The Comparison of Microbial Adherence to Various Sutures in Patients Undergoing Oral Surgery

Oral Surgical Procedures Clinical Trial

Official title:

The Comparison of Microbial Adherence to Various Sutures in Patients Undergoing Oral Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02653924
• Other study ID #: HadassahMC
• Status: Not yet recruiting
• Phase: N/A
• First received: January 7, 2016
• Last updated: January 13, 2016
• Start date: January 2016
• Est. completion date: May 2017

Study information

• Verified date: January 2016
• Source: Hadassah Medical Organization
• Contact: Dudu Polak, DMD
• Phone: +972-2-6778662
• Email: polak[@]mail.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The final stage of any surgical procedure is suturing. Sutures have a vital rule in wound healing- they are responsible for flaps approximation, hemostasis and restoring function and esthetics.

Choosing the right suture is crucial especially in oral sites because of its unique anatomical features: the presence of saliva and the patient's everyday function- swallowing, talking, eating etc.

Sutures require certain physical properties such as tensile strength, dimensional stability, lack of memory, knot security and elasticity. One highly important quality is the ability to prevent or reduce bacterial adhesion and by that to prevent secondary infection. There are many kinds of sutures in the market- none of which contains all the ideal features.

The aim of the study is to compare the amount of bacterial adhesion to different kinds of sutures in patients undergoing periodontal surgery.

Description:

The participates in the study are scheduled to go oral surgery: dental implantation, Guided bone regeneration, resective periodontal surgery, sinus elevation (both crestal or lateral).

All participates will sign an informed consent form and under the institutional ethics committee approval will go to through the operation.

Each surgery will include at least 4 Simple Interrupted Suture with even spacing of 5 mm from each other in the scheduled for operation and without changing the original treatment plan. Incision location is in the area of surgery and not in a distinct location. The four sutures that will be used are: silk, vicryl, nylon and polypropylene.

At suture removal, after 10 days, all sutures will be collected in a sterile tube containing PBS solution. Within 3 hours, the samples will be sowed on two blood agar media plates. One plate will be aerobic condition and the other in an-aerobic condition. After one week, the number of colonies will use to calculate the CFU- colony-forming units.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients designated for oral surgery with the possibility to perform at least 4 sutures, 5mm apart. The surgery will take place at the periodontology department, Dental faculty, Hadassah medical center.

• Patients willing to participate in the study and sign an informed concerned form

• Patients without systemic illness

Exclusion Criteria:

• Diabetes, heart disease, immune deficiency, thrombocytopenia\ coagulation enzymes deficiency

• Chronic alcohol consumption\ drug user

• Pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Surgical Procedures

Intervention

Other:
• silk suture
each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
• vicryl suture
each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
• nylon suture
each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
• polypropylene suture
each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

References & Publications (3)

Banche G, Roana J, Mandras N, Amasio M, Gallesio C, Allizond V, Angeretti A, Tullio V, Cuffini AM. Microbial adherence on various intraoral suture materials in patients undergoing dental surgery. J Oral Maxillofac Surg. 2007 Aug;65(8):1503-7. — View Citation

Grigg TR, Liewehr FR, Patton WR, Buxton TB, McPherson JC. Effect of the wicking behavior of multifilament sutures. J Endod. 2004 Sep;30(9):649-52. — View Citation

Selvig KA, Biagiotti GR, Leknes KN, Wikesjö UM. Oral tissue reactions to suture materials. Int J Periodontics Restorative Dent. 1998 Oct;18(5):474-87. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial counts on blood agar plates from each suture will be quantified in CFU (colony-forming units) and expressed as total bacteria/suture	CFU from all four different sutures (silk, vicryl, nylon and polypropylene sutures) will be compared.	Outcome measure will be assessed 10 days after sample incubation for the different sutures obtained from each study participate	No