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
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
April 14, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 6, 2026
March 1, 2026
2.9 years
April 3, 2023
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Number of patients showing postoperative wound dehiscence
10 ± 5 days postoperatively
Number of patients showing postoperative Dentinal hypersensitivity
10 ± 5 days postoperatively
Number of patients showing postoperative Oral candidiasis
10 ± 5 days postoperatively
Number of patients showing postoperative Angular cheilitis
10 ± 5 days postoperatively
Number of patients showing postoperative Swelling
10 ± 5 days postoperatively
- +7 more secondary outcomes
Study Arms (2)
Novosyn®
EXPERIMENTALNovosyn® 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®
ACTIVE COMPARATORMonosyn® 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
- B.Braun Surgical SAcollaborator
Study Sites (1)
Facultat d'Odontologia. Universitat Internacional de Catalunya
Sant Cugat del Vallès, Catalonia, 08195, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolina Mor Reinoso, Dra.
Facultat d'Odontologia. Universitat Internacional de Catalunya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2023
First Posted
April 14, 2023
Study Start
June 28, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share