NCT02653924

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 7, 2016

Last Update Submit

January 13, 2016

Conditions

Oral Surgical Procedures

Keywords

Suturebacteria

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

silk suture

ACTIVE COMPARATOR

silk suture

Other: silk suture

vicryl suture

ACTIVE COMPARATOR

vicryl suture

Other: vicryl suture

nylon suture

ACTIVE COMPARATOR

nylon suture

Other: nylon suture

polypropylene suture

ACTIVE COMPARATOR

polypropylene suture

Other: polypropylene suture

Interventions

silk sutureOTHER

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.

Also known as: selection of sutures
silk suture
vicryl sutureOTHER

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.

Also known as: selection of sutures
vicryl suture
nylon sutureOTHER

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.

Also known as: selection of sutures
nylon suture
polypropylene sutureOTHER

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.

Also known as: selection of sutures
polypropylene suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diabetes, heart disease, immune deficiency, thrombocytopenia\\ coagulation enzymes deficiency
  • Chronic alcohol consumption\\ drug user
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1016/j.joms.2006.10.066.

    PMID: 17656275RESULT

  • 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.

    PMID: 10093524RESULT

  • 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.

    PMID: 15329570RESULT

Study Officials

  • Dudu Polak, DMD

    Department of Periodontology, Hadassah Medical Center, Jerusalem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dudu Polak, DMD

CONTACT

+972-2-6778662polak@mail.huji.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 13, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

May 1, 2017

Last Updated

January 14, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share