Suture Adverse ReactionNCT04234308
Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery
A study testing Polyglycolic Acid, Catgut and Polytetrafluoroethylene in people with Suture Adverse Reaction and Suture; Complications, Mechanical, run by Universidad Científica del Sur.
Trial summary
A suture is a biomedical device that is made of natural or synthetic materials. Sutures are used to close tissue surfaces until wounds heal and regain their ability to withstand normal stresses. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suture Adverse Reaction, Suture; Complications, Mechanical, Suture Failure During Surgical Operation
- What is being tested?
- Polyglycolic Acid, Catgut and Polytetrafluoroethylene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Mar 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must have read, understood and signed the informed consent form. Subject must require either open flap debridement surgery or implant placement (one to three consecutive teeth replacement) surgery.
- Subjects must be males or females who are a minimum of 20 years of age. No history of periodontal or implant surgery at the investigational area site within the past 12 months.
- Periodontal probing depths ≥5 mm interdentally at the implant site. Subjects that received single interrupted sutures for flap closure following surgical procedures.
Who cannot join
- Subject is part of a vulnerable population will be excluded. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
- Subjects with a systemic disease that would preclude periodontal surgery. Subjects who are smokers or chew tobacco. Subjects that received periodontal dressing on the surgical area. Subjects with the presence of acute infectious lesions in the areas intended for surgery.
- Subjects with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical, Mechanical, and Histological Properties of Absorbable and Nonabsorbable Suture Materials Used in Periodontal and Dental Implant Surgery.
A suture is a biomedical device that is made of natural or synthetic materials. Sutures are used to close tissue surfaces until wounds heal and regain their ability to withstand normal stresses. Although different suture materials are available for various dental procedures, clinicians commonly neglect to select sutures based on their mechanical properties and capabilities. Instead, clinicians rely on their clinical experience to determine which suture material will suffice for wound closure and healing. To our knowledge, there have been no published studies detailing the results of mechanical testing on sutures after clinical application. The aim of this study is to clinically, histologically, and mechanically assess the four common sutures used in periodontal and dental surgery, with the hopes of providing clinicians with a guide that will allow them to choose sutures based on the clinical, histological, mechanical properties that best fit the stress and strain applied to the wound.
- Conditions
- Suture Adverse Reaction, Suture; Complications, Mechanical, Suture Failure During Surgical Operation, Suture Related Complication, Suture Rupture, Suture; Complications, Infection or Inflammation
- Being tested
- Polyglycolic Acid, Catgut, Polytetrafluoroethylene, Polyamide
- Keywords
- dental suture, suture infection, Mechanical properties, absorbable sutures, non-absorbable sutures, histological properties
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglycolic AcidDrug
Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).
CatgutDrug
Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)
PolytetrafluoroethyleneDrug
Also called ePTFE
Periodontal and periimplant flaps closed with at least one suture with expanded Polytetrafluoroethylene Non absorbable suture, synthetic, 4-0. (TAGUM®)
PolyamideDrug
Also called Nylon
Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)
| Study group | Role | What they receive |
|---|---|---|
| Polyglycolic Acid Absorbable suture | Experimental | Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®). Receives: Drug: Polyglycolic Acid |
| Chromic Gut Absorbable suture | Experimental | Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®) Receives: Drug: Catgut |
| ePTFE Non absorbable suture | Experimental | Periodontal and periimplant flaps closed with at least one suture with ePTFE Non absorbable suture, synthetic, 4-0. (TAGUM®) Receives: Drug: Polytetrafluoroethylene |
| Nylon Non absorbable sutures | Experimental | Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®) Receives: Drug: Polyamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing changes around each suture material
To determinate the healing changes around each suture material using the Healing Index of Landry and colleagues (1988)
Measured: 1 week, 2 weeks 1 month and 3 months after surgery.
Tensile and mechanical properties of each suture material
Evaluation of the tensile mechanical properties of each suture material using a Chatilloin TCD200 jig attachment, and tensile load will be applied to each suture at 0.05N/mm per min. Each suture will be stretched to failure and the maximum load will be recorded in Newtons (N).
Measured: following 1 week of clinical application.
Biofilm formation around each suture material
To determinate the biofilm formation around each suture material using PCR
Measured: following 1 week of clinical application.
Secondary outcomes (3)
complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue
To determinate the presence of complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue
Measured: 1 week, 2 weeks, 1 month and 3 months after surgery.
plaque adherence over sutures, number of sutures present and number of stable (untied) sutures
To determinate the plaque adherence over sutures, number of sutures present and number of stable (untied) sutures
- Plaque adherence over sutures. This will be classified as following: 0: no debris or plaque present;
- soft debris or plaque covering not more than one third of the sutures,
- soft debris or plaque covering more than one third of the exposed suture;
- soft debris of plaque covering more than two thirds of the exposed sutures.
Measured: 1 week after surgery.
subject satisfaction
To determinate subject pain/satisfaction using a Visual Analogue Scale (VAS) at Visits 2 and 5. The VAS will be given to the subject in order to rate the satisfaction on a scale from 0 to 10, where 10 is the highest level of pain/satisfaction.
