RecruitingNot ApplicableNCT05813236

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

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


Sponsor

Aesculap AG

Enrollment

84 participants

Start Date

Jun 28, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

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Interventions

DEVICENovosyn® 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.

DEVICEMonosyn® 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(1)

Facultat d'Odontologia. Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, Spain

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NCT05813236


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