- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07498361
Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial.
This study aims to compare slow-resorbing and fast-resorbing sutures used after the surgical extraction of lower third molars. Sutures are routinely placed after wisdom tooth removal to promote hemostasis. Slow-resorbing and fast-resorbing sutures differ mainly in how long they remain in place, and fast-resorbing sutures often do not require removal. The study evaluates whether these two types of sutures differ in terms of microbiological contamination. Patient-reported inflammation, swelling, and postoperative discomfort will also be assessed.
Each participant will be randomly assigned to receive one of the two suture types. Only routine clinical procedures are involved. Participation includes several standard visits: initial medical and dental history collection with oral and radiographic examination; the surgical extraction of the lower third molar; suture removal at 7 days. No additional invasive procedures are required.
Participants will receive a daily diary to record pain levels and any pain medication taken during the first postoperative week. At the 7-day visit, wound healing will be evaluated and sutures will be removed, collected and anonymously analyzed by the University Microbiology Laboratory.
This study seeks to provide useful information about the clinical performance and microbiological behavior of different types of resorbable sutures commonly used in oral surgery, with the goal of improving patient care and postoperative outcomes.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study investigates the use of slow-resorbing versus fast-resorbing sutures following the surgical extraction of lower third molars. Sutures are routinely placed after wisdom tooth removal to promote hemostasis. Fast-resorbing sutures often do not require removal, while slow-resorbing sutures typically remain in place longer. The aim of the study is to compare the two types of sutures in terms of microbiological contamination. Patient-reported inflammation, swelling, and overall discomfort will also be assessed.
Each participant will be randomly assigned to receive one of the two suture types. Only routine oral surgery procedures are included, and no additional invasive or non-routine interventions are planned. Participation involves several standard visits: an initial screening visit with medical and dental history collection, oral examination, plaque and bleeding assessment, and radiographic review; the surgical extraction of the lower third molar; suture removal after 7 days.
On the day of the procedure, participants will receive a daily questionnaire to record pain levels and any analgesic medication taken during the first postoperative week. After surgery, standard antibiotic and anti-inflammatory therapy will be prescribed.
At the 7-day visit, sutures will be removed. The removed sutures will be collected and anonymously sent to the University Microbiology Laboratory (UniPD) for analysis and the participant's questionnaire will be retrieved.
Participants are expected to follow all postoperative instructions and attend all scheduled visits, which are essential both for proper clinical follow-up and for participation in the study. Any complications such as pain or bleeding must be promptly reported to the dentist. The overall goal of the study is to better understand the clinical and microbiological behavior of commonly used resorbable sutures in oral surgery, ultimately aiming to improve patient care and postoperative outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefano Sivolella, DDS
- Phone Number: 049 821 8669
- Email: stefano.sivolella@unipd.it
Study Locations
-
-
Padua
-
Padua, Padua, Italy, 35100
- Recruiting
- Hospital Dental Clinic
-
Contact:
- Hospital Dental Clinic
- Phone Number: 049 8218669
- Email: odontoiatria@aopd.veneto.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- non smoker patients
- clinical indication to third molar surgical removal
- patients who are able to express informed consent
Exclusion Criteria:
- smokers
- pregnant female
- subjects treated with medications that affect bone metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Polysorb group
Standard absorbable sutures will be applied on these patients.
|
Standard absorbable sutures application will be applied on control group
|
|
Experimental: Velosorb group
Fast absorbable sutures will be applied on these patients
|
Fast absorbable sutures application on experimental group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiological evaluation of the sutures
Time Frame: Evaluation will be conducted at the removal of the sutures (7 days after surgery)
|
After seven days, one operator will remove the sutures and immediately place them in a sterile, pre-weighed tube containing 1 ml of Brain Heart Infusion broth (BHI, Thermo Fisher, Waltham, USA), avoiding external contamination.
Samples will be immediately transported to the microbiology laboratory, weighed, vortexed, and seeded on blood agar (BA), anaerobe blood agar (CDC), chocolate agar (CA), and Mitis salivarius agar (MSA), under anaerobic and aerobic conditions at 37°C for 24 hours.