Measured: 1 week and 3 months following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture Adverse ReactionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Científica del Sur
- Sponsor type
- University, hospital or other
- Collaborators
- New York University
- Responsible party
- Sponsor
- Investigators
- Ismael Khouly, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234308
- Sponsor's protocol ID
- 010-2019-PRO8
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Mechanical, and Histological Properties of Absorbable and Nonabsorbable Suture Materials Used in Periodontal and Dental Implant Surgery.
- ClinicalTrials.gov ID
- NCT04234308
- Acronym / sponsor ID
- 010-2019-PRO8
- Conditions
- Suture Adverse Reaction, Suture; Complications, Mechanical, Suture Failure During Surgical Operation, Suture Related Complication, Suture Rupture, Suture; Complications, Infection or Inflammation
- Keywords
- dental suture, suture infection, Mechanical properties, absorbable sutures, non-absorbable sutures, histological properties
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidad Científica del SurUniversity, hospital or other
- Collaborators
- New York University
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 21 Jan 2020 (actual)
- 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.
A suture is a biomedical device that is made of natural or synthetic materials. Sutures are used to close tissue surfaces until wounds heal and regain their ability to withstand normal stresses. Although different suture materials are available for various dental procedures, clinicians commonly neglect to select sutures based on their mechanical properties and capabilities. Instead, clinicians rely on their clinical experience to determine which suture material will suffice for wound closure and healing. To our knowledge, there have been no published studies detailing the results of mechanical testing on sutures after clinical application. The aim of this study is to clinically, histologically, and mechanically assess the four common sutures used in periodontal and dental surgery, with the hopes of providing clinicians with a guide that will allow them to choose sutures based on the clinical, histological, mechanical properties that best fit the stress and strain applied to the wound.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polyglycolic Acid Absorbable suture | Experimental | Drug: Polyglycolic AcidPeriodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®). |
| Chromic Gut Absorbable suture | Experimental | Drug: CatgutPeriodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®) |
| ePTFE Non absorbable suture | Experimental | Drug: PolytetrafluoroethylenePeriodontal and periimplant flaps closed with at least one suture with ePTFE Non absorbable suture, synthetic, 4-0. (TAGUM®) |
| Nylon Non absorbable sutures | Experimental | Drug: PolyamidePeriodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must have read, understood and signed the informed consent form. Subject must require either open flap debridement surgery or implant placement (one to three consecutive teeth replacement) surgery.
- Subjects must be males or females who are a minimum of 20 years of age. No history of periodontal or implant surgery at the investigational area site within the past 12 months.
- Periodontal probing depths ≥5 mm interdentally at the implant site. Subjects that received single interrupted sutures for flap closure following surgical procedures.
Key exclusion criteria (3 listed)
- Subject is part of a vulnerable population will be excluded. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
- Subjects with a systemic disease that would preclude periodontal surgery. Subjects who are smokers or chew tobacco. Subjects that received periodontal dressing on the surgical area. Subjects with the presence of acute infectious lesions in the areas intended for surgery.
- Subjects with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results.
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 |
|---|---|---|
| Polyglycolic AcidPeriodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®). | Drug | Polyglycolic Acid Absorbable suture |
| CatgutPeriodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®) | Drug | Chromic Gut Absorbable suture |
| PolytetrafluoroethyleneAlso: ePTFEPeriodontal and periimplant flaps closed with at least one suture with expanded Polytetrafluoroethylene Non absorbable suture, synthetic, 4-0. (TAGUM®) | Drug | ePTFE Non absorbable suture |
| PolyamideAlso: NylonPeriodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®) | Drug | Nylon Non absorbable sutures |
Primary outcome
healing changes around each suture material
Time frame: 1 week, 2 weeks 1 month and 3 months after surgery.
To determinate the healing changes around each suture material using the Healing Index of Landry and colleagues (1988)
Tensile and mechanical properties of each suture material
Time frame: following 1 week of clinical application.
Evaluation of the tensile mechanical properties of each suture material using a Chatilloin TCD200 jig attachment, and tensile load will be applied to each suture at 0.05N/mm per min. Each suture will be stretched to failure and the maximum load will be recorded in Newtons (N).
Biofilm formation around each suture material
Time frame: following 1 week of clinical application.
To determinate the biofilm formation around each suture material using PCR
3 secondary outcomes
complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue
Time frame: 1 week, 2 weeks, 1 month and 3 months after surgery.
plaque adherence over sutures, number of sutures present and number of stable (untied) sutures
Time frame: 1 week after surgery.
subject satisfaction
Time frame: 1 week and 3 months following surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: No
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.
Ismael Khouly, PhD principal investigator
New York University
Questions about this trial
What is this clinical trial studying?
A study testing Polyglycolic Acid, Catgut and Polytetrafluoroethylene in people with Suture Adverse Reaction and Suture; Complications, Mechanical, run by Universidad Científica del Sur.
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 21 Jan 2020. 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 Carmen Castro Ruiz, DDS (+51952392367, dra.castroruiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing changes around each suture material (time frame: 1 week, 2 weeks 1 month and 3 months after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2020.