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Recruiting NCT05813236

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

No phase Interventional Gingivitis Gingival Diseases Periodontal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Novosyn® in resective periodontal surgery, Monosyn® in resective periodontal surgery.
Who it may be relevant to
Registry conditions: Gingivitis, Gingival Diseases, Periodontal Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • early wound healing score (EHS) [Time frame: 10 ± 5 days postoperatively]
Secondary outcome measures (12)
  • Number of patients showing postoperative wound dehiscence [Time frame: 10 ± 5 days postoperatively]
  • Number of patients showing postoperative Dentinal hypersensitivity [Time frame: 10 ± 5 days postoperatively]
  • Number of patients showing postoperative Oral candidiasis [Time frame: 10 ± 5 days postoperatively]
  • Number of patients showing postoperative Angular cheilitis [Time frame: 10 ± 5 days postoperatively]
  • Number of patients showing postoperative Swelling [Time frame: 10 ± 5 days postoperatively]
  • Number of patients showing postoperative Bleeding [Time frame: 10 ± 5 days postoperatively]
  • Number of patients showing postoperative Infection [Time frame: 10 ± 5 days postoperatively]
  • Number of Systemic complications [Time frame: 10 ± 5 days postoperatively]
  • Pain assessment [Time frame: 10 ± 5 days postoperatively]
  • Satisfaction of the patient [Time frame: 10 ± 5 days postoperatively]
  • Number of patients with Bacterial contamination of the thread (optional) [Time frame: 10 ± 5 days postoperatively]
  • Assessment of the handling of the suture material [Time frame: intraoperatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Facultat d'Odontologia. Universitat Internacional de Catalunya — Sant Cugat del Vallès

Identifiers

NCT: NCT05813236 · AAG-O-H-2109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