The bacterial load will be quantified as colony-forming units per millilitre (CFU/ml) and normalised by the weight of the sample.
|
Evaluation will be conducted at the removal of the sutures (7 days after surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician evaluation
Time Frame: Clinical evaluation will be collected at the removal of the sutures (7 days after surgery)
|
From the clinician's perspective, they will be required to report, on a VAS scale, the level of difficulty encountered during suture removal at 7 days post-surgery, which will be performed using sterile scissors and forceps.
The Visual Analog Scale (VAS) is used with values ranging from 1 to 10, where 1 corresponds to the minimum value (minimal difficulty for the operator) and 10 corresponds to the maximum value (maximum difficulty for the operator), with 2-9 representing intermediate values.
|
Clinical evaluation will be collected at the removal of the sutures (7 days after surgery)
|
|
Patient reported outcomes
Time Frame: These parameters will be collected 7 days after surgery (at sutures removal)
|
From the patient's perspective, a VAS (Visual Analogue Scale) will be used to subjectively assess the discomfort during the 7 days in which the sutures remain in the mouth, as well as the pain associated with their removal after 7 days.
The Visual Analog Scale (VAS) is used with values ranging from 1 to 10, where 1 corresponds to the minimum value (minimal discomfort for the patient) and 10 corresponds to the maximum value (maximum discomfort for the patient), with 2-9 representing intermediate values.
|
These parameters will be collected 7 days after surgery (at sutures removal)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- R. Asher, T. Chacartchi, M. Tandlich, L. Shapira, and D. Polak, "Microbial accumulation on different suture materials following oral surgery: a randomized controlled study.," Clin. Oral Investig., vol. 23, no. 2, pp. 559-565, Feb. 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AOP3206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Third Molar Surgery
-
Postgraduate Institute of Dental Sciences RohtakCompletedImpacted Third Molar Tooth | Third Molar Extraction Surgery | Third Molar Extraction | Impacted Third MolarIndia
-
Huashan HospitalNot yet recruitingMolar, Third | Photobiomodulation | Third Molar Surgery | Photobiomodulation TherapyChina
-
Bahçeşehir UniversityCompletedThird Molar Extraction Surgery | Third Molar Impaction | Satisfaction SurveyTurkey (Türkiye)
-
Ataturk UniversityCompletedPost Operative Analgesia | Third Molar SurgeryTurkey (Türkiye)
-
University Hospital, Strasbourg, FranceNot yet recruitingDental Anxiety | Oral Surgery | Third Molar Extraction
-
Recep Tayyip Erdogan UniversityRecruitingOral Surgery | Postoperative Morbidity | Impacted Mandibular Third MolarTurkey (Türkiye)
-
University of CataniaCompletedImpacted Third Molar Tooth | Third Molar SurgeryItaly
-
Universidad Católica San Antonio de MurciaCompletedHealthy | Antibiotic Prophylaxis | Third Molar Extraction Surgery | AmoxicillinSpain
-
Services Institute of Medical Sciences, PakistanNot yet recruitingThird Molar SurgeryPakistan
-
AB Biotics, SAHospital de Nens de BarcelonaCompletedSurgery--Complications | Molar, ThirdSpain
Clinical Trials on Standard absorbable sutures application
-
University of Texas at AustinCompletedGanglion Cysts | Carpal Tunnel Syndrome | Trigger Finger | Dupuytren Contracture | All Minor Hand Surgery Including | De Quervain SyndromeUnited States
-
University of Missouri-ColumbiaRecruitingHip Arthroscopy | Femoroacetabular Impingement Syndrome | Labrum Injury of the Hip JointUnited States
-
Medtronic - MITGCompletedSkin Laxity of Abdomen, Thighs, Chest, Back, and NeckUnited States
-
Medtronic - MITGTerminatedPerineal Laceration RepairUnited States
-
London School of Hygiene and Tropical MedicineCompletedTrachoma | Trachomatous TrichiasisEthiopia
-
Johns Hopkins UniversityTerminated
-
Cody BlanchardCompletedSurgical Wound | Brow PtosisUnited States
-
Tufts Medical CenterCompleted
-
Temple UniversityCompletedLacerations | WoundsUnited States
-
University of British ColumbiaUnknown