GingivitisNOQMOQSNCT05813236
NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery
A study testing Novosyn® in resective periodontal surgery and Monosyn® in resective periodontal surgery in people with Gingivitis and Gingival Diseases, run by Aesculap AG at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis, Gingival Diseases, Periodontal Diseases
- What is being tested?
- Novosyn® in resective periodontal surgery and Monosyn® in resective periodontal surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jun 2023to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jose Manuel Molina, Dr. contact
Spain1 site, 1 recruiting
- Recruiting
Facultat d'Odontologia. Universitat Internacional de Catalunya
Sant Cugat del Vallès, Catalonia, 08195
Carolina Mor Reinoso, Dra.
Carolina Mor Reinoso, Dra.
About this study
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
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.
- Conditions
- Gingivitis, Gingival Diseases, Periodontal Diseases
- Being tested
- Novosyn® in resective periodontal surgery, Monosyn® in resective periodontal surgery
- Keywords
- Resective periodontal surgery
- Medical subject headings
- Gingivitis, Gingival Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novosyn® in resective periodontal surgeryDevice
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 surgeryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Novosyn® | Experimental | 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). Receives: Device: Novosyn® in resective periodontal surgery |
| Monosyn® | Active comparator | 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. Receives: Device: Monosyn® in resective periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 ± 5 days postoperatively
Secondary outcomes (12)
Number of patients showing postoperative wound dehiscence
Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the
Measured: 10 ± 5 days postoperatively
Number of patients showing postoperative Dentinal hypersensitivity
Incidence of Dentinal hypersensitivity after resective periodontal surgery
Measured: 10 ± 5 days postoperatively
Number of patients showing postoperative Oral candidiasis
Incidence of oral candidiasis after resective periodontal surgery
Measured: 10 ± 5 days postoperatively
Number of patients showing postoperative Angular cheilitis
Incidence of Angular cheilitis after resective periodontal surgery
Measured: 10 ± 5 days postoperatively
Number of patients showing postoperative Swelling
Incidence of Swelling after resective periodontal surgery
Measured: 10 ± 5 days postoperatively
Number of patients showing postoperative Bleeding
Incidence of Bleeding after resective periodontal surgery
Measured: 10 ± 5 days postoperatively
Number of patients showing postoperative Infection
Incidence of infection after resective periodontal surgery
Measured: 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.
Measured: 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"
Measured: 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"
Measured: 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.
Measured: 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.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start28 Jun 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Carolina Mor Reinoso, Dra., Principal investigator, Facultat d'Odontologia. Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813236
- Sponsor's protocol ID
- AAG-O-H-2109
- Acronym
- NOQMOQS
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No