Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05813236

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultat d'Odontologia. Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, 08195, Spain

Location status: Recruiting

Location contact

Carolina Mor Reinoso, Dra.

CONTACT

Carolina Mor Reinoso, Dra.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novosyn® in resective periodontal surgery

Device

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.

Monosyn® in resective periodontal surgery

Device

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 outcomes

  1. early wound healing score (EHS)

    Time frame: 10 ± 5 days postoperatively

    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 outcomes

  1. Number of patients showing postoperative wound dehiscence

    Time frame: 10 ± 5 days postoperatively

    Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the

  2. Number of patients showing postoperative Dentinal hypersensitivity

    Time frame: 10 ± 5 days postoperatively

    Incidence of Dentinal hypersensitivity after resective periodontal surgery

  3. Number of patients showing postoperative Oral candidiasis

    Time frame: 10 ± 5 days postoperatively

    Incidence of oral candidiasis after resective periodontal surgery

  4. Number of patients showing postoperative Angular cheilitis

    Time frame: 10 ± 5 days postoperatively

    Incidence of Angular cheilitis after resective periodontal surgery

  5. Number of patients showing postoperative Swelling

    Time frame: 10 ± 5 days postoperatively

    Incidence of Swelling after resective periodontal surgery

  6. Number of patients showing postoperative Bleeding

    Time frame: 10 ± 5 days postoperatively

    Incidence of Bleeding after resective periodontal surgery

  7. Number of patients showing postoperative Infection

    Time frame: 10 ± 5 days postoperatively

    Incidence of infection after resective periodontal surgery

  8. Number of Systemic complications

    Time frame: 10 ± 5 days postoperatively

    The number of systemic complications is summarized, this includes fever, skin rash, neuropraxia, trismus, osteomyelitis, sinusitis and other complications.

  9. Pain assessment

    Time frame: 10 ± 5 days postoperatively

    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. Satisfaction of the patient

    Time frame: 10 ± 5 days postoperatively

    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"

  11. Number of patients with Bacterial contamination of the thread (optional)

    Time frame: 10 ± 5 days postoperatively

    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.

  12. Assessment of the handling of the suture material

    Time frame: intraoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jaume García López, Dr.

CONTACT

[email protected]

+3493586620

Jose Manuel Molina, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study 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

Acronym: NOQMOQS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.