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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gingivitis, Gingival Diseases, Periodontal Diseases

Intervention / Treatment
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* Device: Novosyn® in resective periodontal surgery
* Device: Monosyn® in resective periodontal surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novosyn®<br>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<br>* 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.<br>|
| Active Comparator: Monosyn®<br>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<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resective periodontal surgery