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

Plain Language Summary

Simplified for easier understanding

This study compares two absorbable suture materials — NOVOSYN Quick and MONOSYN Quick — used to close surgical wounds during resective periodontal surgery (gum surgery that removes diseased gum tissue and reshapes the bone and gum contour around teeth). Both sutures are designed to dissolve on their own over time, but they differ in their composition, handling characteristics, and dissolution timelines. Choosing the right suture can affect how quickly and comfortably the wound heals, how much inflammation occurs, and how often patients need to return for suture removal. Adult patients undergoing resective periodontal surgery who are having one of the standard types of incisions (crestal, vertical, intrasulcular, or submarginal) performed and who have provided written informed consent for data collection are eligible. People undergoing emergency surgery, who are pregnant or breastfeeding, who take medications or have conditions that affect wound healing, or who are allergic to suture materials are excluded. Participants will be randomly assigned to have their surgical wounds closed with one of the two suture types and followed for wound healing outcomes, including inflammation, wound closure, and patient comfort. This research is valuable because periodontal surgery is performed routinely in dental practices worldwide, and a clear evidence base comparing suture options can help surgeons standardize their approach and optimize patient outcomes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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