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

NCT ID: NCT02653924

Last Updated: 2016-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Oral Surgical Procedures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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silk suture

silk suture

Group Type ACTIVE_COMPARATOR

silk suture

Intervention Type OTHER

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

vicryl suture

Group Type ACTIVE_COMPARATOR

vicryl suture

Intervention Type OTHER

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

nylon suture

Group Type ACTIVE_COMPARATOR

nylon suture

Intervention Type OTHER

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

polypropylene suture

Group Type ACTIVE_COMPARATOR

polypropylene suture

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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selection of sutures selection of sutures selection of sutures selection of sutures

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dudu Polak, DMD

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontology, Hadassah Medical Center, Jerusalem

Central Contacts

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Dudu Polak, DMD

Role: CONTACT

+972-2-6778662

References

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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. doi: 10.1016/j.joms.2006.10.066.

Reference Type RESULT
PMID: 17656275 (View on PubMed)

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

Reference Type RESULT
PMID: 10093524 (View on PubMed)

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. doi: 10.1097/01.don.0000121617.67923.05.

Reference Type RESULT
PMID: 15329570 (View on PubMed)

Other Identifiers

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HadassahMC

Identifier Type: -

Identifier Source: org_study_id

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