affiliation
Facultat d'Odontologia. Universitat Internacional de Catalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultat d'Odontologia. Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Catalunya
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Mor Reinoso, Dra.
First Name & Middle Initial & Last Name & Degree
Carolina Mor Reinoso, Dra.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs