Oral Surgical ProceduresNCT02653924
The Comparison of Microbial Adherence to Various Sutures in Patients Undergoing Oral Surgery
A study testing silk suture, vicryl suture and nylon suture in people with Oral Surgical Procedures, run by Hadassah Medical Organization.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Surgical Procedures
- What is being tested?
- silk suture, vicryl suture and nylon suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes, heart disease, immune deficiency, thrombocytopenia\ coagulation enzymes deficiency
- Chronic alcohol consumption\ drug user
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Oral Surgical Procedures
- Being tested
- silk suture, vicryl suture, nylon suture, polypropylene suture
- Keywords
- Suture, bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silk sutureOther
Also called selection of sutures
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 sutureOther
Also called selection of sutures
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 sutureOther
Also called selection of sutures
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 sutureOther
Also called selection of sutures
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.
| Study group | Role | What they receive |
|---|---|---|
| silk suture | Active comparator | silk suture Receives: Other: silk suture |
| vicryl suture | Active comparator | vicryl suture Receives: Other: vicryl suture |
| nylon suture | Active comparator | nylon suture Receives: Other: nylon suture |
| polypropylene suture | Active comparator | polypropylene suture Receives: Other: polypropylene suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcome measure will be assessed 10 days after sample incubation for the different sutures obtained from each study participate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dudu Polak, DMD, Principal investigator, Department of Periodontology, Hadassah Medical Center, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653924
- Sponsor's protocol ID
- HadassahMC
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17656275Selvig KA, Biagiotti GR, Leknes KN, Wikesjo UM. Oral tissue reactions to suture materials. Int J Periodontics Restorative Dent. 1998 Oct;18(5):474-87.
PubMed 10093524Grigg 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.
PubMed 15329570
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Microbial Adherence to Various Sutures in Patients Undergoing Oral Surgery
- ClinicalTrials.gov ID
- NCT02653924
- Acronym / sponsor ID
- HadassahMC
- Conditions
- Oral Surgical Procedures
- Keywords
- Suture, bacteria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| silk suture | Active comparator | Other: silk suturesilk suture |
| vicryl suture | Active comparator | Other: vicryl suturevicryl suture |
| nylon suture | Active comparator | Other: nylon suturenylon suture |
| polypropylene suture | Active comparator | Other: polypropylene suturepolypropylene suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Diabetes, heart disease, immune deficiency, thrombocytopenia\ coagulation enzymes deficiency
- Chronic alcohol consumption\ drug user
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silk sutureAlso: selection of sutureseach 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. | Other | silk suture |
| vicryl sutureAlso: selection of sutureseach 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. | Other | vicryl suture |
| nylon sutureAlso: selection of sutureseach 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. | Other | nylon suture |
| polypropylene sutureAlso: selection of sutureseach 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. | Other | polypropylene suture |
Primary outcome
bacterial counts on blood agar plates from each suture will be quantified in CFU (colony-forming units) and expressed as total bacteria/suture
Time frame: Outcome measure will be assessed 10 days after sample incubation for the different sutures obtained from each study participate
CFU from all four different sutures (silk, vicryl, nylon and polypropylene sutures) will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Results publication: PubMed 17656275Banche 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.
- Results publication: PubMed 10093524Selvig KA, Biagiotti GR, Leknes KN, Wikesjo UM. Oral tissue reactions to suture materials. Int J Periodontics Restorative Dent. 1998 Oct;18(5):474-87.
- Results publication: PubMed 15329570Grigg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dudu Polak, DMD principal investigator
Department of Periodontology, Hadassah Medical Center, Jerusalem
Questions about this trial
What is this clinical trial studying?
A study testing silk suture, vicryl suture and nylon suture in people with Oral Surgical Procedures, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dudu Polak, DMD (+972-2-6778662, polak@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial counts on blood agar plates from each suture will be quantified in CFU (colony-forming units) and expressed as total bacteria/suture (time frame: Outcome measure will be assessed 10 days after sample incubation for the different sutures obtained from each study participate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653924, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.