An interventional study of Novosyn® in resective periodontal surgery and Monosyn® in resective periodontal surgery in Gingivitis, Gingival Diseases and Periodontal Diseases, sponsored by Aesculap AG. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Aesculap AG (part of B. Braun) · Not applicable, Interventional, and Treatment
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 84 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative wound dehiscence
Incidence of wound dehiscence after resective periodontal surgery. Dehiscence is the
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Dentinal hypersensitivity
Incidence of Dentinal hypersensitivity after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Oral candidiasis
Incidence of oral candidiasis after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Angular cheilitis
Incidence of Angular cheilitis after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Swelling
Incidence of Swelling after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Bleeding
Incidence of Bleeding after resective periodontal surgery
Time frame: 10 ± 5 days postoperatively
Number of patients showing postoperative Infection
Incidence of infection after resective periodontal surgery
Time frame: 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.
Time frame: 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"
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: intraoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Nov 2026, 41 months after the start.
Of 53 industry-sponsored interventional studies with no phase under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 5. This study's planned 41 months is above that.
Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
Primary completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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